Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT05481216
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Greece', 'Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hivcoco@rokcservices.com', 'phone': '+44 (0) 7494 795 982', 'title': 'HIV COCO Project Manager', 'organization': 'Research Organization (KC) Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There are two analysis groups: exposed/unexposed (HIV+COVID-19+ and HIV-COVID-19+) and case-control (HIV+COVID-19+ and HIV+COVID-19-). There are limitations in data availability as this is a retrospective data collection study and all variables could not be collected for all participants. Multiple imputation using Chained Equations approach (MICE) was used to fill in missing data.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to week 6', 'description': 'Adverse events were not assessed were for this study, only deaths and serious adverse events were recorded(hospitalisations).', 'eventGroups': [{'id': 'EG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 486, 'otherNumAffected': 0, 'seriousNumAtRisk': 486, 'deathsNumAffected': 24, 'seriousNumAffected': 224}, {'id': 'EG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1106, 'otherNumAffected': 0, 'seriousNumAtRisk': 1106, 'deathsNumAffected': 23, 'seriousNumAffected': 231}], 'seriousEvents': [{'term': 'Mortality', 'notes': 'All cause mortality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1106, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalisation', 'notes': 'In patient hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 486, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 1106, 'numAffected': 208}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Composite Primary End Point (Critical Care Admission, Palliative Discharge When Discharged From Hospital, or Mortality Within the 6 Weeks After Diagnosis of COVID-19) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (diagnosis of COVID-19) to Week 6', 'description': 'The primary endpoint is a composite of the number of critical care admission (high dependency unit or intensive care unit), mortality in hospital or palliative discharge when discharged from hospital, or mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital (where applicable) events. Time-to-event methods, including Kaplan-Meier survival curves and Cox proportional-hazards models, will be used for this analysis. The time to the primary endpoints will be defined as:\n\n* For participants admitted to critical care Time = \\[Date of Critical care admission - Date of positive PCR test for COVID-19\\] + 1\n* For participants admitted to critical care before diagnosis of COVID-19, Time=1 day.\n* For participants with palliative discharge when discharged from hospital Time = \\[Date of discharge from hospital to palliative care - Date of positive PCR test for COVID-19\\] + 1.\n* For participants died Time = \\[Date of death - Date of positive PCR test for COVID-19\\] + 1.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 486 HIV+COVID+ cases included in the analysis as 14 cases lacked HIV-COVID+ inpatient controls and were excluded. This outcome was analysed in participants diagnosed with COVID-19 and is not applicable and not reported to the HIV+COVID-19- arm.'}, {'type': 'PRIMARY', 'title': 'Kaplan-Meier Estimate of Primary End Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '17.0'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '7.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.29', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Unadjusted and adjusted hazard ratios (HR) will be calculated using a proportional Cox regression model. The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.29', 'groupDescription': 'The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (diagnosis of COVID-19 ) to week 6', 'description': 'Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events', 'unitOfMeasure': 'percentage of events', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 486 HIV+COVID+ cases included in the analysis as 14 cases lacked HIV-COVID+ inpatient controls and were excluded. This measure was analysed in participants diagnosed with COVID-19 and is not reported for the HIV+COVID-19- arm.'}, {'type': 'PRIMARY', 'title': 'Number of Palliative Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls. This measure was analysed for participants with COVID-19 .It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.'}, {'type': 'PRIMARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls and were excluded. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.'}, {'type': 'PRIMARY', 'title': 'Number of Critical Care Admission Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Number of admission events to a high dependency unit or intensive care unit', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': '486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls and were excluded. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.'}, {'type': 'PRIMARY', 'title': 'HIV Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}], 'classes': [{'title': '<50', 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '888', 'groupId': 'OG001'}]}]}, {'title': '≥50', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load', 'unitOfMeasure': 'copies/ml', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria: Age (+/- 5 years); Sex; Ethnicity (where available). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalisation Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Number of hospital admission for COVID-19 events', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': '486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked HIV-COVID+ inpatient controls and were excluded. This measure was analysed for participants hospitalised with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '12'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Length of stay in hospital following hospitalisation for COVID-19', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '486 HIV+COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked HIV-COVID+ inpatient controls and were excluded. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.'}, {'type': 'SECONDARY', 'title': 'Length of Stay in ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '1106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '33'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Median Length of Stay in Intensive Care Unit', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '486 HIV+COVID+ vs HIV-COVID+ were included in the analysis as 14 HIV+COVID+ cases lacked COVID+ inpatient controls. This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days (VFDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'timeFrame': '6 weeks after diagnosis of COVID-19', 'description': 'Number of ventilator-free days', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'SECONDARY', 'title': 'Extracorporeal Membrane Oxygenation (ECMO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Length of extracorporeal membrane oxygenation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'SECONDARY', 'title': 'Need for Kidney Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline(diagnosis of COVID-19) to week 6', 'description': 'The number of patients requiring kidney replacement therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm. Kidney replacement data was not available for all participants in the HIV+COVID+ and HIV-COVID+ groups due to the retrospective nature of this study, and was only collected for 129 participants per group.'}, {'type': 'SECONDARY', 'title': 'Measurement of Total Comorbidity Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '2.83'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '1.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after diagnosis of COVID-19', 'description': 'Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Index consists of 19 conditions, each with an assigned weight from 1 to 6 according to the relative risk of dying. The total score is derived by summing up the weights of comorbid conditions presented. Based on the CCI score, the severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. The minimum score value is 0 and maximum is 37. A higher score means a more greater mortality risk.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm. Co-morbidity data required to analyse this measure was not available for all participants in the HIV+COVID+ and HIV-COVID+ groups due to the retrospective nature of this study, and was only collected for 170 participants per group.'}, {'type': 'SECONDARY', 'title': 'Estimate Risk of 30-day Mortality After COVID-19 Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '5.03'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '3.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Estimate risk of 30-day mortality after COVID-19 infection using pre-COVID health status (estimated using the Veterans Health Administration COVID-19 (VACO) index). The VACO index is expressed as a percentage and calculated based on age, sex, Charlson comorbidity index (CCI), and the presence of myocardial infarction (MI) or peripheral vascular disease (PVD). The index range is from 0.2 to 48.0. A higher score means a greater risk of mortality.', 'unitOfMeasure': 'percentage of 30- day mortality risk', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was analysed for participants with COVID-19. It is not applicable for COVID-19- participants and not reported for the HIV+COVID-19- arm. Data required to analyse this measure was not available for all participants in the HIV+COVID+ and HIV-COVID+ groups due to the retrospective nature of this study, and was only collected for 172 participants per group.'}, {'type': 'SECONDARY', 'title': 'Blood Cell Counts at COVID-19 Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'title': 'Platelet count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '212.1', 'groupId': 'OG000', 'lowerLimit': '199.4', 'upperLimit': '224.9'}, {'value': '237.2', 'groupId': 'OG001', 'lowerLimit': '221.9', 'upperLimit': '252.5'}]}]}, {'title': 'WBC count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '7.7'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '8.0'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '8.8'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '10.5'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.6'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.3'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.8'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.08'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.22'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.07'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Diagnosis of COVID-19)', 'description': 'The endpoint is the blood cell counts at COVID-19 diagnosis. The analyses will be performed with all PLHIV with COVID-19 and matched HIV-uninfected individual with COVID-19 who have data regarding the blood cell count of interest at COVID-19 diagnosis', 'unitOfMeasure': '10^9/L cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the retrospective nature of this data collection study, not all patients in the PLWHIV with COVID and the HIV seronegative with COVID groups had blood cell counts available and could not be included in the analysis. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group.'}, {'type': 'SECONDARY', 'title': 'Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '54.4'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '54.4'}]}]}, {'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000', 'lowerLimit': '34.2', 'upperLimit': '76.3'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '45.0', 'upperLimit': '63.0'}]}]}, {'title': 'Lactate dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '357.5', 'groupId': 'OG000', 'lowerLimit': '313.4', 'upperLimit': '401.5'}, {'value': '412.2', 'groupId': 'OG001', 'lowerLimit': '361.3', 'upperLimit': '463.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis.', 'unitOfMeasure': 'U/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had liver function data available and could not be included in the analysis. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Markers and Kidney Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.8'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.8'}]}]}, {'title': 'Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '63.2'}, {'value': '39.7', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '44.7'}]}]}, {'title': 'Serum creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '2.3'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.3'}]}]}, {'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.5'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (COVID-19 Diagnosis)', 'description': 'Inflammatory markers and Kidney Function tests at COVID-19 diagnosis', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had kidney function and inflammatory marker data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Biological Parameters at COVID-19 Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'title': 'D-dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1653.8', 'groupId': 'OG000', 'lowerLimit': '1131.1', 'upperLimit': '2176.6'}, {'value': '1561.9', 'groupId': 'OG001', 'lowerLimit': '1071.8', 'upperLimit': '2052.1'}]}]}, {'title': 'Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1039.5', 'groupId': 'OG000', 'lowerLimit': '681.2', 'upperLimit': '1397.7'}, {'value': '1113.0', 'groupId': 'OG001', 'lowerLimit': '820.1', 'upperLimit': '1405.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had D-dimer and Ferritin levels data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Cholesterol, Triglyceride and Glucose Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.7'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.3'}]}]}, {'title': 'Total Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.9'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.3'}]}]}, {'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '7.7'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Cholesterol, Triglyceride and Glucose data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '4.5'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 Diagnosis)', 'description': 'Red blood cell (RBC) count at COVID-19 Diagnosis', 'unitOfMeasure': '10^12/L cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Red Blood Cell count data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Haemoglobin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '13.3'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Haemoglobin levels at COVID-19 diagnosis', 'unitOfMeasure': 'g/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Haemoglobin data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Haematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '3.2'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (COVID-19 diagnosis)', 'description': 'Haematocrit levels at COVID-19 diagnosis', 'unitOfMeasure': 'L/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had Haematocrit data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'MCV Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '90.3', 'upperLimit': '92.5'}, {'value': '87.3', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '88.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis', 'unitOfMeasure': 'fL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had MCV data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'MCH Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '30.7'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '29.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis', 'unitOfMeasure': 'pg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had MCH data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'HbA1C Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '118.9'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '213.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis', 'unitOfMeasure': 'mmol/mol', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had HbA1C data available and could not be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'C-reactive Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '15.8'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '17.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'C-reactive protein levels at COVID-19 diagnosis', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses was performed with PLHIV with COVID-19 and matched HIV-uninfected with COVID-19 patients. The endpoint is only applicable to patients with COVID-19, therefore data is not reported for the PLWHIV without COVID-19 group. Due to the retrospective nature of this data collection study, not all patients in the PLWHIV+COVID-19+ and the HIV-COVID-19 + groups had CRP data available and could not be included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Time Since HIV Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.99', 'groupDescription': 'Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis', 'unitOfMeasure': 'per 10 unit of the model', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria: Age (+/- 5 years); Sex; Ethnicity (where available). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.'}, {'type': 'PRIMARY', 'title': 'Chronic Obstructive Pulmonary Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.93', 'ciLowerLimit': '1.16', 'ciUpperLimit': '3.22', 'groupDescription': 'Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria: Age (+/- 5 years); Sex; Ethnicity (where available). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.'}, {'type': 'PRIMARY', 'title': 'CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '630', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.02', 'groupDescription': 'Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count', 'unitOfMeasure': 'per 100 unit for the model', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria: Age (+/- 5 years); Sex; Ethnicity (where available). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.'}, {'type': 'PRIMARY', 'title': 'Chronic Kidney Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.71', 'ciLowerLimit': '1.61', 'ciUpperLimit': '4.57', 'groupDescription': 'Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria: Age (+/- 5 years); Sex; Ethnicity (where available). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.'}, {'type': 'PRIMARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'OG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '91'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '88'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '1.34', 'ciUpperLimit': '2.25', 'groupDescription': 'Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight', 'unitOfMeasure': 'kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population will consist of PLHIV and COVID-19 with matched PLHIV without COVID-19. 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria: Age (+/- 5 years); Sex; Ethnicity (where available). Because some of the variables studied will have missing values, multiple imputation using Chained Equations approach (MICE) will be used to fill in missing data. Ten imputations (M=10) will be chosen.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'FG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'FG002', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '992'}, {'groupId': 'FG002', 'numSubjects': '1106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '992'}, {'groupId': 'FG002', 'numSubjects': '1106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'PLWH were identified from European sites in the NEAT ID network. PLWH are routinely followed-up at specialized outpatient clinics with regular follow up visits as standard of care. HIV-COVID+ inpatient controls were from the same sites of the NEAT ID network. HIV-COVID-19+ outpatient controls were from the anonymized real-world primary care medical database THIN.', 'preAssignmentDetails': 'PCR-confirmed SARS-CoV-2 infected PLWH (HIV+COVID+) were matched 1:1(outpatient) or 1:3(inpatient )against HIV negative PCR-confirmed COVID-19-infected individuals (HIV-COVID+) and 1:2 COVID-19 negative PLWH (HIV+COVID-).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PLWHIV With COVID-19 Cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'BG001', 'title': 'PLWHIV Without COVID-19 Controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.\n\nHIV-1 infection: Diagnosed with HIV-1 infection'}, {'id': 'BG002', 'title': 'HIV Seronegative Patients With COVID-19 Controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\nCOVID-19: Diagnosed with COVID-19 infection'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '52', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '51', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '51.6', 'spread': '11.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age (years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'title': '<60 years', 'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '778', 'groupId': 'BG001'}, {'value': '878', 'groupId': 'BG002'}, {'value': '2044', 'groupId': 'BG003'}]}, {'title': '≥ 60 years', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '554', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '348', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}, {'value': '933', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '644', 'groupId': 'BG001'}, {'value': '697', 'groupId': 'BG002'}, {'value': '1665', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}, {'value': '1836', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White Caucasian', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '464', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '838', 'groupId': 'BG003'}]}, {'title': 'White Mixed', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '578', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Not stated', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity was not available for 762 HIV-COVID-19+ outpatient control cases obtained from the anonymized real-world primary care medical database THIN.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}, {'value': '693', 'groupId': 'BG003'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '682', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '965', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '2598', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}, {'value': '602', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Month of COVID-19 diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '1592', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '102020', 'groupId': 'BG000', 'lowerLimit': '042020', 'upperLimit': '122020'}, {'value': '102020', 'groupId': 'BG002', 'lowerLimit': '042020', 'upperLimit': '122020'}, {'value': '102020', 'groupId': 'BG003', 'lowerLimit': '042020', 'upperLimit': '122020'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'month/year', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. 486 HIV+COVID+ cases were included in the HIV+COVID+ vs HIV-COVID+ analysis because 14 cases lacked HIV-COVID+ inpatient controls and were excluded.'}, {'title': 'COVID-19 diagnosis location', 'classes': [{'title': 'Inpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '1592', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG002'}, {'value': '352', 'groupId': 'BG003'}]}]}, {'title': 'Outpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1106', 'groupId': 'BG002'}, {'value': '1592', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '930', 'groupId': 'BG002'}, {'value': '1240', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Diagnosis location', 'populationDescription': '486 HIV+COVID+ vs HIV-COVID+ included in the analysis because 14 cases lacked COVID+ inpatient controls.'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'BG000'}, {'value': '943', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}, {'value': '2201', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '79', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '81', 'spread': '19.1', 'groupId': 'BG002'}, {'value': '80.4', 'spread': '17.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Due to the retrospective nature of this data collection study, data collection was limited to available data. Baseline weight characteristics were available for 479 HIV+COVID-19+ cases, 779 HIV-COVID+ controls and 943 HIV+COVID- controls'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'BG000'}, {'value': '847', 'groupId': 'BG001'}, {'value': '581', 'groupId': 'BG002'}, {'value': '1856', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '28.7', 'spread': '6.2', 'groupId': 'BG002'}, {'value': '27.7', 'spread': '5.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Due to the retrospective nature of this data collection study, data collection was limited to available data. Baseline body mass index data only available for 428 COVID-19+HIV+ cases, 847 COVID-19- HIV+ and 581 COVID-19+HIV- controls.'}, {'title': 'Comorbidities', 'classes': [{'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Congestive Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Peripheral Vascular Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}, {'value': '1836', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}, {'title': 'Cerebrovascular Accident', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Dementia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}, {'value': '1836', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Chronic Obstructive Pulmonary Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}, {'title': 'History of Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}]}]}, {'title': 'Connective Tissue Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}]}]}, {'title': 'Peptic Ulcer Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}, {'title': 'Liver Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}]}, {'title': 'Hemiplegia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}, {'value': '1836', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Paralysis of Arm(s) or Leg(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Chronic Kidney Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'Current or history of Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}, {'title': 'Leukemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Lymphoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}, {'value': '2126', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the retrospective nature of this data collection study, data collection was limited to available data. Baseline comorbidity data was only available for 634 HIV-COVID+ controls except for peripheral vascular disease, dementia and hemiplegia which was only available for 344 controls.'}, {'title': 'Drug treatment for COVID-19', 'classes': [{'title': 'Glucocorticoids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Azithromycin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}, {'title': 'Other antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}, {'title': 'Hydroxychloroquine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}, {'title': 'Remdesivir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Tocilizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Monoclonal antibodies against SARS-CoV2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Reconvalescent plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Anti-IL1 Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Anti-IL6 Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Lopinavir/ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}, {'title': 'Anticoagulants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Others', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Drug treatment data was not available for the overall population'}, {'title': 'Blood cell counts at COVID-19 diagnosis', 'classes': [{'title': 'Platelet count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '365', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '212', 'spread': '87.9', 'groupId': 'BG000'}, {'value': '237', 'spread': '105.5', 'groupId': 'BG002'}, {'value': '225', 'spread': '97.9', 'groupId': 'BG003'}]}]}, {'title': 'WBC count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}, {'value': '361', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '4.1', 'groupId': 'BG002'}, {'value': '7.3', 'spread': '3.8', 'groupId': 'BG003'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '334', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '13.2', 'groupId': 'BG003'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}, {'value': '339', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '3.2', 'groupId': 'BG002'}, {'value': '1.9', 'spread': '3.6', 'groupId': 'BG003'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '337', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '0.7', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '0.8', 'spread': '2.5', 'groupId': 'BG003'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '328', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.12', 'groupId': 'BG000'}, {'value': '0.13', 'spread': '0.59', 'groupId': 'BG002'}, {'value': '0.10', 'spread': '0.42', 'groupId': 'BG003'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.17', 'groupId': 'BG000'}, {'value': '0.04', 'spread': '0.16', 'groupId': 'BG002'}, {'value': '0.05', 'spread': '0.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^9/L cells', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the retrospective nature of this data collection study, data collection was limited to available data. Blood cell counts were not available for all participants'}, {'title': 'Inflammatory Markers and Kidney Function Tests', 'classes': [{'title': 'Total bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '0.7', 'spread': '0.9', 'groupId': 'BG003'}]}]}, {'title': 'Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '289', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52.6', 'spread': '64.0', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '30.2', 'groupId': 'BG002'}, {'value': '46.1', 'spread': '50.3', 'groupId': 'BG003'}]}]}, {'title': 'Serum creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '1.4', 'spread': '2.5', 'groupId': 'BG003'}]}]}, {'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '9.0', 'groupId': 'BG002'}, {'value': '5.3', 'spread': '6.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Inflammatory Markers and Kidney Function Tests were not available for all participants and could not be collected.'}, {'title': 'RBC Count at COVID-19 Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '4.5', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^12/L cells', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Blood cell counts were not available for all participants and could not be collected'}, {'title': 'Haemoglobin at COVID-19 diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}, {'value': '361', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '13.1', 'spread': '2.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to COVID+ participants and was not collected for HIV+COVID- controls. As this is a real world retrospective data collection study, there are limitations in data availability and Haemoglobin values were not available for all participants. Data was available for 178 HIV+COVID+ cases and 183 HIV-COVID+ controls.'}, {'title': 'Haematocrit at COVID-19 diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '351', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '3.3', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '3.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Haematocrit not available for all participants in the analysis population'}, {'title': 'Glucose, Cholesterol and Triglycerides at COVID-19 diagnosis', 'classes': [{'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '5.1', 'groupId': 'BG002'}, {'value': '7.2', 'spread': '4.4', 'groupId': 'BG003'}]}]}, {'title': 'Total cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.8', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '4.1', 'spread': '1.1', 'groupId': 'BG003'}]}]}, {'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '1.8', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Data was not available for all participants in the analysis population'}, {'title': 'MCV at COVID diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '91.4', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '87.3', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '89.3', 'spread': '8.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'fL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Data was not available for all participants in the analysis population'}, {'title': 'MCH at COVID-19 diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '2.4', 'groupId': 'BG002'}, {'value': '29.6', 'spread': '2.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Data was not available for all participants in the analysis population'}, {'title': 'Lactate dehydrogenase, ALT and AST levels at COVID-19 diagnosis', 'classes': [{'title': 'ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '78.9', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '44.7', 'groupId': 'BG002'}, {'value': '44.7', 'spread': '63.9', 'groupId': 'BG003'}]}]}, {'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55.2', 'spread': '118.4', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '50.5', 'groupId': 'BG002'}, {'value': '54.6', 'spread': '90.6', 'groupId': 'BG003'}]}]}, {'title': 'Lactate dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '357.5', 'spread': '205.3', 'groupId': 'BG000'}, {'value': '412.2', 'spread': '237.1', 'groupId': 'BG002'}, {'value': '384.9', 'spread': '222.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Data not available for all participants in the analysis population'}, {'title': 'HbA1C levels at COVID-19 diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '36.7', 'groupId': 'BG000'}, {'value': '99.9', 'spread': '72.0', 'groupId': 'BG002'}, {'value': '79.9', 'spread': '56.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection study, data collection was limited to available data. Data was not available for all participants in the analysis population'}, {'title': 'C-Reactive Protein (CRP) at COVID-19 diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '18.7', 'groupId': 'BG000'}, {'value': '13.6', 'spread': '21.8', 'groupId': 'BG002'}, {'value': '13.1', 'spread': '20.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection, data collection was limited to available data. CRP levels were not available for all participants and could not be collected'}, {'title': 'Ferritin and D-dimer levels at COVID-19 diagnosis', 'classes': [{'title': 'Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1039.5', 'spread': '1398.8', 'groupId': 'BG000'}, {'value': '1113.0', 'spread': '1143.6', 'groupId': 'BG002'}, {'value': '1076.6', 'spread': '1271.5', 'groupId': 'BG003'}]}]}, {'title': 'D-dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1653.8', 'spread': '2452.7', 'groupId': 'BG000'}, {'value': '1561.9', 'spread': '2299.8', 'groupId': 'BG002'}, {'value': '1607.9', 'spread': '2371.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the HIV-COVID+ and HIV+COVID+ populations. Due to the nature of this retrospective data collection, data collection was limited to available data. Ferritin levels and D-dimer were not available for all participants and could not be analysed.'}, {'title': 'Time since HIV diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'BG000'}, {'value': '977', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1469', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '18.7', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '18.4', 'spread': '9.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure not applicable to HIV seronegative population. Due to the nature of this retrospective data collection study, data collection was limited to available data. Data was not available for all participants and could not be analysed.'}, {'title': 'CD4 cell count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'BG000'}, {'value': '971', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1460', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '654', 'spread': '332.9', 'groupId': 'BG000'}, {'value': '669', 'spread': '321.9', 'groupId': 'BG001'}, {'value': '664', 'spread': '325.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure not applicable to HIV seronegative population. Due to the nature of this retrospective data collection study, data collection was limited to available data. CD4 count was not available for all participants and could not be analysed.'}, {'title': 'HIV viral load', 'classes': [{'title': '<50 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'BG000'}, {'value': '976', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1468', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '878', 'groupId': 'BG001'}, {'value': '1301', 'groupId': 'BG003'}]}]}, {'title': '≥50 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'BG000'}, {'value': '976', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1468', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This measure not applicable to HIV seronegative population. Due to the nature of this retrospective data collection study, data collection was limited to available data. HIV viral load was not available for all participants and could not be analysed.'}], 'populationDescription': '486 HIV+COVID+ cases were included in the analysis of HIV+COVID+ vs HIV-COVID+ (14 cases lacked COVID+ inpatient controls).Co-morbidities were only available for 395 cases except for peripheral vascular disease, dementia and hemiplegia which were available for 320 cases. The case and control groups do not come from the same population and could not be grouped together for all baseline characteristics. Total population data that could be calculated from the data collected has been reported.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-29', 'size': 514692, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-30T09:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2598}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2022-07-29', 'resultsFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-03', 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Composite Primary End Point (Critical Care Admission, Palliative Discharge When Discharged From Hospital, or Mortality Within the 6 Weeks After Diagnosis of COVID-19) Events', 'timeFrame': 'From baseline (diagnosis of COVID-19) to Week 6', 'description': 'The primary endpoint is a composite of the number of critical care admission (high dependency unit or intensive care unit), mortality in hospital or palliative discharge when discharged from hospital, or mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital (where applicable) events. Time-to-event methods, including Kaplan-Meier survival curves and Cox proportional-hazards models, will be used for this analysis. The time to the primary endpoints will be defined as:\n\n* For participants admitted to critical care Time = \\[Date of Critical care admission - Date of positive PCR test for COVID-19\\] + 1\n* For participants admitted to critical care before diagnosis of COVID-19, Time=1 day.\n* For participants with palliative discharge when discharged from hospital Time = \\[Date of discharge from hospital to palliative care - Date of positive PCR test for COVID-19\\] + 1.\n* For participants died Time = \\[Date of death - Date of positive PCR test for COVID-19\\] + 1.'}, {'measure': 'Kaplan-Meier Estimate of Primary End Point', 'timeFrame': 'From Baseline (diagnosis of COVID-19 ) to week 6', 'description': 'Kaplan-Meier estimate of the composite number of critical care admission, palliative discharge and death events'}, {'measure': 'Number of Palliative Discharge', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Number of palliative discharge at discharge from hospital following hospitalisation for COVID-19 events'}, {'measure': 'Mortality', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Mortality at 6 weeks after diagnosis of COVID-19 or at discharge from hospital'}, {'measure': 'Number of Critical Care Admission Events', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Number of admission events to a high dependency unit or intensive care unit'}, {'measure': 'HIV Viral Load', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: HIV viral load'}, {'measure': 'Time Since HIV Diagnosis', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Time since HIV diagnosis'}, {'measure': 'Chronic Obstructive Pulmonary Disease', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Obstructive Pulmonary Disease'}, {'measure': 'CD4 Cell Count', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: CD4 cell count'}, {'measure': 'Chronic Kidney Disease', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Chronic Kidney Disease'}, {'measure': 'Body Weight', 'timeFrame': 'Baseline(Last CD4 cell count and HIV-RNA before COVID-19 diagnosis, or most recent for PLHIV without COVID-19)', 'description': 'Identification of risk factors for COVID-19 infection within the group of PLHIV: Body weight'}], 'secondaryOutcomes': [{'measure': 'Number of Hospitalisation Events', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Number of hospital admission for COVID-19 events'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Length of stay in hospital following hospitalisation for COVID-19'}, {'measure': 'Length of Stay in ICU', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Median Length of Stay in Intensive Care Unit'}, {'measure': 'Ventilator-free Days (VFDs)', 'timeFrame': '6 weeks after diagnosis of COVID-19', 'description': 'Number of ventilator-free days'}, {'measure': 'Extracorporeal Membrane Oxygenation (ECMO)', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Length of extracorporeal membrane oxygenation'}, {'measure': 'Need for Kidney Replacement Therapy', 'timeFrame': 'Baseline(diagnosis of COVID-19) to week 6', 'description': 'The number of patients requiring kidney replacement therapy'}, {'measure': 'Measurement of Total Comorbidity Burden', 'timeFrame': '6 weeks after diagnosis of COVID-19', 'description': 'Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Index consists of 19 conditions, each with an assigned weight from 1 to 6 according to the relative risk of dying. The total score is derived by summing up the weights of comorbid conditions presented. Based on the CCI score, the severity of comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. The minimum score value is 0 and maximum is 37. A higher score means a more greater mortality risk.'}, {'measure': 'Estimate Risk of 30-day Mortality After COVID-19 Infection', 'timeFrame': 'Baseline (diagnosis of COVID-19) to week 6', 'description': 'Estimate risk of 30-day mortality after COVID-19 infection using pre-COVID health status (estimated using the Veterans Health Administration COVID-19 (VACO) index). The VACO index is expressed as a percentage and calculated based on age, sex, Charlson comorbidity index (CCI), and the presence of myocardial infarction (MI) or peripheral vascular disease (PVD). The index range is from 0.2 to 48.0. A higher score means a greater risk of mortality.'}, {'measure': 'Blood Cell Counts at COVID-19 Diagnosis', 'timeFrame': 'Baseline (Diagnosis of COVID-19)', 'description': 'The endpoint is the blood cell counts at COVID-19 diagnosis. The analyses will be performed with all PLHIV with COVID-19 and matched HIV-uninfected individual with COVID-19 who have data regarding the blood cell count of interest at COVID-19 diagnosis'}, {'measure': 'Liver Function and Tissue Damage Parameters at COVID-19 Diagnosis', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'The endpoint is the liver function (ALT, AST) and tissue damage (lactate dehydrogenase) parameters at COVID-19 diagnosis.'}, {'measure': 'Inflammatory Markers and Kidney Function Tests', 'timeFrame': 'Baseline (COVID-19 Diagnosis)', 'description': 'Inflammatory markers and Kidney Function tests at COVID-19 diagnosis'}, {'measure': 'Biological Parameters at COVID-19 Diagnosis', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Biological parameters (D-dimer and Ferritin levels) at COVID-19 diagnosis'}, {'measure': 'Cholesterol, Triglyceride and Glucose Levels', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Cholesterol, Triglyceride and Glucose levels at COVID-19 diagnosis'}, {'measure': 'Red Blood Cell Count', 'timeFrame': 'Baseline(COVID-19 Diagnosis)', 'description': 'Red blood cell (RBC) count at COVID-19 Diagnosis'}, {'measure': 'Haemoglobin Levels', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Haemoglobin levels at COVID-19 diagnosis'}, {'measure': 'Haematocrit', 'timeFrame': 'Baseline (COVID-19 diagnosis)', 'description': 'Haematocrit levels at COVID-19 diagnosis'}, {'measure': 'MCV Levels', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Mean Corpuscular volume (MCV) levels at COVID-19 diagnosis'}, {'measure': 'MCH Levels', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Mean Corpuscular Haemoglobin levels at COVID-19 diagnosis'}, {'measure': 'HbA1C Levels', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'Glycated Haemoglobin (HbA1C) levels at COVID-19 diagnosis'}, {'measure': 'C-reactive Protein Levels', 'timeFrame': 'Baseline(COVID-19 diagnosis)', 'description': 'C-reactive protein levels at COVID-19 diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'HIV CoCo is a European multi-centre, multi-country, retrospective, observational case-control study that will aim to describe clinical outcomes and identify risk factors for People Living With HIV (PLWHIV) who are co-infected with the SARS-CoV-2 coronavirus.\n\nThe study will address two central questions:\n\n1. Is there a particular risk for COVID-19 in PLWHIV as compared to HIV seronegative control COVID-19 cases?\n2. Are there particular factors, within the group of PLWHIV, which put them at risk for a more severe COVID-19 disease course?\n\nThe study will address these questions by recruiting patients co-infected with both HIV and SARS-CoV-2 and comparing them to two control groups - one group infected with SARS-CoV-2 only and another group infected with HIV only. Only deidentified, real-world retrospective data will be used for the study, collected as part of standard, routine clinical care.\n\nAdditionally, this study will also look to:\n\n1. Describe the differences in the clinical manifestation of COVID-19 in PLWHIV compared to HIV seronegative controls\n2. Describe the response to treatment, including supportive care and novel therapies against COVID-19, including antiviral or immunomodulatory therapy\n3. Describe the co-morbidities in PLWHIV and controls with COVID-19\n4. Compare the severity of COVID-19 between PLWHIV and the COVID-19 only controls at diagnosis and hospital admission.\n\nData will be collected about patient outcomes from COVID-19 (including hospitalisation for COVID-19, length of stay in hospital, critical care admission, ventilation/oxygenation requirements, and need for kidney replacement therapy), as well as pre-existing health conditions, and relevant blood results at COVID-19 diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult PLWHIV with and without COVID-19 disease, followed up at the study sites for routine clinical care. Data from adult COVID-19 patients without HIV infection will be used as controls.\n\n500 cases (PLWHIV + COVID-19) will be recruited. These patients will be at least 18 years old with documented HIV-1 infection and SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\n500 COVID-19 controls will be recruited. These patients will be at least 18 years old without documented HIV-1 infection but confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.\n\n1000 PLWHIV control patients will be recruited for the second control group. This group will include individuals at least 18 years old with documented HIV-1 infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Cases (PLWHIV + COVID-19)\n\n 1. Any gender\n 2. At least 18 years of age\n 3. Documented HIV-1 infection\n 4. Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021\n\n * Controls (COVID-19)\n\n <!-- -->\n\n 1. Any gender\n 2. At least 18 years of age\n 3. No documented HIV-1 infection\n 4. Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021\n 5. Meet the matching criteria\n\nFor comparing PLWHIV \\& COVID-19 versus HIV seronegative COVID-19 patients, a 1:1 matching will be performed according to the following criteria:\n\n* Age (+/- 5 years)\n* Sex\n* Ethnicity (where available)\n* Month of COVID-19 diagnosis (+/- 2 months)\n* COVID-19 diagnosis inpatient OR\n* COVID-19 diagnosis outpatient (ambulatory)\n* Controls (PLWHIV)\n\n 1. Any gender\n 2. At least 18 years of age\n 3. Documented HIV-1 infection\n 4. No evidence of SARS-CoV-2 infection\n 5. Meet the matching criteria\n\nFor comparing PLWHIV \\& COVID-19 versus PLWHIV without COVID-19, a 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria:\n\n* Age (+/- 5 years)\n* Sex\n* Ethnicity (where available)\n\nExclusion Criteria\n\nFor cases (PLWHIV + COVID-19) and for COVID-19 only controls:\n\n* COVID-19 diagnosed based on clinical criteria'}, 'identificationModule': {'nctId': 'NCT05481216', 'acronym': 'HIV CoCo', 'briefTitle': 'HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'NEAT ID Foundation'}, 'officialTitle': 'HIV-1 & Coronavirus-Coinfection in Europe: Morbidity & Risk Factors of COVID-19 in People Living With HIV', 'orgStudyIdInfo': {'id': '303CoCo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PLWHIV with COVID-19 cases', 'description': 'Patients who are at least 18 years of age with documented HIV-1 infection and confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.', 'interventionNames': ['Other: COVID-19', 'Other: HIV-1 infection']}, {'label': 'PLWHIV without COVID-19 controls', 'description': 'Patients at least 18 years of age with documented HIV-1 infection.', 'interventionNames': ['Other: HIV-1 infection']}, {'label': 'HIV seronegative patients with COVID-19 controls', 'description': 'Patients at least 18 years of age with confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021.', 'interventionNames': ['Other: COVID-19']}], 'interventions': [{'name': 'COVID-19', 'type': 'OTHER', 'description': 'Diagnosed with COVID-19 infection', 'armGroupLabels': ['HIV seronegative patients with COVID-19 controls', 'PLWHIV with COVID-19 cases']}, {'name': 'HIV-1 infection', 'type': 'OTHER', 'description': 'Diagnosed with HIV-1 infection', 'armGroupLabels': ['PLWHIV with COVID-19 cases', 'PLWHIV without COVID-19 controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Européen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital Universitario Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Elche', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'Logroño', 'country': 'Spain', 'facility': 'Hospital Universitario San Pedro', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Southmead Hospital (North Bristol)', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Derby', 'country': 'United Kingdom', 'facility': 'University Hospitals of Derby & Burton NHS Foundation Trust', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Brownlee Centre, Gartnavel General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health (The Royal London Hospital)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea & Westminster Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only anonymised summary-format data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NEAT ID Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}