Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04385251
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2020-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
International SARS-CoV-2 (COVID-19) Infection Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-16', 'size': 308240, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-09T16:58', 'hasProtocol': True}, {'date': '2020-08-21', 'size': 228108, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-09T16:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'At the time of enrollment, selected sites participating in a sub-study will be asked to obtain separate consents for 1) an upper respiratory swab and a blood sample sufficient for four 1mL transport tubes of serum to be shipped to a central repository for future research on COVID-19; and 2) co-enrollment in the INSIGHT Genomics Study (INSIGHT 004) where a blood sample sufficient for six 1mL aliquots of whole blood will be collected. These specimens will be sent to a central repository in the United States for storage.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11973}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Hospitalization', 'timeFrame': '28 days', 'description': 'Outcome reported as the mean number of days from enrollment to hospitalization due to COVID-19.'}, {'measure': 'Time to Expiration', 'timeFrame': '28 days', 'description': 'Outcome reported as the mean number of days from enrollment to expiration (death) due to COVID-19.'}], 'secondaryOutcomes': [{'measure': 'Rate of Death at 7 Days', 'timeFrame': '7 days', 'description': 'Outcome reported as the percent of participants who expire due to COVID-19 at 7 days post enrollment.'}, {'measure': 'Rate of Death at 14 Days', 'timeFrame': '14 days', 'description': 'Outcome reported as the percent of participants who expire due to COVID-19 at 14 days post enrollment.'}, {'measure': 'Rate of Death at 28 Days', 'timeFrame': '28 days', 'description': 'Outcome reported as the percent of participants who expire due to COVID-19 at 28 days post enrollment.'}, {'measure': 'Rate of Hospitalization at 7 Days', 'timeFrame': '7 days', 'description': 'Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 7 days post enrollment.'}, {'measure': 'Rate of Hospitalization at 14 Days', 'timeFrame': '14 days', 'description': 'Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 14 days post enrollment.'}, {'measure': 'Rate of Hospitalization at 28 Days', 'timeFrame': '28 days', 'description': 'Outcome reported as the percent of participants who are hospitalized due to COVID-19 at 28 days post enrollment.'}, {'measure': 'Participant Health at 7 Days', 'timeFrame': '7 days', 'description': 'Outcome reported as the percent of participants who are in excellent or very good health at 7 days post enrollment.'}, {'measure': 'Participant Health at 14 Days', 'timeFrame': '14 days', 'description': 'Outcome reported as the percent of participants who are in excellent or very good health at 14 days post enrollment.'}, {'measure': 'Participant Health at 28 Days', 'timeFrame': '28 days', 'description': 'Outcome reported as the percent of participants who are in excellent or very good health at 28 days post enrollment.'}, {'measure': 'Modified Borg Dyspnea Scale at 7 Days', 'timeFrame': '7 Days', 'description': 'The Modified Borg Dyspnea scale (MBDS) contains 12 numeric values which designate the severity of dyspnea symptoms (0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). Higher scores indicate greater dyspnea severity. Outcome is reported as the mean MBDS score at 7 days post enrollment.'}, {'measure': 'Modified Borg Dyspnea Scale at 14 Days', 'timeFrame': '14 Days', 'description': 'The Modified Borg Dyspnea scale (MBDS) contains 12 numeric values which designate the severity of dyspnea symptoms (0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). Higher scores indicate greater dyspnea severity. Outcome is reported as the mean MBDS score at 14 days post enrollment.'}, {'measure': 'Modified Borg Dyspnea Scale at 28 Days', 'timeFrame': '28 Days', 'description': 'The Modified Borg Dyspnea scale (MBDS) contains 12 numeric values which designate the severity of dyspnea symptoms (0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10). Higher scores indicate greater dyspnea severity. Outcome is reported as the mean MBDS score at 28 days post enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'COVID19', 'SARS-CoV 2', 'Dyspnea']}, 'descriptionModule': {'briefSummary': 'The general aim of this study is to estimate the rate of disease progression for adults testing positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-CoV-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment.\n\nSecondary outcomes include participant-reported health status and change in severity of dyspnoea.', 'detailedDescription': 'SARS-CoV-2 is a coronavirus that emerged in China in late 2019 causing a novel Corona-Virus Induced Disease (COVID-19). COVID-19 is spreading rapidly throughout the world. While a proportion of people with COVID-19 have sufficiently severe symptoms to require hospitalization at the time of initial symptom onset, in others the disease may remain mild, and in some cases there has been observed a worsening of symptoms a few days after initial presentation with relatively mild symptoms. There is an urgent need for understanding the progression of disease for individuals with SARS-CoV-2 infection/COVID-19 who do not require immediate hospitalization.\n\nThis is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 managed as outpatients (not hospitalized). This study will also be a platform for the enrollment of outpatients for randomized trials that will be conducted by the INSIGHT group.\n\nThose with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. Procedures and data collection have been streamlined to facilitate the enrollment of a large number of adults at INSIGHT sites around the world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who test positive for SARS-CoV-2 infection/COVID-19 will be followed for 28 days in an observational cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Not currently hospitalized\n\nExclusion Criteria:\n\n\\- Persons with a known positive SARS-CoV-2 test \\> 28 days ago'}, 'identificationModule': {'nctId': 'NCT04385251', 'acronym': 'ICOS', 'briefTitle': 'International SARS-CoV-2 (COVID-19) Infection Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'An International Observational Study of Outpatients With SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': 'ICOS'}, 'secondaryIdInfos': [{'id': '75N91019D00024', 'type': 'OTHER_GRANT', 'domain': 'Leidos Biomedical Research, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2 infection/COVID-19', 'description': 'Adults who present for SARS-CoV-2 testing will be consented for this study. Participants who are enrolled will be informed that if they have SARS-CoV-2 infection/COVID-19, they will be followed for 28 days in an observational cohort study, and that if they do not have SARS-CoV-2 infection, there will be no further follow-up.', 'interventionNames': ['Other: Data Collection']}], 'interventions': [{'name': 'Data Collection', 'type': 'OTHER', 'description': 'DATA COLLECTION AT ENROLLMENT:\n\nDemographics; Symptoms and health status; Co-morbidities; Targeted medications; Specimen Collection (substudy at selected sites): Upper respiratory swab, blood for serum storage.\n\nDATA COLLECTION AT DAYS 7, 14 \\& 28:\n\nVital and hospitalization status; Symptoms and health status', 'armGroupLabels': ['SARS-CoV-2 infection/COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Public Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': 'C1221ADC', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital General de Agudos JM Ramos Mejia Servicio de Inmunocomprometidos', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'CHIP Department of Infectious Diseases', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'WC1E', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University College London Medical School Centre for Sexual Health and HIV Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'James Neaton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}