Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT04788433
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2021-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2021-03-07', 'studyFirstSubmitQcDate': '2021-03-07', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycomic profile as predictor of long-term morbidity', 'timeFrame': '1 year', 'description': 'Analysis of total plasmatic and IgG glycans composition; analysis of IgG glycopeptides. Correlation with pain, severity of the disease and long-term functional rehabilitation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Morbidity, Multiple', 'Covid19']}, 'descriptionModule': {'briefSummary': 'COVID infection has resulted in multi-organ injury and may result in cardiovascular, pulmonary, neurological, and muscular damage. It is associated with significant asthenia and the long-term effects of the infection are still unclear, particularly for the development of pain and delayed functional rehabilitation.\n\nGlycomics "is the systematic study of the structure of glycans in a given cell type or organism. Glycans are complex oligosaccharides attached to proteins and lipids that regulate a variety of organic processes, including immunity Thus, glycans may influence different moments of the response to the virus and involved in the clinical severity of the disease, but may also change depending on the severity of symptoms and the organic response to SARS-CoV-2 infection.\n\nGlycomic data could provide important insights into interindividual differences at the molecular level that directly interact with SARS-CoV-2 and the development of mid- and long-term side effects. The ability to identify early those susceptible to developing COVID-19 infection and at higher risk for COVID-19 with unfavorable outcomes long after infection would help guide therapeutic strategy and provide important guidance for rational health care organization, which is of outmost importance.\n\nLong-term outcome data regarding post-COVID patient functional capacity and glycomics will be compared to assess whether there may be differences in protein glycosylation that may predict patient outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with documented infection by Sars-CoV2 with different degrees of clinical severity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)\n* Age \\>18 years\n* Able to express informed consent to participate in the study\n\nExclusion Criteria:\n\n* patients unable to express consent,\n* patients aged \\<18 yr,\n* with signs and symptoms compatible with Covid-19 but without certified diagnosis by swab/BAL or serological examination of presence of COVID IgG antibodies'}, 'identificationModule': {'nctId': 'NCT04788433', 'acronym': 'ROCCO', 'briefTitle': 'Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Papa Giovanni XXIII Hospital'}, 'officialTitle': 'ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and Correlation With Glycomic Profile in COVID-19 Patients', 'orgStudyIdInfo': {'id': 'ROCCO-197/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ROCCO-A (A-symptomatic)', 'description': 'Patients with documented COVID-19 infection and NO symptoms', 'interventionNames': ['Diagnostic Test: glycomic analysis', 'Other: Phone interview']}, {'label': 'ROCCO-P (Pauci-symptomatic)', 'description': 'Patients with documented COVID-19 infection and mild symptoms but NO oxygen support)', 'interventionNames': ['Diagnostic Test: glycomic analysis', 'Other: Phone interview']}, {'label': 'ROCCO-L (mild)', 'description': 'Patients with documented COVID-19 infection and mild severity - requiring OXIGEN SUPPORT', 'interventionNames': ['Diagnostic Test: glycomic analysis', 'Other: Phone interview']}, {'label': 'ROCCO-M (moderate)', 'description': 'Patients with documented COVID-19 infection and moderate severity - requiring OXIGEN SUPPORT by NON-INVASIVE modalities', 'interventionNames': ['Diagnostic Test: glycomic analysis', 'Other: Phone interview']}, {'label': 'ROCCO-S(severe)', 'description': 'Patients with documented COVID-19 infection and severe disease requiring INVASIVE VENTILATION OR EXTRACORPOREAL MEMBRANE OXYGENATION', 'interventionNames': ['Diagnostic Test: glycomic analysis', 'Other: Phone interview']}], 'interventions': [{'name': 'glycomic analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Analysis of glycans on plasma samples', 'armGroupLabels': ['ROCCO-A (A-symptomatic)', 'ROCCO-L (mild)', 'ROCCO-M (moderate)', 'ROCCO-P (Pauci-symptomatic)', 'ROCCO-S(severe)']}, {'name': 'Phone interview', 'type': 'OTHER', 'description': 'patients are followed up by phone up to 1 year', 'armGroupLabels': ['ROCCO-A (A-symptomatic)', 'ROCCO-L (mild)', 'ROCCO-M (moderate)', 'ROCCO-P (Pauci-symptomatic)', 'ROCCO-S(severe)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Aast Papa Giovanni Xxiii', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papa Giovanni XXIII Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'GENOS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Dario Bugada', 'investigatorAffiliation': 'Papa Giovanni XXIII Hospital'}}}}