Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-28 @ 1:12 AM
Study NCT ID:
NCT04359459
Status:
WITHDRAWN
Last Update Posted:
2022-11-04
First Post:
2020-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasal Epithelial Genetic and Single Cell RNA COVID-19 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Blood sampling: 1x serum, 1x plasma + buffycoat, 1x protease inhibitor tube, 1x PAXgene RNA tube\n* Nasal brushes: 5 nasal brushes will be collected, 1x RNAProtect Cell solution, 2x 10Xgenomic (single cell sequencing), 1 x DNA methylation in empty tube, 1 x in 2mL universal virus transport medium.\n* Stool sample - 1 tube'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID-19 pandemie ended', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal epithelial transcriptional response to SARS-CoV2', 'timeFrame': 'Observational-baseline', 'description': 'To assess how the nasal epithelial transcriptional response to SARS-CoV2 is different in patients with mild, severe, or very severe disease.'}], 'secondaryOutcomes': [{'measure': 'ACE2-AngII system', 'timeFrame': 'Observational-baseline', 'description': 'To assess the role of the ACE2-AngII system during SARS-CoV2 in relation to disease outcome (mild, severe, very severy COVID)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Rationale:\n\nThe investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients.\n\nObjective:\n\nThe main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \\& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development.\n\nStudy design:\n\nProspective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \\& 3 at day 3, at day 14, and before detubation\n\nStudy population:\n\nA total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups:\n\nGroup 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.\n\nGroup 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.\n\nGroup 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.\n\nMain study parameters/endpoints:\n\nThe primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.', 'detailedDescription': 'Rationale:\n\nThe currently ongoing world-crippling pandemic with the new SARS-CoV2 virus shows the desperate and urgent need for a better understanding of the biological pathways activated by the virus inducing Coronavirus disease 2019 (COVID-19) in infected patients. A subset of COVID-19 patients develop very severe respiratory symptoms requiring hospital admission with or without the need for mechanical ventilation, whereas others experience mild flu-like symptoms. The biological mechanisms underlying this striking difference in clinical outcome and the long term consequences are unknown, yet a genetic factor seems likely. SARS-CoV2 enters cells via the ACE2 receptor and the activating protease TMPRSS2 which have recently been shown to be strongly enriched in nasal epithelium. The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients.\n\nObjective:\n\nThe main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \\& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development.\n\nStudy design:\n\nProspective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \\& 3 at day 3, at day 14, and before detubation. Study subjects will be retrospectively allocated to the groups.\n\nStudy population:\n\nA total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups:\n\nGroup 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.\n\nGroup 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.\n\nGroup 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.\n\nMain study parameters/endpoints:\n\nThe primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.\n\nGroup 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.\n\nGroup 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients have to be tested (PCR) positive for SARS-CoV2 infection.\n2. Provided written informed consent\n\nExclusion Criteria:\n\n1\\. No comprehension of Dutch or English language'}, 'identificationModule': {'nctId': 'NCT04359459', 'acronym': 'CIPOLLINI', 'briefTitle': 'Nasal Epithelial Genetic and Single Cell RNA COVID-19 Study', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Nasal CIliated EPithelial Genetic And Single Cell RNA prOfiLes of miLd, Severe and Very Severe COVID-Nineteen patIents (CIPOLLINI) Study', 'orgStudyIdInfo': {'id': 'CIPOLLINI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild COVID-19', 'description': 'Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.'}, {'label': 'Severe COVID-19', 'description': 'Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.'}, {'label': 'Very Severe COVID-19', 'description': 'Patients with very severe disease admitted to intensive care, who require mechanical ventilation.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dirk-Jan Slebos, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMCG, Department of pulmonology'}, {'name': 'Janesh Pillay, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMCG, Intensive Care Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data can be shared on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Maarten van den Berge', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}