Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04380402
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2020-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atorvastatin as Adjunctive Therapy in COVID-19
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-05-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death', 'timeFrame': '30 days', 'description': 'Proportion of patients in each arm that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death, as described by WHO Ordinal Scale for Clinical Improvement scores 5-8 with higher being worse.'}], 'secondaryOutcomes': [{'measure': 'Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement', 'timeFrame': '7 days', 'description': 'Description of clinical status of patients in each arm based on WHO Ordinal Scale of Clinical Improvement on Day 7, scores 1-8 with higher being worse.'}, {'measure': 'Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement', 'timeFrame': '30 days', 'description': 'Description of clinical status of patients in each arm based on WHO Ordinal Scale of Clinical Improvement on Day 30, scores 1-8 with higher being worse.'}, {'measure': 'Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7', 'timeFrame': '7 days', 'description': 'Proportions of patients in each arm who are tested on Day 7 and have negative PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '31986257', 'type': 'BACKGROUND', 'citation': 'Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.'}, {'pmid': '30487528', 'type': 'BACKGROUND', 'citation': 'Parihar SP, Guler R, Brombacher F. Statins: a viable candidate for host-directed therapy against infectious diseases. Nat Rev Immunol. 2019 Feb;19(2):104-117. doi: 10.1038/s41577-018-0094-3.'}, {'pmid': '22170954', 'type': 'BACKGROUND', 'citation': 'Vandermeer ML, Thomas AR, Kamimoto L, Reingold A, Gershman K, Meek J, Farley MM, Ryan P, Lynfield R, Baumbach J, Schaffner W, Bennett N, Zansky S. Association between use of statins and mortality among patients hospitalized with laboratory-confirmed influenza virus infections: a multistate study. J Infect Dis. 2012 Jan 1;205(1):13-9. doi: 10.1093/infdis/jir695. Epub 2011 Dec 13.'}, {'pmid': '32219363', 'type': 'BACKGROUND', 'citation': 'Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.'}, {'pmid': '32198163', 'type': 'BACKGROUND', 'citation': 'Fedson DS, Opal SM, Rordam OM. Hiding in Plain Sight: an Approach to Treating Patients with Severe COVID-19 Infection. mBio. 2020 Mar 20;11(2):e00398-20. doi: 10.1128/mBio.00398-20.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/results/NCT02056340?view=results', 'label': 'Statin therapy in acute influenza'}]}, 'descriptionModule': {'briefSummary': 'Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.', 'detailedDescription': 'COVID-19 is caused by SARS-CoV-2, a β-coronavirus that binds to the zinc peptidase angiotensin-converting enzyme 2 (ACE2). No drug is licensed to treat COVID-19, but adjunctive pharmacologic interventions have been proposed for their immunomodulatory effects, including statins. About 5% of cases are considered critical, with severe respiratory failure as well as myocarditis, and thromboses, and are associated with high fatality rate. Statins affect endothelial dysfunction and have anti-inflammatory and immunomodulatory effects.\n\nThis prospective, randomized, open-label trial of atorvastatin as adjunctive treatment of COVID-19 in hospitalized patients aims to study:\n\n1. Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?\n2. Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18-85 years, admitted with suspected COVID-19 disease based on clinical criteria (typical upper respiratory symptoms, e.g. runny nose, sore throat, dry cough, associated with COVID-19 infection).\n\nExclusion Criteria:\n\n* already on chronic statin therapy, known hypersensitivity or adverse events to statins, negative nasopharyngeal (NP) swab for SARS-CoV-2, pregnancy and lactation, need for ICU admission, ALT or AST \\>2X upper limit of normal; CPK \\> 5x upper limit of normal; and creatinine clearance \\<50%, chronic treatment with colchicine, cyclosporin, digoxin, fusidic acid, azole antifungals, niacin.'}, 'identificationModule': {'nctId': 'NCT04380402', 'acronym': 'STATCO19', 'briefTitle': 'Atorvastatin as Adjunctive Therapy in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Mount Auburn Hospital'}, 'officialTitle': 'Prospective Randomized Open-label Trial of Atorvastatin as Adjunctive Treatment of COVID-19', 'orgStudyIdInfo': {'id': 'MountAuburn'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '40 mg', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['atorvastatin calcium'], 'description': 'Atorvastatin 40 mg tablet', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lin Chen, MD', 'role': 'CONTACT', 'email': 'lchen@hms.harvard.edu', 'phone': '617-499-5026'}, {'name': 'Rita Cosgrove', 'role': 'CONTACT', 'email': 'rcosgro1@mah.harvard.edu', 'phone': '617-499-5774'}], 'facility': 'Mount Auburn Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'centralContacts': [{'name': 'Lin H Chen, MD', 'role': 'CONTACT', 'email': 'lchen@mah.harvard.edu', 'phone': '617-499-5026'}, {'name': 'Dan Bourque, MD', 'role': 'CONTACT', 'email': 'dbourque@mah.harvard.edu', 'phone': '617-499-5026'}], 'overallOfficials': [{'name': 'Lin H Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Auburn Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Auburn Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}