Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 2:29 PM
Study NCT ID:
NCT04952350
Status:
UNKNOWN
Last Update Posted:
2021-10-25
First Post:
2021-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin for Reduction of 28-day Mortality in COVID-19: RCT
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'}, {'id': 'D013607', 'term': 'Tablets'}], '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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients, caregivers, data collectors, and data analysts will be blinded for the study group. The Delta Pharma company (Egypt) will provide the atorvastatin and a similar placebo. The company will not participate in any step of the study including participant recruitment, data collection, data analysis, or results reporting. The company will prepare a similar package of drug and placebo (labeled as A and B). Even the pharmacist involved in treatment allocation will not know what is the treatment group, just A or B. For emergency unmasking, one of the directors of the COVID19 research council, who will not participate in the study, will know the true labels and the randomization table.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'C-Reactive Protein', 'timeFrame': 'on days 3, 7, 14, and 28 after randomization/ if still hospitalized', 'description': 'as inflammatory marker'}, {'measure': 'Sequential Organ Failure Assessment scale', 'timeFrame': 'on days 3, 7, 14, and 28 after randomization/ if still hospitalized', 'description': 'SOFA scale'}, {'measure': 'COVID Disease progression score', 'timeFrame': 'on days 3, 7, 14, and 28 after randomization/ if still hospitalized', 'description': 'according to the January 2021 WHO update'}], 'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28 days after randomization', 'description': 'all-cause mortality'}, {'measure': 'mortality', 'timeFrame': '6 months after randomization', 'description': 'all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'incidence of invasive mechanical ventilation (IMV)', 'timeFrame': '28 days or primary hospital stay', 'description': 'incidence'}, {'measure': 'duration of invasive mechanical ventilation (IMV)', 'timeFrame': '28 days or primary hospital stay', 'description': 'duration in days'}, {'measure': 'Time to clinical improvement', 'timeFrame': '28 days or primary hospital stay', 'description': '2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first.'}, {'measure': 'serious adverse effects', 'timeFrame': '28 days after start of the drug', 'description': 'any event that leads to discontinuation of the drug'}, {'measure': 'Intensive Care length of stay', 'timeFrame': '28 days or primary hospital stay', 'description': 'duration in days'}, {'measure': 'acute kidney injury', 'timeFrame': '28 days or primary hospital stay', 'description': 'Increase in Scr by \\>/ 0.3 mg/ dl in 48 hr or Increase in Scr by \\>/ 50% in 7 days or Oliguria for \\>/ 6 hours.'}, {'measure': 'status at hospital discharge', 'timeFrame': 'through study completion, an average of 9 months', 'description': 'dead or alive'}, {'measure': 'Hospital length of stay', 'timeFrame': 'through study completion, an average of 9 months', 'description': 'Length of hospital stay in days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atorvastatin', 'randomized clinical trial'], 'conditions': ['Covid19', 'SARS-CoV2 Infection', 'COVID-19 Pneumonia']}, 'referencesModule': {'references': [{'pmid': '38389078', 'type': 'DERIVED', 'citation': 'Eltahan NH, Elsawy NH, Abdelaaty KM, Elhamaky AS, Hassan AH, Emara MM. Atorvastatin for reduction of 28-day mortality in severe and critical COVID-19 patients: a randomized controlled trial. Respir Res. 2024 Feb 22;25(1):97. doi: 10.1186/s12931-024-02732-2.'}, {'pmid': '35941669', 'type': 'DERIVED', 'citation': 'Emara MM, Elsawy NH, Abdelaaty KM, Elhamaky AS, Eltahan NH. Atorvastatin for reduction of 28-day mortality in hospitalized COVID-19 patients: study protocol for a randomized, double-blinded, placebo-controlled, clinical trial. Trials. 2022 Aug 8;23(1):636. doi: 10.1186/s13063-022-06619-9.'}]}, 'descriptionModule': {'briefSummary': 'This randomized placebo-controlled double-blinded clinical trial aims to test the efficacy of administering atorvastatin 40 mg to hospitalized COVID-19 patients for 28 days on the all-cause 28-day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* We will include adult patients (≥18 years old) with severe and critical COVID19 admitted to the COVID19 Mansoura University isolation hospital. We will include patients who are PCR-confirmed, clinically or radiologically diagnosed with COVID19.\n\nCases are defined as severe or critical according to the WHO definition (19); where critical cases have ARDS, or sepsis, septic shock or pulmonary embolism, acute coronary syndrome, or acute stroke, while severe cases have the clinical signs of severe pneumonia and SpO2 \\<90% on room air, or RR \\<30 breaths/min without any critical criteria.\n\nExclusion Criteria:\n\n* chronic statin use, serum creatine kinase (sr CK) \\> 5 times the upper limit of normal (ULN), serum transaminases \\> 5 times ULN, acute hepatic failure, chronic liver disease (Child-Pugh Classification C), history of rhabdomyolysis or myopathies, severe renal impairment not receiving renal replacement therapy (estimated Cr cl\\< 30 ml\\\\min ), pregnant and lactating women, patients who are expected to die within 48 hours, or patients on chronic colchicine, cyclosporines, or ritonavir.'}, 'identificationModule': {'nctId': 'NCT04952350', 'acronym': 'COVID-STAT', 'briefTitle': 'Atorvastatin for Reduction of 28-day Mortality in COVID-19: RCT', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Atorvastatin in Hospitalized COVID-19 Patients: A Randomized, Double-blinded, Placebo-Controlled, Clinical Trial', 'orgStudyIdInfo': {'id': 'R.21.04.1300.R1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin', 'description': 'All patients will be randomized to receive atorvastatin 40 mg once daily orally for a maximum of 28 days. All patients will receive the standard of care according to recent local hospital protocol. Antiviral treatment will be allowed and will be reported.\n\nAdministration in unconscious or ventilated patients: The patients will receive the drug (divided into 4 quadrants) through a nasogastric tube.', 'interventionNames': ['Drug: Atorvastatin 40 Mg Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'All patients will be randomized to receive the placebo once daily orally for a maximum of 28 days. All patients will receive the standard of care according to recent local hospital protocol. Antiviral treatment will be allowed and will be reported.\n\nAdministration in unconscious or ventilated patients: The patients will receive the drug through a nasogastric tube.\n\nPlacebo will resemble the original drug as regards the drug package, the tablet color, consistency, and size.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Atorvastatin 40 Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['134523-00-5', 'ATORVASTATIN CALCIUM', 'Lipitor'], 'description': 'Patients will receive Atorvastatin 40 mg orally within 24 hrs after hospital admission after evaluation of the clinical and laboratory inclusion criteria.', 'armGroupLabels': ['Atorvastatin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University - Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'will be updtaed shortly', 'ipdSharing': 'YES', 'description': 'We will make the anonymous individual data available at reasonable request after publication. Patient confidentiality will be kept safe.', 'accessCriteria': 'will be updated shortly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}