| Methods |
Trial design: RCT, open‐label, phase 2 + 3 Type of publication: preprint Setting: hospital, National Cancer Institute (NCI), Jhajjar, Haryana Recruitment dates: completed Country: India Language: English Number of centres: 1 (single‐centre) Inclusion criteria: age from 40 to 75 years, both genders, RT‐PCR positive for SARS‐CoV‐19 infection, symptoms; WHO clinical improvement ordinal score 3 to 5 requiring hospital admission, consenting to participate in the trial Exclusion criteria: critical illness with WHO clinical improvement ordinal score > 5, documented significant liver disease/dysfunction (AST/ALT > 240), myopathy and rhabdomyolysis (CPK > 5x normal), allergy or intolerance to statins, allergy or intolerance to aspirin, patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine, prior statin use (within 30 days), prior aspirin use (within 30 days), history of active GI bleeding in past 3 months, coagulopathy, thrombocytopenia (platelet count < 100,000/dL), pregnancy, active breastfeeding, patient unable to take oral or nasogastric medications Trial registration number: CTRI/2020/07/026791 Date of trial registration: 25 July 2020 |
| Participants |
Age: 40 to 75 years Gender: 650 male/250 female Ethnicity: NR Number of participants (recruited/allocated/evaluated): 900/900/800 Severity of disease: SARS‐CoV‐2 infection (COVID‐19)‐ WHO Ordinal Scale for Clinical Improvement 3, 4, 5 Additional diagnoses: NR Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR Percentage of positive PCR: 100% (due to inclusion criteria) |
| Interventions |
Intervention: aspirin oral tablet aspirin 75 mg once daily for 10 days or till discharge, whichever is later Intervention: atorvastatin: oral tablet atorvastatin 40 mg once daily for 10 days or till discharge, whichever is later Intervention: aspirin + atorvastatin: oral tablet aspirin 75 mg once daily for 10 days or till discharge, whichever is later, + oral tablet atorvastatin 40 mg once daily for 10 days or till discharge, whichever is later Comparator: conventional therapy for COVID‐19 infected patients
Concomitant therapy: NR
Treatment cross‐overs: NR
Duration of follow‐up: all study participants were followed up for 10 days or until hospital discharge, whichever was later
Treatment cross‐overs: NR
Compliance with assigned treatment: NR |
| Outcomes |
Primary outcomes
Clinical deterioration characterised by progression to WHO clinical improvement ordinal score ≥ 6 (i.e. endotracheal intubation, non‐invasive mechanical ventilation, pressor agents, RRT, ECMO, and mortality)
Secondary outcomes
Change in serum inflammatory markers (ESR, CRP, and IL‐6), Trop I, CPK from time zero to fifth day of study enrolment or seventh day after symptom onset, whichever is later ICU admission In‐hospital mortality Length of hospital stay Length of ICU stay Progression to acute respiratory distress syndrome Progression to shock Safety concerns ‐ e.g. myalgia, myopathy, rhabdomyolysis, hepatotoxicity, bleeding (minor and major) and others (if any)
Additional outcomes: NR |
| Notes |
Sponsor/funding: The TIMI Study Group/no funding source COIs: the authors declare that there is no conflict of interest Other: approved by Institute Ethics Committee |
