Trial CTRI/2020/07/026791
Publication Ghati N, Removed from SSRN (preprint)
Dates: 7/28/2020 to 1/27/2021
Funding: No specific funding
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / India Follow-up duration (days): 10 | |
| Inclusion criteria | - All RT-PCR positive Covid-19 patients, - ⥠40 years and < 75 years of age, - Requiring hospitalisation due to symptoms [World Health Organization (WHO) Ordinal Scale for Clinical Improvement 3 to 5] |
| Exclusion criteria | - Patients with critical illness (WHO Ordinal Scale for Clinical Improvement > 5), - documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240 IU/L), - myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), - known allergy or intolerance to statins or aspirin, - prior statin or aspirin use in last 30 days, - history of active gastrointestinal bleeding in past three months, - coagulopathy, - thrombocytopenia (platelet count < 100000/ dL), - pregnancy, active breastfeeding, - inability to take oral or nasogastric medications - patients refusing consent - taking medicines known to have a significant drug interaction with statin or aspirin [including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine] |
| Interventions | |
| Treatment 1 Atorvastatin | |
| Control Standard care | |
| Control Aspirin | |
| Control Atorvastatin+Aspirin | |
| Participants | |
| Randomized 900 participants n1=224/ n2=226/ n3=225/ n4=225/ | |
| Characteristics of participants N=900 Mean age : 53.1 650 males Severity : Mild: n=724 / Moderate: n=133/ Severe: n=25 Critical: n=0 | |
| Primary outcome | |
| In the register Clinical deterioration characterised by progression to WHO clinical improvement ordinal score more than or equal to 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, RRT, ECMO, and mortality) | |
| In the report Clinical deterioration to WHO Ordinal Scale for Clinical Improvement ≥ 6 [i.e., endotracheal intubation, pressor agents, renal replacement therapy, extra corporeal membrane oxygenator (ECMO) requirement, and mortality] | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. There is no change from the trial registration in the intervention and control treatments, as well as in primary and secondary outcomes. The registry primary outcome does reflect the reported primary outcome. The study data were extracted from the study reports intially posted on SSRN, the |