Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Atorvastatin (Statin): Tablet Atorvastatin 40mg once daily for ten days or till discharge whichever is later
Intervention2: Aspirin: Tablet Aspirin 75mg once daily for ten days or till
Sponsors
Dr Deepti Siddharthan
Eligibility
Inclusion criteria
Inclusion criteria: 1) RT-PCR positive for SARS-CoV-19 infection, 2)Symptoms (WHO clinical improvement ordinal score 3 to 5) requiring hospital admission, 3)Consenting to participate for the trial.
Exclusion criteria
Exclusion criteria: 1) Critical illness with WHO clinical improvement ordinal score >5, 2) Documented significant liver disease / dysfunction (AST/ALT > 240), 3) Myopathy and Rhabdomyolysis (CPK > 5x normal), 4) Allergy or intolerance to statins, 5) Allergy or intolerance to aspirin, 6) 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, 7) Prior statin use (within 30 days), 8) Prior aspirin use (within 30 days), 9) History of active GI bleeding in past three months, 10)Coagulopathy, 11)Thrombocytopenia (Platelet count 12)Pregnancy, active breast-feeding, 13)Patient unable to take oral or nasogastric medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).Timepoint: 10 days or until discharge whichever is longer | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum inflammatory markers (ESR, CRP, and IL-6), Trop I, CPK from time zero to 5th day of study enrollment or 7th day after symptom onset, whichever is later.Timepoint: 10 days or until discharge whichever is longer;ICU admissionTimepoint: 10 days or until discharge whichever is longer;In-hospital mortalityTimepoint: 10 days or until discharge whichever is longer;Length of hospital stayTimepoint: 10 days or until discharge whichever is longer;Length of ICU stayTimepoint: 10 days or until discharge whichever is longer;Progression to ARDSTimepoint: 10 days or until discharge whichever is longer;Progression to shockTimepoint: 10 days or until discharge whichever is longer;Safety concerns - like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, bleedings (minor and major), and others (if any). Timepoint: 10 days or until discharge whichever is longer | — |
Countries
India
Contacts
Public ContactDr Deepti Siddharthan
All India Institute of Medical Sciences (AIIMS), New Delhi
Outcome results
None listed