COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44814

Dr Deepti Siddharthan

deeptikailath@gmail.com

2020-07-25

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1) RT-PCR positive for SARS-CoV-19 infection, <br/ >2)Symptoms (WHO clinical improvement ordinal score 3 to 5) requiring hospital admission, <br/ >3)Consenting to participate for the trial. <br/ >

1) Critical illness with WHO clinical improvement ordinal score >5, <br/ >2) Documented significant liver disease / dysfunction (AST/ALT > 240), <br/ >3) Myopathy and Rhabdomyolysis (CPK > 5x normal), <br/ >4) Allergy or intolerance to statins, <br/ >5) Allergy or intolerance to aspirin, <br/ >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, <br/ >7) Prior statin use (within 30 days), <br/ >8) Prior aspirin use (within 30 days), <br/ >9) History of active GI bleeding in past three months, <br/ >10)Coagulopathy, <br/ >11)Thrombocytopenia (Platelet count < 100000/ dl), <br/ >12)Pregnancy, active breast-feeding, <br/ >13)Patient unable to take oral or nasogastric medications. <br/ >

4

Dr Deepti Siddharthan

40

75

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

800

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

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 129, "treatment_name": "Aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 137, "treatment_name": "Atorvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]