COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51131

Ambudhar sharma

ambudhar1984@gmail.com

2021-04-08

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Age >18years <br/ >A person with laboratory confirmation of covid -19, irrespective of signs and symptoms, <br/ >Patients with moderate clinical severity(pneumonia with no signs of severe disease) and severe (severe pneumonia and mild ARDS) requiring hospital admission , Consenting to participate for the trial <br/ >

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 three months <br/ >,Coagulopathy , Thrombocytopenia (Platelet count < 100000/ dl), Pregnancy, active breast-feeding , Patient unable to take oral or nasogastric medications <br/ >,Moderate and severe ARDS, renal dysfunction, altered mental status, shock, thrombotic manifestation ,sepsis at presentation

2

Dr Ambudhar Sharma

18

90

India

Moderate disease at enrollment

3: Moderate disease at enrollment

300

Primary <br/ >Progression to any of following <br/ > <br/ >In-hospital mortality ; moderate and severe ARDS ; shock ;Occurrence of thrombotic events(VTE; ACS; ischemic stroke);Cardiac injury (acute heart failure;dysrythmia);Acute kidney injury;Impaired counciousness;Length of hospital stay <br/ >;Length of mechanical ventilation (invasive plus noninvasive) <br/ >Timepoint: 10 days or till hospital discharge whichever is later

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1415, "treatment_name": "Aspirin+atorvastatin+nicorandil", "treatment_type": "Coagulation modifiers+metabolic agents+cardiovascular 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"}]