study to access effectiveness of new drug therapy (aspirin,atorvastatin and nicorandil) in covid-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B338- Other specified viral diseases
- Registration Number
- CTRI/2021/04/032648
- Lead Sponsor
- Dr Ambudhar Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Age >18years
A person with laboratory confirmation of covid -19, irrespective of signs and symptoms,
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
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
,Coagulopathy , Thrombocytopenia (Platelet count < 100000/ dl), Pregnancy, active breast-feeding , Patient unable to take oral or nasogastric medications
,Moderate and severe ARDS, renal dysfunction, altered mental status, shock, thrombotic manifestation ,sepsis at presentation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary <br/ ><br>Progression to any of following <br/ ><br> <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/ ><br>,Length of mechanical ventilation (invasive plus noninvasive) <br/ ><br>Timepoint: 10 days or till hospital discharge whichever is later
- Secondary Outcome Measures
Name Time Method Secondary <br/ ><br>Change in serum markers (CRP, D â??dimer, S ferritin). <br/ ><br> <br/ ><br>Individual occurrence of any of following <br/ ><br> <br/ ><br>In-hospital mortality <br/ ><br>Progression to mod or severe ARDS ,Progression to shock ,Occurrence of thrombotic events(VTE, ACS, ischemic stroke),Cardiac injury (acute heart failure,dysrythmia) <br/ ><br>,Acute kidney injury,Impaired counciousness <br/ ><br>Timepoint: 10 days or till hospital discharge whichever is later