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study to access effectiveness of new drug therapy (aspirin,atorvastatin and nicorandil) in covid-19

To evaluate the efficacy and safety of triple therapy with nicorandil, aspirin and atorvastatin in patients with SARS-CoV -2 infection: randomized controlled trial (NAAC trial)â?? - NAAC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032648
Enrollment
300
Registered
2021-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B338- Other specified viral diseases

Interventions

Intervention1: ASPIRIN, ATORVASTATIN, NICORANDIL: all drugs will be given orally ASPIRIN 325 mg stat f/b 75 mg od atorvastatin 80 mg stat f/b 40 mg od hs nicorandil 10 mg stat f/b 5 mg bd for 10 da

Sponsors

Dr Ambudhar Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 ,Moderate and severe ARDS, renal dysfunction, altered mental status, shock, thrombotic manifestation ,sepsis at presentation

Design outcomes

Primary

MeasureTime frame
Primary Progression to any of following 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 ,Length of mechanical ventilation (invasive plus noninvasive) Timepoint: 10 days or till hospital discharge whichever is later

Secondary

MeasureTime frame
Secondary Change in serum markers (CRP, D â??dimer, S ferritin). Individual occurrence of any of following In-hospital mortality Progression to mod or severe ARDS ,Progression to shock ,Occurrence of thrombotic events(VTE, ACS, ischemic stroke),Cardiac injury (acute heart failure,dysrythmia) ,Acute kidney injury,Impaired counciousness Timepoint: 10 days or till hospital discharge whichever is later

Countries

India

Contacts

Public ContactAmbudhar sharma

Dr. RPGMCTanda

ambudhar1984@gmail.com09418048268

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 22, 2026