| Study name |
A Randomized Open‐Label Trial To Evaluate The Efficacy And Safety Of Triple Therapy With aspirin, Atorvastatin, And Nicorandil In Hospitalised Patients With SARS Cov‐2 Infection: A Structured Summary Of A Study Protocol For A Randomized Controlled Trial |
| Methods |
Trial design: single‐centre, prospective, two‐arm parallel design, open‐label randomised control superiority trial Type of publication: trial registry Setting: hospital Recruitment dates: 21 May 2021 Country: India Language: English Number of centres: single‐centre Inclusion criteria: SARS‐CoV‐2 RT‐PCR/RAT positive with pneumonia, without ARDS at presentation (presence of clinical features of dyspnoea, hypoxia, fever, cough, SpO2 < 94% room air and respiratory rate > 24/minute), hospital admission Exclusion criteria: liver disease/dysfunction (AST/ALT > 240), myopathy and rhabdomyolysis (CPK > 5x normal), allergy or intolerance to statins, allergy or intolerance to aspirin, patient taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole, antifungals (itraconazole, ketoconazole) clarithromycin, colchicine, prior statin use (within 30 days), prior aspirin use (within 30 days), history of active GI bleeding in past 3 months, coagulopathy, thrombocytopenia (platelet count < 100,000/dL), pregnancy, active breastfeeding, patient unable to take oral or nasogastric medications, altered mental status, shock at presentation, acute renal failure, acute coronary syndrome, sepsis, ARDS Date of trial registration: 8 April 2021 Prospective completion date: NR |
| Participants |
Age: > 18 Gender: NR Ethnicity: NR Number of participants (recruited/allocated/evaluated): 396/NR/NR Severity of disease: SARS‐CoV‐2 infection (COVID‐19) and requiring hospitalisation Additional diagnoses: pneumonia Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): symptomatic treatment with antipyretics, adequate hydration, anticoagulation with low molecular weight heparin, intravenous remdesivir, corticosteroids, oxygen support; treatment for comorbid conditions as per guidelines |
| Interventions |
Intervention (triple therapy): aspirin 325 mg starting dose, followed by 75 mg once daily for 10 days or till hospital discharge; atorvastation 40 mg once daily for 10 days or till hospital discharge; nicorandil 10 mg starting dose; followed by 5 mg twice daily for 10 days or till hospital discharge, standard care for COVID management as per national guidelines, symptomatic treatment (with antipyretics, adequate hydration, anticoagulation with low molecular weight heparin, intravenous remdesivir, corticosteroids, oxygen support Control: standard care, symptomatic treatment
Concomitant therapy: symptomatic treatment Treatment cross‐overs: NR Duration of follow‐up: during the hospital stay or for 10 days, whichever is longer Compliance with assigned treatment: NR
|
| Outcomes |
Primary outcomes
In‐hospital mortality
Secondary outcomes
Any progression to ARDS Shock Acute kidney injury Impaired consciousness Length of hospital stay Length of mechanical ventilation (invasive plus non‐invasive)
Additional outcomes: NR |
| Starting date |
8 April 2021 |
| Contact information |
Ambudhar Sharma, 9418048268, moc.liamg@414rahdubma
Charu Sharma, moc.liamg@4891rahdubma
Sujeet Raina, moc.liamg@aniarteejus |
| Notes |
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