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

AbstractObjectivesThe pathophysiology of SARS-Cov-2 is characterized by inflammation, immune dysregulation, coagulopathy, and endothelial dysfunction. No single therapeutic agent can target all these pathophysiologic substrates. Moreover, the current therapies are not fully effective in reducing mortality in moderate and severe disease. Hence, we aim to evaluate the combination of drugs (aspirin, atorvastatin, and nicorandil) with anti-inflammatory, antithrombotic, immunomodulatory, and vasodilator properties as adjuvant therapy in covid- 19.Trial designSingle-centre, prospective, two-arm parallel design, open-label randomized control superiority trial.ParticipantsThe study will be conducted at the covid centre of Dr. Rajendra Prasad Government Medical College Tanda Kangra, Himachal Pradesh, India.All SARS-CoV-2 infected patients requiring admission to the study centre will be screened for the trial. All patients>18years who are RT-PCR/RAT positive for SARS-CoV-2 infection with pneumonia but without ARDS at presentation (presence of clinical features of dyspnoea hypoxia, fever, cough, spo2<94% on room air and respiratory rate>24/minute) requiring hospital admission and consenting to participate in the trial will be included.Patients with 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 medications with significant i...
Source: Trials - Category: Research Source Type: clinical trials