Characterisation of current pharmacotherapeutic COVID-19 clinical trials in India: A registry-based descriptive analysis

Abstract

COVID-19 has emerged as a global pandemic. There is currently a spurt of clinical research to generate evidence to treat this novel disease. The aim of the current study is to characterise the pharmacotherapeutic intervention-related clinical trials registered in India. COVID-19 clinical trials registered in India were analysed from data retrieved from Clinical Trial Registry-India, ClinicalTrials.gov and International Clinical Trial Registry Platform. Parameters such as study design, sample size, pharmacotherapeutic interventions and primary outcomes were evaluated. A total of 267 studies were screened among which 103 clinical trials were assessed for descriptive analysis. Majority of registered trials (55.3%) were in Indian System of Medicine followed by antimalarials such as hydroxychloroquine/chloroquine (10.5%) and plasma therapy (7.1%). Most commonly used study design was randomised parallel group in 63%. Open-label study was seen in 47.5%. Primary outcome was improvement of clinical symptoms in 46.6% followed by rate and time of viral load reduction in 18.2%. Maharashtra (n = 35) followed by Delhi (n = 29) had the maximum number of registered trial sites. The study gives broad perspective on the current trend of clinical trials on COVID-19 being conducted in India. The outcomes of these trials will lead to generation of valuable data for evidence-based treatment of COVID-19.