Bird’s eye view of COVID-19 clinical trials being conducted across India

Abstract

Aim: We are in the midst of COVID-19 pandemic, with more than five lakh deaths around the globe. Ever since the pandemic broke, thousands of clinical trials are being carried out to see for a safe and effective drug in various countries. We aim to analyze various interventional clinical trials for COVID-19 infection currently being conducted in India.

Methods: The study data was downloaded on 9^th June 2020 from Clinical Trials Registry-India and ClinicalTrials.gov available in public domain. The keywords used for search were COVID-19, SARS-CoV-2 and India. These studies were analyzed for type of intervention, design, study subjects and endpoints. The categorical variables are expressed as percentages and continuous values are expressed as interquartile range.

Results: A total of 115 studies were analyzed for study parameters. Overall 62% of total trials were randomized, 63% single center and 78% had multiple arms in the study design. Half of the clinical trials were open-label with only 4 studies being double-blind studies. Only two studies included pediatric age group, while the rest of the studies included subjects between 18-75 yrs. Majority of the studies have clinical cure/recovery (36.52 %) as the primary outcome, while only 18.26% looked for virological cure. Among intervention, allopathic drug and biologicals were studied in almost 40 % of the trials, of which (22.22 %) of the studies used anti-malarial drug and plasma therapy. Among studies that used AYUSH medications, Ayurvedic drugs accounted for almost 34% of intervention.

Conclusion: This study gives us a general idea of various interventions tried in the treatment and prevention of COVID-19 infection. As of June 2020 allopathic medicines have the highest share of trials being conducted in India. This preliminary data could act as a catalyst for further appropriate studies to treat and prevent COVID-19 infection.