Indian Clinical Trials on COVID-19: A Review of Clinical Trials Registry of India (CTRI) (Preprint)

BACKGROUND The COVID-19 has impacted the world in an unprecedented way. More than 200 countries have been affected because of this novel coronavirus. Global public health, economy and society have all faced near breakdown. There is a surge for identifying vaccine or repurposing existing drugs for this virus. OBJECTIVE An attempt has been made to provide a comprehensive overview on clinical trials that are being conducted in India on COVID-19. Type of clinical trials, study designs, DCGI approval status of trials, allopathic and Ayurvedic interventions and other characteristics of COVID-19 clinical trials have been analyzed in this study METHODS Clinical Trials Registry of India (CTRI) was used as the data source for the study. COVID-19 Clinical trials registered up to 14th July 2020 was collected using following keywords “SARS-CoV-2, Novel Coronavirus or Corona Virus, or Coronavirus and COVID or COVID-19. After excluding repeated or trials registered by non-Indian countries 312 clinical trials were considered for the final analysis. RESULTS Interventional studies were more compared to observations studies, most of the clinical trials were investigating AYUSH related interventions as an effective therapeutics compared evidence based allopathic interventional drugs or medicines. There were six vaccine candidates under clinical trials in India. Four trials were examining the safety and efficacy of BCG as a potential vaccine for COVID-19. Of the 312 trials 12.50% of the trials have obtained DCGI approval. Most of the studies were phase 2 & 3 trials, 82% trials were yet to start recruiting participants for their clinical trials. CONCLUSIONS This study provides a detailed overview of ongoing Indian clinical trials on COVID-19. This study is useful for researchers, policymakers for prioritizing research on COVID-19 and for general public to understand and aware about the Indian efforts in clinical research on COVID-19.