Analysis of COVID-19-related clinical trials registered in the Clinical Trial Registry of India in 2020: A descriptive study

ABSTRACT

Background: COVID-19 caused immense morbidity and mortality worldwide and was declared a pandemic on March 11, 2020, by the World Health Organization. Lack of effective treatments directed researchers to various interventional strategies, such as development of new drugs or vaccines, drug repurposing models, and AYUSH formulations, for prophylaxis and treatment of COVID-19. Aim and Objectives: The information obtained from registered COVID-19 trials for the year 2020, will help to identify the various aspects for therapeutics and types of study designs used for achieving different objectives, so as to guide researchers for similar future projects. Materials and Methods: A descriptive, observational study was conducted on COVID-19-related clinical trials registered in Clinical Trials Registry of India during calendar year 2020. The details were noted in a predesigned pro forma and evaluated. Results: Of the 946 registered trials, majority were single center (82.76%), interventional (50.7%), randomized (73.1%), open-labeled (61.9%), and prospective in nature (96%). Our study revealed that 40.16% trials used modern medicine while 26.53% used AYUSH formulations. The psychological impact of COVID-19 pandemic was studied in 121 trials, of which 118 trials showed negative impact on the mental well-being. Conclusion: Our study provides thorough insight about the on-going research in our country, especially about various drug repurposing strategies and government supported AYUSH interventions. This may act as a foundation for future investigators to identify any lacunae in the current studies, helping them to diversify their objectives accordingly, so as to encourage quality research in our country.