Description and Analysis of Characteristics of COVID-19 Clinical Trials Registered in the Clinical Trials Registry-India (CTRI)
E Abinaya
, S Saradha, K. R Ilamathi, A Ruckmani and R Arunkumar*
Department of Pharmacology, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Kelambakkam, Chennai-603103, Tamil Nadu, India.
Corresponding Author E-mail: drarunvp@gmail.com
Abstract:
Introduction: Many clinical trials are ongoing in India to evaluate the efficacy and safety of various interventions in COVID-19. It is mandatory that the clinical trials be registered in the Clinical Trials Registry-India (CTRI) before enrollment of study participants. The present study was carried out with the objective of collecting, compiling and analyzing various types of trial data such as study design, interventions, outcomes and study sites.
Methods: The clinical trial data were collected from the CTRI web portal using the key word “COVID-19” on 14 July 2020. The CTRI data output of every study registered till 14 July 2020 was stored as PDF document and the data were transcribed into a validated excel sheet based on the pre-defined methods and categories and analyzed.
Results and Conclusion: A total of 293 clinical studies have been registered in CTRI as on 14 July 2020. Among them, 188 (64.16%) are interventional and 105 (35.83%) are observational studies. The interventions being evaluated are modern medications including drugs and biologicals, AYUSH formulations, Nutraceuticals, Yoga and Naturopathy. Most of the interventions are already in clinical use for non-COVID indications and undergoing repurposing evaluations for COVID-19 in the clinical studies. Trials with AYUSH formulations constitute more than half of the interventional studies (51.06%) while modern medications in 31.09% of the studies. 119 trials (63.3%) of the interventional studies are randomized studies. Large numbers of trials are conducted in the states where the incidence of COVID-19 is high. 146 interventional studies out of 188 are expected to be completed within 6 months and the outcomes of these studies may provide valid information on the potential treatments in COVID-19.
Keywords: COVID-19; CTRI; Clinical Trials; SARS Cov2 Back to TOC