Current status of clinical research in Covid-19 vaccines: A registry based audit

Abstract

The COVID-19 or Coronavirus has impacted the world in an unprecedented way. More than 200 countries have been affected because of this novel corona virus. There is a surge for identifying vaccine or repurposing existing drugs for this virus. The rapid spread has globally become a serious issue.The objective of the study was to  provide a comprehensive overview on clinical trials that are being conducted in India and globally on vaccines for COVID-19. This is an observational study.All the clinical studies conducted in the field of vaccines registered on the ClinicalTrials.gov website and Clinical Trial Registry of India (CTRI) up to March 2021 were reviewed and analysed. The variables such as types of trials, study design, status of study whether ongoing or completed, type of intervention tested, sample size of trials,phases of trials were recorded. The data were analysed using descriptive statistics using SPSS 16.0.Out of all the studies registered, 263 were related to vaccine clinical trials among which 201 were interventional and 62 were observational. Out of 201 interventional studies,75.62% were randomised trials.Out of 62 observational studies,53.22% were cohort studies,20.96% were case control studies, 9.67% were cross sectional studies. Pure biologicals constituted 56.65% of the total interventions. Majority of the trials(23.88%) were in phase 1 and phase 3 respectively.3.8% trials have been completed, 44.48% trials are open for recruitment.2 trials have been suspended and withdrawn and 1 trial has been terminated.This study is helpful for researchers, policy makers, and general public for understanding COVID-19 clinical trials eco-system.It will also be useful for global scientific community to know what clinical trials are being conducted on COVID-19 vaccines and potential source of information for international collaborations.