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Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry

Angelika Batta1, Raj Khirasaria2, Vinod Kapoor1

  • 1Department of Pharmacology, Faculty of Medical & Health Sciences, SGT Medical College, Hospital and Research Institute, SGT University, Gurugram, Haryana, India.

Journal of Basic and Clinical Physiology and Pharmacology
|February 12, 2021
PubMed
Abstract

Insights

Clinical trials in India for COVID-19 show a fair number of therapeutic interventions, with AYUSH-based treatments being most common. Further improvements in trial quality and quantity are needed, alongside exploring drug repurposing for faster decisions.

Area of Science:

  • Clinical Research
  • Public Health
  • Pharmacology

Background:

  • The COVID-19 pandemic necessitated rapid development of preventive and therapeutic options.
  • Clinical trials are crucial for evaluating treatment efficacy and safety.

Purpose of the Study:

  • To analyze therapeutic interventional clinical trials registered in India for COVID-19.
  • To provide insights into the landscape of COVID-19 clinical trials in India.

Main Methods:

  • Searched the Clinical Trial Registry of India (CTRI) for trials using the keyword "COVID" until June 9, 2020.
  • Filtered for therapeutic interventional studies and collected data on intervention type, treatment, centers, institution type, study design, and sponsors.
  • Analyzed data using Microsoft Office Excel 2007.

Main Results:

  • 127 interventional trials were identified, with 71 (56%) involving AYUSH interventions, 36 (28.3%) testing drugs, and 66 (56%) being therapeutic.
  • The majority of trials were single-centered (73.7%), government-funded (48.3%), and randomized controlled trials (56.8%).
  • Examples of AYUSH interventions included AYUSH-64, Arsenic Album, and SamshamaniVati.

Conclusions:

  • India demonstrated a reasonable number of therapeutic interventional trials for COVID-19.
  • There is a need to enhance both the quantity and quality of clinical trials for COVID-19.
  • Drug repurposing across different medical systems offers a cost-effective approach for prompt clinical decisions compared to de novo drug development.
Keywords:
AYUSHCOVID-19CTRIIndiaclinical trialscorona virustherapeutic interventions

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