---

Study of clinical trials for the management of COVID-19 outbreak registered in the Clinical Trial Registry-India

---

Original Article

Author Details : Vishal Kumar Biswkarma*, Swati Wadhawan

Volume : 7, Issue : 2, Year : 2020

Article Page : 100-112

https://doi.org/10.18231/j.ijpp.2020.019

Suggest article by email

Get Permission

---

Abstract

Context: After China, now COVID-19 is spreading all over the world in about 212 countries and territories.
In India, over 46008 active, 22454 recovered, 2293 death, and 1 migrated case (a total of 70756 cases) has
been reported till 12th May 2020.
Aims: This study has been designed to review the currently registered clinical studies in Clinical Trials
Registry-India. The study provides the overall summary and insight into diagnostic tools, treatment, and
preventive strategies for COVID-19.
Settings and Design: All the clinical trials (including clinical studies) registered in Clinical Trials
Registry-India between 31 March 2020 to 11th May 2020 were reviewed and analyzed.
Materials and Methods: The registered studies in CTRI (ctri.nic.in) were searched in the “Trial Search”
option with keywords such as “COVID-19”, “Corona Virus”, “SARS-CoV2”, and “2019 nCoV”.
Statistical analysis used: NA.
Results: A total of 57 trials over COVID-19 have been registered in CTRI within the last three months
(i.e. 1st March 2020 to 11th May 2020).
These trials include 40 interventional trials and 17 clinical studies. The interventional studies include the
drug, biologics, ayurvedic, homeopathic, diagnostic, nutritional, and process of care change.
Conclusions: The world is combating against the COVID-19 outbreak. The availability of new health
intervention against COVID-19 needs the more scientific, and collaborative center of attention towards
drug development and clinical trials for COVID-19.
Key Messages: The fast track approval of clinical trials, effective study design, making informed consent
more “inform”, planning and scientific consideration over sample size, development of data safety
monitoring board to supervise and ensure trial participant’s safety may enforce the successfulness of trial
completion.

Keywords: Clinical Trial Registry India, COVID19, Clinical trials, Interventional studies, Observational studies

How to cite : Biswkarma V K , Wadhawan S , Study of clinical trials for the management of COVID-19 outbreak registered in the Clinical Trial Registry-India. Indian J Pharm Pharmacol 2020;7(2):100-112

This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.