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


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Article type :

Original Article

Author :

Vishal Kumar Biswkarma, Swati Wadhawan

Volume :

7

Issue :

2

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.

Keyword :

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