New Delhi: The interim results of the joint research programme Solidarity Therapeutics Trial held in India by the Indian Council of Medical Research (ICMR) and the World Health Organization (WHO), were announced on Friday by Prof. (Dr) Balram Bhargava, Director General, Indian Council of Medical Research, and Secretary, Department of Health Research, Government of India.
Speaking on the subject, Dr. Bhargava said, “The trial tested four repurposed drugs: Remdesivir (donated by Gilead, and Hetero Drugs in India), Interferon β1a (donated by Merck), Lopinavir/Ritonavir and Hydroxychloroquine (both locally sourced). The interim results show that no study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics) or initiation of ventilation in hospitalized COVID19 patients.”
He also went on to acknowledge the efforts of all those involved in the trial for generating conclusive evidence in record time. “I congratulate all Indian investigators and their teams for the progress achieved in the Solidarity Therapeutics Trial so far,” said Prof. Bhargava. “ICMR has shown that large randomized controlled national trials are possible, even during a pandemic, to reliably answer critical public health questions concerning therapeutics.” He also cited the example of the PLACID trial for convalescent plasma conducted by ICMR earlier this year, as another example of ICMR’s contributions to the science of COVID 19 therapeutics.
“This was truly a well-coordinated national effort, led by ICMR-National AIDS Research Institute (NARI), Pune, with Dr. Sheela Godbole, Scientist F, at the helm. The trial comprised 26 actively randomizing sites with 937 participants as of 15 October 2020 in India. We are grateful to the trial participants and their families for contributing to these crucial findings,” said Dr Samiran Panda, Head, ICMR-Division of Epidemiology and Communicable Diseases, and Director, ICMR-NARI. “The results are under review for publication. A preprint is available at medRxiv and includes not only the trial data, but also a combined analysis with data from other trials, which adds confidence to the results.”
Based on the interim results, the Interferon β1a arm of the trial has now been discontinued. In order to increase the precision of the findings, the trial plans to continue randomization of Remdesivir. However, it is likely that the search for a highly efficacious treatment option will have to continue. New options like immunomodulators and monoclonal antibodies may soon be tested under this trial platform globally.
The Solidarity Trial is the world’s largest global randomized controlled trial in a pandemic situation for COVID -19 therapeutics, spanning 30 countries with over 12000 randomizations. India was the twelfth country to join this trial in April 2020.
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