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Recruitment for HCQ Solidarity Trial Stopped in India

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June 19, 2020

Medical institutions in India will stop recruiting candidates for testing hydroxychloroquine as part of the Solidarity Trial of the World Health Organization, which halted testing of the drug after finding no benefit for severely ill Covid-19 patients.

The decision to scrap HCQ testing was based on evidence from the Solidarity Trial, the UK’s Recovery Trial and a Cochrane review of other evidence, WHO said in a statement. WHO’s own data showed HCQ did not reduce mortality of hospitalised Covid-19 patients compared with the standard of care.

“Investigators will not randomise further patients to hydroxychloroquine in the Solidarity Trial. Patients who have already started hydroxychloroquine but who have not yet finished their course in the trial may complete their course or stop at the discretion of the supervising physician,” WHO said.

Over 15 countries are participating in the Solidarity Trial of five drugs for treatment of Covid-19, with 7,000 patients enrolled. In India, 1,500 patients were enrolled by 24 medical institutions. The other drugs under consideration are Remdesivir; Lopinavir/Ritonavir; and Lopinavir/Ritonavir with Interferon beta-1a.

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Trial investigators told ET that when one arm of the testing is dropped because of lack of efficacy or harm, countries can go back to their ‘standard of care’ protocol. In India, HCQ continues to be the standard of care in several hospitals.

“Until ICMR (Indian Council of Medical Research) changes the national guideline, physicians may or may not decide to stop prescribing the drug,” said Rajneesh Joshi of All India Institute of Medical Sciences in Bhopal, one of the Solidarity Trial investigators.

Last week, the US Food and Drug Administration removed HCQ from its emergency use guidelines for Covid-19 treatment. “The USF DA and WHO halt of HCQ trial is the final nail for the drug in terms of Covid-19 treatment — time for ICMR to also change its guidelines,” said a physician who is part of the health ministry’s Covid-19 management team.

An ICMR spokesperson did not respond to a text sent by ET seeking comment on the matter.

Source: ET HealthWorld

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