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Tuesday, July 07, 2020

After WHO move, 22 trial sites in India to stop HCQ research

The HCQ arm will be removed from the online randomisation software, it was informed. So investigators cannot randomise further patients to HCQ in the Solidarity trial.

Written by Anuradha Mascarenhas | Pune | Updated: June 19, 2020 8:07:44 am
coronavirus latest news, hydroxychloroquine, chloroquine, coronavirus treatment, who Dr Reddy told The Indian Express that an amended protocol would be circulated soon. (AP)

Twenty-two trial sites in the country will stop the hydroxychloroquine (HCQ) arm of the Solidarity Trial to find an effective Covid-19 treatment following the WHO’s announcement that the drug was futile in reducing mortality in hospitalized coronavirus patients.

“The results confirm with high a degree of confidence that hydroxychloroquine is not effective at reducing mortality in hospitalised Covid-19 patients,” the executive group of the steering committee of the Solidarity Trial, chaired by John-Arne Røttingen, has said.

Dr Srinath Reddy, of the executive group, along with WHO chief scientist Dr Soumya Swaminathan, are among the members.

Dr Reddy told The Indian Express that an amended protocol would be circulated soon.

More than 3,500 patients had been enrolled from 21 countries, including India, for the trial. Dr Sheela Godbole, head, Division of Epidemiology, ICMR-National AIDS Research Institute (NARI), and national coordinator of the Solidarity Trial in the country, told The Indian Express that 22 clinical trial sites had been approved and more than 300 participants had been randomised.

Dr Samiran Panda, director of NARI, also said HCQ was found to be ineffective in hospitalised Covid-19 patients but since it was an adaptive trial there is an opportunity to contribute to other key public health questions that have not yet been reliably answered. “We have issued instructions about stopping the HCQ arm of the trial to coordinators at trial sites. However, the decision to continue HCQ for patients who have been started on it can be taken by the supervising physician,” Dr Godbole explained.

According to the letter sent by the executive group to national coordinators of the Solidarity Trial, Remdesivir and Interferon beta-1a are the two study drugs which Solidarity Trial is best placed to evaluate definitively for possible effects on mortality, and also decided that the Lopinavir/ritonavir arms will be discontinued. This was because the UK Recovery trial, given its current size, will assess Lopinavir/ritonavir robustly without additional recruitment into Solidarity, the letter stated.

The executive group met on June 10 and 12 to discuss a review of interim analyses of HCQ versus standard of care data from the Solidarity/Discovery trials, and a pooled analysis conducted including UK Recovery trial data and subsequent decisions for continuation with the Solidarity Trial and its associated add-on studies. After careful consideration, it confirmed that the HCQ arm of Solidarity will be stopped due to futility.

The HCQ arm will be removed from the online randomisation software, it was informed. So investigators cannot randomise further patients to HCQ in the Solidarity trial.

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