WHO to resume hydroxychloroquine arm of Solidarity Trial

The World Health Organization on Wednesday said that clinical trials of the repurposed anti-malaria drug hydroxychloroquine for treatment of covid-19 will resume, after a committee reviewed the available data for the drug.
“On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol… The Executive Group received this recommendation and endorsed continuation of all arms of the Solidarity Trial, including hydroxychloroquine,” WHO director general Tedros Adhanom Ghebreyesus said at a virtual news briefing.

Ghebreyesus said that the Data Safety and Monitoring Committee, which had reviewed the data, will continue to closely monitor the safety of all therapeutics being tested in the Solidarity Trial.

So far, more than 3500 patients have been recruited for the mega trial in 35 countries, he said.

Apart from hydroxychloroquine, Gilead Sciences Inc’s novel drug remdesivir, a combination of lopinarvir and ritonavir, as well as the anti-cancer combination with interferon are currently being testing in the global Solidarity Trial for repurposing existing drugs for treatment of the new respiratory disease.

The WHO’s decision comes hours after The Lancet Journal issued an ‘expression of concern’ about an observational study that showed risk from the anti-malaria drug in treating covid-19 patients.

Lancet’s ‘expression of concern’, which is a means to alert readers about the integrity of a paper, followed several scientific questions being raised about the data for 96,000 patients that was reported in the paper by its author Mandeep Mehra.

The study was the reason why the WHO had last week halted the hydroxychloroquine arm of the Solidarity Trial.

Hydroxychloroquine and its older form, chloroquine, are widely used in India for treatment of malaria, which prompted the Indian Council of Medical Research to defend its use amid safety concern. The ICMR has been providing a weekly dose of hydroxychloroquine to healthcare workers as prophylaxis, meaning use of the drug to prevent an infection rather than cure it.

Indian pharmaceutical companies, especially Ipca Laboratories and Zydus Cadila Ltd, are two of the world’s largest manufacturers of hydroxychloroquine, and the hype surrounding the repurposed anti-malaria drug had led the two companies to scale up production to allow for sufficient inventories for both the domestic market and exports. – Livemint