COVID-19: World Health Organization retracts order, allows Hydroxychloroquine trials to resume

Henrietta Strickland
June 3, 2020

"We conducted an worldwide, randomized controlled trial to look at whether the use of hydroxychloroquine in patients who'd had a high-risk exposure to COVID-19 would prevent the development of symptomatic disease compared to placebo", Lee said in an interview.

Shortly after its publication, the World Health Organization suspended the use of hydroxychloroquine in a large global trial testing therapies for the disease, and France banned it as a treatment for covid-19.

The drug hydroxychloroquine, which has been the subject of heated debate as a potential treatment for COVID-19, was not effective in preventing the disease in Canadians and Americans at high risk, according to the first gold standard clinical trial.

The Solidarity trial includes participants and researchers in Canada.

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.

While The Lancet corrected a discrepancy in data from Australia, the authors on Friday said they stood by their findings and announced an independent review.

He added, however, that decisions to halt clinical trials on the basis of an observational study were "completely unjustified".

"We found that there was no statistical difference between patients who got the placebo - which was a vitamin pill - versus those who received the active drug hydroxychloroquine", Lee said.

Medication side-effects such as nausea and abdominal discomfort were more common for patients taking hydroxychloroquine compared to placebo (40 per cent versus 17 per cent), but no serious treatment-related adverse reactions were reported, including any heart arrhythmia.

US President Donald Trump has been criticised for promoting the drugs - which are used to treat malaria, arthritis and lupus - as a cure for the new virus.

David Boulware, an infectious disease specialist at the University of Minnesota and senior investigator of the study, said he launched the trial because hydroxychloroquine had shown activity in a lab setting against the coronavirus.

So far, more than 3500 patients have been recruited for the mega trial in 35 countries, he said. Within four days of exposure, each received a delivery from a courier of a package containing either placebo or hydroxychloroquine.

Out of 821 participants, 107 developed COVID-19 - confirmed either by a test or by compatible symptoms - during the 14 days of followup. Both confirmed cases and probable cases - those not tested but judged on symptoms - were included in the study, due to some lack of availability of diagnostic testing in the United States. There was no benefit for people who also took zinc or vitamin C, the researchers said.

Other reports by Click Lancashire

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