After `temporary pause`, World Health Organization to resume hydroxychloroquine trials

Grant Boone
June 4, 2020

No serious side effects, such as heart complications, were reported.

"Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention", The Lancet said Tuesday.

The study said it had failed to find any benefit of HCQ or CQ (chloroquine, which too is anti-malarial) in Covid treatment.

Hydroxychloroquine and a similar drug, chloroquine, have been the subject of much debate since Trump started promoting them in March.

The WHO's clinical trials were suspended pending a safety review in the search for coronavirus treatments.

Researchers found "hydroxychloroquine did not prevent illness compatible with COVID-19 or confirmed infection when used as postexposure prophylaxis within four days after exposure".

Researchers looked at 821 people who were exposed to the virus either through their line of worker as a healthcare professional, or from someone at home. Neither they nor others involved in the research knew who was getting which pills.

'There's basically no effect.

"The results are more provocative than definitive, suggesting that the potential prevention benefits of hydroxychloroquine remain to be determined", he wrote. Nausea, loose stools, and abdominal discomfort were the most common side effects.

But until doctors have the results of rigorous trials that randomly assign hospitalized patients to receive hydroxychloroquine or placebo-like the ones now conducted under the guidance of the NIH and WHO-are completed, they won't know for sure if that's the case.

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Study limitations noted by the authors are the lack of availability of diagnostic testing for COVID-19 in the USA, which the healthcare workers were unable to access, meaning a prior symptomatic case definition was used, or a US clinical case definition of probable COVID-19. And not all took their medicines as directed.

The absolute difference of about 2.4 percentage points in favor of the medicine was not considered statistically significant given the sample size, meaning it could have occurred because of chance.

Others were glad to see a study that had a comparison group and good scientific methods after so many weaker reports on hydroxychloroquine.

"This fits with everything else we've seen so far which suggests that it's not beneficial", said Dr. Peter Bach, director of a health policy center at Memorial Sloan Kettering Cancer Center in NY. But while he said that the safety results are encouraging, he anxious that the study, because of size and other limitations, might not completely rule out such issues.

The study was mostly funded by David Baszucki, founder of Roblox, a California-based game software company, and other private donors and the Minnesota university.

France was among the countries to also halt COVID-19 treatment with hydroxychloroquine. The study is finished and results are being analyzed now.

In fact, a day after World Health Organization had suspended the HCQ segment, India had reiterated its faith in the continued prophylactic use of HCQ for Covid saying there was enough experience and sufficient data from observational and case control studies to warrant its use.

The study is the first randomized clinical trial that tested the antimalarial drug, touted by President Donald Trump, as a preventive measure.

Tedros said the executive group behind WHO's global "Solidarity" trial met on Saturday and chose to conduct a comprehensive review of all available data on hydroxychloroquine and that its use in the trial would be suspended for now.

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