Published: Sat, October 17, 2020
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World Health Organization study finds remdesivir didn't help COVID-19 patients

World Health Organization study finds remdesivir didn't help COVID-19 patients

After finding that hydroxychloroquine had no positive effects on COVID-19 infected patients, The WHO, FDA, Oxford University and other countries pulled the plug on their ongoing trials.

Drug regimens containing remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon have "little or no effect" on the 28-day mortality or the course of illness in hospitalised Covid-19 patients, the World Health Organization said on Friday, announcing the interim results of the global trial.

The results do not negate the previous ones, and the WHO study was not as rigorous as the earlier one led by the US National Institutes of Health. "The drug is only part of it".

A South African medical expert said more drug therapies should be investigated for the treatment of COVID19.

Remdesivir is now recommended as first-line treatment in NIH clinical guidelines for hospitalized COVID-19 patients who require supplemental oxygen. In one large controlled trial in the USA, the drug was found to have shortened recovery time by about a third in severely ill, hospitalised adults with COVID-19, but of little to help those with milder cases.

Interestingly, WHO investigators noted the previous research on remdesivir, including ACTT-1 from the NIH, and two smaller trials.

"The main outcomes of mortality, initiation of ventilation and hospitalisation duration were not clearly reduced by any study drug", wrote the authors of a preliminary paper on the findings, released on the preprint website medRxiv Thursday.

Because of its design, there was "significant heterogeneity" in the way the trial was conducted. More research is needed, the authors say, but for now, they conclude, they have "identified important molecular mechanisms and potential drug treatments that merit further ... study".

The antiviral has become part of the standard of care for COVID-19 patients in the United States and has been administered to thousands of patients since its approval, including President Donald Trump after his diagnosis with COVID-19 this month.

Although originally cleared only for use in people who were sick enough to need supplemental oxygen or breathing support, remdesivir's emergency authorization was expanded in August to include all hospitalized patients, regardless of disease severity.

Notably, experts raised pertinent questions after WHO's findings.

The worldwide research found no evidence that several treatments, including the promising antiviral drug remdesivir, had any real effect on patients' odds of survival or other outcomes. The participants were given four drugs singly or in combination: remdesivir, hydroxychloroquine, lopinavir, interferon or interferon plus lopinavir. The trial stopped using hydroxychloroquine and lopinavir in June. Less data has been published on interferon, a molecule produced by the immune system in response to viruses.

World Health Organization investigators also found that no study drug reduced initiation of ventilation in those not already ventilated (295 with remdesivir vs 284 for controls), and found "a lack of material difference" in proportion of patients still hospitalized at day 7 (69% with remdesivir vs 59% for controls). Under an agreement with the manufacturers, Gilead was entitled to see the results 10 days before the manuscript was submitted, Soumya Swaminathan, the WHO's chief scientist, said in the briefing.

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