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It’s the end of road for hydroxychloroquine in COVID-19 as Novartis, NIH and WHO pull out of trials

June 23, 2020
Life sciences

The road for hydroxychloroquine against COVID-19 is coming to an end. Three major clinical programs have been terminated after a U.K. trial found “no clinical benefit” for the malaria drug championed by U.S. President Donald Trump.

In the past few days, the World Health Organization (WHO), generic hydroxychloroquine (HCQ) maker Novartis and the U.S. National Institutes of Health (NIH) have all ended their HCQ COVID-19 studies in hospitalized patients in quick succession.

The WHO and NIH cited lack of benefits for patients, while Novartis blamed “acute enrollment challenges.”

Numerous investigator-sponsored trials may still be underway, but none of them has the scale of these three to yield any convincing results. Sanofi previously put a temporary halt to its own study based on safety concerns but has not since resumed recruitment, meaning the latest three terminations were likely the final judgement for HCQ’s use in COVID-19.

China first included HCQ in its COVID-19 treatment guidelines, but it was Trump who promoted the med to global attention after labeling it a “game changer.” Clinical trials were launched to prove its efficacy, and the FDA quickly doled out an emergency use authorization.

But several relatively small clinical trials, including an early one from China and a U.S. Department of Veterans Affairs study, have failed to find the drug’s worth. Its potential risk for serious side effects didn’t build confidence, either.

A controversial study in The Lancet previously led to a temporary halt of the HCQ arm in the WHO Solidarity trial, though it was soon resumed once the paper was found to be based on a dubious source of registry data and therefore was retracted by the authors.

Nevertheless, hope was still alive that a large, well-designed clinical trial would prove otherwise—until now.

Things took a rapid turn in early June. Researchers at the University of Oxford and the U.K. National Health Service said they stopped enrolling patients to the HCQ arm of a large, randomized U.K. trial dubbed Recovery after an independent data monitoring committee found “no beneficial effect” of HCQ in hospitalized patients. Specifically, the 28-day death rate for 1,542 patients who got HCQ was similar to that observed in 3,132 people on standard of care. HCQ treatment also didn’t lead to improvements in hospital stay duration or other clinical outcomes, the team said (PDF).

Days after that announcement, the FDA changed its mind and revoked HCQ’s emergency authorization. The agency based its decision on existing data, including on HCQ’s viral shedding improvement ability and those from the Recovery trial.

The WHO followed suit Wednesday by ending its HCQ study, citing its own observations and findings from the U.K. trial.

Friday, Novartis said it would discontinue its sponsored HCQ trial for COVID-19. “The recruitment challenge facing our HCQ trial has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating patients with COVID-19,” the Swiss drugmaker said in a statement.

Then, arguably adding the final nail in the HCQ COVID-19 coffin, the NIH also decided that its Orchid study of HCQ would no longer continue after a fourth interim analysis by an independent data monitoring panel found the drug provided no additional benefit over placebo control. More than 470 patients were already enrolled at that point.

By: Angus Liu

Source: Fierce Pharma

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