WHO Halts Hydroxychloroquine Study After Seeing No COVID-19 Benefit
WHO based its decision on an analysis showing that hydroxychloroquine showed no substantial benefit as treatment for patients hospitalized with COVID-19.
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By - The World Health Organization (WHO) temporarily paused the use of hydroxychloroquine (HCQ) in its Solidarity trial based on study results which showed the drug was not effective in treating hospitalized COVID-19 patients, according to a recent press release.
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WHO based its decision on results found in a publication in The Lancet, but noted that any medical evidence on hydroxychloroquine is preliminary at this point.
Currently, retrospective observational studies cannot show causality, but only association. Hydroxychloroquine is currently under investigation in multiple large and small scale clinical trials.
"The steering committee met over the weekend, in the light of this uncertainty," Soumya Swaminathan, WHO’s chief scientist, said in the release. "We decided we should be proactive, err on the side of caution and suspend enrollment temporarily into the hydroxychloroquine arm [of the Solidarity trial]."
After WHO’s announcement, Novartis stated that it would take note of this retrospective, observational study of existing multinational hospital registry data and evaluate the findings reported in the publication.
Novartis noted that a full assessment of the benefits and risks of HCQ must single out the effects of the study medication versus other medications given simultaneously, including placebo effects.
Patients’ pre-existing medical conditions must be considered as well, the company stated.
There may be no one size fits all treatment for COVID-19 patients, and treatments will look different depending on the severity and stage of disease, co-morbid conditions, medicine availability, and other factors, Novartis said.
“We remain committed to proceeding with the Novartis HCQ clinical trial to obtain much needed scientific data. We will continue to monitor other trials and review the medical information on the use of HCQ with a view to helping to identify the best treatment options for COVID-19 patients,” the company concluded.
Although experts previously deemed hydroxychloroquine as one of the most promising COVID-19 treatments, multiple clinical trials and studies have showed that the drug may not be as effective as they once believed.
Just last week, NIH halted its clinical trial evaluating the safety and effectiveness of hydroxychloroquine due to the drug being very unlikely to be beneficial in hospitalized COVID-19 patients.
The “Outcomes related to COVID-19 treated with hydroxychloroquine,” or ORCHID Study, was conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of National Heart, Lung, and Blood Institute (NHLBI).
The monitoring board (DSMB), which regularly monitored the trial, determined that although there was no harm to patients, hydroxychloroquine provided no additional benefit compared to placebo control for the treatment of COVID-19.
After its fourth interim analysis, the DSMB recommended NHLBI to stop the study. NHLBI halted the trial immediately.
Back in April, the first participants enrolled in the blinded, placebo-controlled randomized clinical trial at Vanderbilt University Medical Center, one of dozens of centers in the PETAL Network.
Researchers intended to enroll more than 500 adults who are currently hospitalized with COVID-19 or an emergency room with anticipated hospitalization, NIH said. Over 470 were enrolled at the time of the study’s closure.
Additionally, FDA revoked the Emergency Use Authorization (EUA) for chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) in mid-June.
FDA stated that the decision to reverse the EUA was based on newly gathered information including clinical trial data results that led the agency to conclude that the drug may not be an effective COVID-19 treatment.
The agency concluded that hydroxychloroquine no longer met criteria due to various different bases, such as that the dosing regimens did not produce an antiviral effect and there was no substantial difference between the drug and standard care.
“FDA has concluded that, based on new information and other information in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” the press release stated.
