US halts clinical trial of Trump-touted hydroxychloroquine after finding no benefit to coronavirus patients
The US has halted a clinical trial that was evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with Covid-19. A data and safety monitoring board (DSMB) determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with the new coronavirus, said the National Institutes of Health (NIH).
“After its fourth interim analysis, the DSMB, which regularly monitors the trial, recommended to the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, to stop the study. NHLBI halted the trial immediately. The Outcomes Related to Covid-19 treated with hydroxychloroquine among in-patients with symptomatic disease (ORCHID) study was being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of NHLBI. The data from this study indicate that this drug provided no additional benefit compared to placebo control for the treatment of Covid-19 in hospitalized patients,” said the NIH in a statement.
The latest announcement comes close on the heels of a decision by the US Food and Drug Administration (FDA) to withdraw its emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat hospitalized Covid-19 patients. The FDA said that the two drugs are unlikely to be effective and could carry potential risks. According to the agency, as of May 6, there were 347 adverse events in Covid-19 patients taking hydroxychloroquine and 38 in those taking chloroquine.
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. The drug has often been touted by US President Donald Trump as a potential therapy against coronavirus. The NIH said that in some studies, the drug had demonstrated antiviral activity, an ability to modify the activity of the immune system, and it has an established safety profile at appropriate doses, leading to the hypothesis that it may have also been useful in the treatment of Covid-19.
More than 470 were enrolled at the time of the study’s closure by NIH. The first participants enrolled in the trial in April at Vanderbilt University Medical Center, Nashville, Tennessee, one of the dozens of centers in the PETAL Network. ORCHID participants had been randomly assigned to receive hydroxychloroquine 400 mg twice daily for two doses (day one), then 200 mg twice daily for the subsequent eight doses (days two to five) or a placebo twice daily for five days. “All participants in the study received clinical care as indicated for their condition. Those randomized to the experimental intervention had also received hydroxychloroquine. Participants in the study will now continue to receive standard of care and follow up as indicated for their condition,” said NIH.
Recently, the World Health Organization (WHO) announced that the hydroxychloroquine arm of the Solidarity trial to find an effective Covid-19 treatment was being stopped. The trial's executive group and principal investigators made the decision based on evidence from the Solidarity trial, UK's Recovery trial, and a review of other evidence on hydroxychloroquine, said the agency on June 17. “Data from Solidarity (including the French Discovery trial data) and the recently announced results from the UK's Recovery trial both showed that hydroxychloroquine does not result in the reduction of mortality of hospitalized Covid-19 patients when compared with standard of care,” said a statement.
The Solidarity trial is an international clinical trial to help find an effective treatment for Covid-19, launched by WHO and partners. “Investigators will not randomize further patients to hydroxychloroquine in the Solidarity trial. Patients who have already started hydroxychloroquine but who have not yet finished their course in the trial may complete their course or stop at the discretion of the supervising physician,” said the WHO.