WASHINGTON: The US National Institutes of Health (NIH) announced that it has halted a clinical trial to evaluate the safety and effectiveness of the anti-malaria drug, hydroxychloroquine (HCQ) for the treatment of adults hospitalized with COVID-19.
According to the announcement on Saturday, a data and safety monitoring board met late Friday and determined that while there was no harm, the drug was very unlikely to be beneficial to hospitalized patients with COVID-19, reports Xinhua news agency.
The data from the Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, indicate that this drug provided no additional benefit compared to placebo control for the treatment of COVID-19 in hospitalized patients.
The first participants enrolled in the trial in April at the Vanderbilt University Medical Center, Nashville, Tennessee. The blinded, placebo-controlled randomized clinical trial aimed to enroll more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization.
More than 470 were enrolled at the time of study’s closure, according to the NIH. ORCHID participants had been randomly assigned to receive HCQ 400 mg twice daily for two doses on day one, then 200 mg twice daily for the subsequent eight doses on days two to five, or a placebo twice daily for five days.
The US Food and Drug Administration also revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and HCQ used to treat certain hospitalized patients with COVID-19 earlier this week. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and HCQ no longer outweigh the known and potential risks for the authorized use, said the FDA. Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis.
The NIH’s announcement comes after a World Health Organization (WHO) expert said last week that HCQ will be stopped from the Solidarity Trial, as it did not reduce the mortality rate of COVID-19 patients.
Earlier, Michael Ryan, executive director of WHO Health Emergencies Program, said that HCQ and chloroquine were included in the ongoing “Solidarity trials” that took place across multiple countries. WHO had advised that these drugs be reserved for the treatment of COVID-19 patients within such trials.
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