Anti-malaria drug Hydroxychloroquine may not benefit hospitalized patients with coronavirus (COVID-19), according to clinical trial conducted by the National Institutes of Health (NIH).
The NIH stopped the clinical trial after its data and safety monitoring board (DSMB) determined that while there was no harm, Hydroxychloroquine provides no benefit.
The DSMB, which regularly monitors the trial, recommended to the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, after its fourth interim analysis, to stop the study. NHLBI halted the trial immediately.
The symptomatic Disease study, or ORCHID Study, was being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of NHLBI.
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.
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.
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. The first participants enrolled in the trial in April.
The move to stop the clinical trial comes close on the heels of the FDA revoking the EUA to hydroxychloroquine for the treatment of hospitalized COVID-19 patients early last week. The World Health Organization had dropped hydroxychloroquine from its global study last week.
The FDA too had warned health care providers about the co-administration of investigational antiviral drug remdesivir and hydroxychloroquine for the treatment of hospitalized COVID-19 patients with severe disease.
Hydroxychloroquine is already FDA-approved to treat or prevent malaria. It is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.
Drug companies around the world arevying with each other to develop an effective treatment and vaccines against the deadly COVID-19 pandemic.
Across the United States, confirmed coronavirus cases have exceeded 2.28 million and the death toll has risen to nearly 119,980, as of this writing. New York continues to be the worst-hit state in the U.S. Worldwide, just over 8.97 million people have been infected, and nearly 468,590 people have died of the novel coronavirus so far, according to Johns Hopkins University data.
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