Hydroxychloroquine provides no benefit for hospitalized COVID-19 patients, a study from the National Institutes of Health (NIH) has officially concluded.
The report was published in the Journal of the American Medical Association on Monday, though the NIH stopped the study in June on the recommendation of an independent data monitoring board.
The study found that while hydroxychloroquine did not cause any additional harm, it didn't help patients either.
The NIH study of hydroxychloroquine in hospitalized patients, dubbed ORCHID, began in April at 34 hospitals across the country. It had enrolled 479 out of 510 patients before preliminary evidence led the monitoring board to recommend stopping the trial.
Most of the patients in both the hydroxychloroquine group and the placebo group were hospitalized and receiving oxygen or invasive mechanical ventilation to maintain their breathing, NIH said.
Researchers assessed each patient’s clinical status 14 days after being assigned to a treatment group. Researchers also measured 12 additional outcomes, including death, that occurred 28 days after the participants’ assignment to a treatment group.
On day 14, those who received hydroxychloroquine and those who received a placebo had a similar health status. The number of participants in both treatment groups who died on day 14 was also similar.
By day 28, 25 out of 241 patients in the hydroxychloroquine group died, and 25 of 236 patients in the placebo group had died.
"While we hoped that hydroxychloroquine would help, even this is an important result as we work together to find effective treatments for COVID-19,” said Samuel Brown, a critical care physician at Intermountain Healthcare and an investigator who helped lead the trial.
The Food and Drug Administration (FDA) initially approved the emergency use of hydroxychloroquine as a potential COVID-19 treatment, before pulling it after studies showed it was ineffective and might cause harm in some patients.
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis and gained prominence early in the pandemic after it was touted as a treatment, prophylactic and miracle cure by President TrumpDonald TrumpTexas announces election audit in four counties after Trump demand Schumer sets Monday showdown on debt ceiling-government funding bill Pennsylvania AG sues to block GOP subpoenas in election probe MORE, his allies and members of his administration.
Many outside observers felt the FDA bowed to political pressure when it issued the authorization.
Rick Bright, an agency whistleblower who is now part of president-elect Joe BidenJoe BidenTexas announces election audit in four counties after Trump demand Pennsylvania AG sues to block GOP subpoenas in election probe House passes sweeping defense policy bill MORE's coronavirus advisory team, made similar accusations and said he lost his job for objecting to the drug's widespread promotion.