Hydroxychloroquine does not work, and should not be given to hospitalized coronavirus patients, National Institutes of Health scientists declared in a new study.
The controversial malaria drug was touted (despite a lack of clear evidence) as a possible ‘cure’ for COVID-19 by President Donald in the spring and given emergency approval by the Food and Drug Administration (FDA) in March.
Regulators revoked that approval in June, however, after reports emerged of heart problems in people who were given the drug, and as studies suggesting the drug was not helping coronavirus patients were published.
The NIH stopped its hydroxychloroquine trial on June 19, because of its ‘futility,’ and found hospitalized coronavirus patients given hydroxychloroquine fared no better than those who got a placebo, according to the study published Monday in JAMA.
An NIH study has finally formally declared that hydroxychloroquine does not help hospitalized coronavirus patients recover
As the U.S. reeled from the whiplash of research suggesting hydroxychloroquine did and didn’t work to treat coronavirus, the NIH was kicking of a large, gold-standard trial.
Their study randomly gave half of a group of 479 hospitalized COVID-19 patients hydroxychloroquine and the other half a placebo.
Neither the patients nor the health care workers looking after them knew who got the real drug and who got the placebo.
Two weeks after they were admitted and dosed with either the real or sham treatment, 32.3 percent of those who got hydroxychloroquine were discharged and ready to go back to their normal lives.
By comparison, 29.1 percent who got the placebo drug were released without restrictions on their activities.
Scientifically speaking, that is not a significant difference.
At 28 days after starting treatment, the rates of discharge were almost identical with 47.9 percent on hydroxychloroquine and 47.7 on the placebo released from hospitals.
Survival rates were actually higher among the coronavirus patients who got a placebo after 14 days (top, blue), but were almost exactly the same among them and the hydroxychloroquine group (orange) after 28 days
Discharge rates (white, lightest blue) were slightly higher among patients who got hydroxychloroquine at 14 days (left)(, but were identical by day 28 (right)
Fourteen days after admission and treatment, the death rate was actually higher in the hydroxychloroquine group, at 7.4 percent, compared to 5.9 percent of the placebo group.
These rates had evened out by day 28 as well. By that point, 25 people in each group had died, equating to 10.3 percent of the hydroxychloroquine group and 10.3 percent of the placebo group.
And symptoms while hospitalized were no milder among the people who got the malaria drug, compared to those who didn’t.
Ultimately, the trial met the same fate as several other tests of hydroxychloroquine: it was stopped early because the NIH investigators had more than enough evidence that the experimental drug was not helping their patients.
‘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 Dr Samuel Brown, a critical care specialist at Intermountain Healthcare who helped run the trial.
The drug got international attention after lab studies suggested it might combat the virus in petri dishes and French researchers claimed it drastically boosted survival rates.
Because hydroxychloroquine is already FDA approved to treat malaria, lupus and rheumatoid arthritis, there was hope the readily available drug could be a desperately needed treatment.
Doctors started prescribing it, driving shortages in some places. President Trump hailed it a ‘gift from God’ and even took it himself as a preventive (studies have now found hydroxychloroquine is ineffective for this purpose too).
But the new study is the NIH’s clearest ruling on the drug, despite FDA warnings against using it in coronavirus patients with heart problems.
‘Hydroxychloroquine was not efficacious for the treatment of COVID-19,’ the NIH authors concluded, perhaps finally putting to rest months of heated debate over the drug.
It comes as remdesivir falls out of favor as an antiviral as well and U.S. and World Health Organization (WHO) officials turn their attention to antibody treatments and vaccines, including Pfizer’s, which was found to prevent 90 percent of infections Monday.