Citing “main outcome” of death, researchers end chloroquine study due to safety concerns

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Citing “main outcome” of death, researchers cut short study of antimalarial drug chloroquine as a potential treatment for Covid-19 after some patients developed irregular heartbeats and nearly two dozen died after taking daily doses.

Scientists say results, published in the Journal of the American Medical Association on Friday, should arouse public skepticism about the enthusiastic claims and perhaps “serve to curb the exuberant use” of the drug, which has been touted by President Donald Trump as a potential “game changer” in the fight against coronavirus.

Chloroquine has attracted international attention following two small studies, one of which with 36 Covid-19 patients released March 17 in France, found that most patients taking the drug cleared the coronavirus from their systems much faster than the control group. The JAMA report said the tests did not meet the standards of the publishing company.

“These weak results, supported by anecdotal reports and media attention, have fueled a widespread belief in the effectiveness of these agents,” according to a separate drug prescription warning released Friday alongside the JAMA study.

The New York Times previously reported that the trial was halted for security reasons, but full details of the study were not released until their publication on Friday.

Research is fraught with political implications. A federal vaccine scientist who has been ousted from running an agency dealing with Covid-19 plans to file a whistleblower complaint alleging retaliation for his resistance to promoting Trump’s touted drugs, his lawyers said on Thursday.

Dr. Rick Bright said he believed he had been removed from office as head of the US Biomedical Advanced Research and Development Authority because he insisted that “the billions of dollars allocated by Congress to combat the Covid-19 pandemic “be invested” in reliable and scientifically verified sources. solutions, not drugs, vaccines and other technologies that lack scientific value. “

The JAMA study, sponsored by the Brazilian state of Amazonas, followed 81 adult patients hospitalized with Covid-19 and was conducted between March 23 and April 5 in a medical facility in Brazil. The researchers said 40 patients received 450 milligrams of the drug twice on the first day and once a day for the next four days. The other 41 received 600 milligrams twice a day for 10 days, they said. Patients also received the antibiotic azithromycin, commonly known as Z-Pak.

By day 13, six of 40 patients in the low-dose group had died, compared to 16 of 41 patients in the high-dose group. Cardiac abnormalities were observed in 11 of 81 patients. In addition, two patients in the high-dose group experienced ventricular tachycardia, a heart rhythm disorder.

“We can only conclude from this trial that high dose chloroquine (and by close association, hydroxychloroquine) in combination and azithromycin and perhaps oseltamivir, are potentially associated with increased mortality in patients with of COVID-19 severe and suspected, “Dr. Stephan Fihn of the Harborview Medical Center in Seattle, said in an editorial published concurrent with the study. He was not involved in the study.

There are no proven therapies to treat Covid-19, which infected more than 2.7 million people worldwide and killed at least 191,231 on Friday morning, according to data provided by Johns Hopkins University. The results of the study may reduce the hope that the antimalarial drug can be used to fight the virus.

The Food and Drug Administration warned consumers on Friday against taking chloroquine and hydroxychloroquine to treat Covid-19 outside of a hospital or formal clinical trial setting after “severe” poisoning and deaths have been reported. The warning was issued after JAMA shared the results of the study with the scientific community, but before they were released to the public on Friday.

The agency said it was aware of reports of “serious heart rhythm problems” in Covid-19 patients treated with antimalarial drugs, often in combination with the antibiotic azithromycin. He also warned doctors against prescribing drugs to treat coronavirus outside a hospital.

Chloroquine was approved by the FDA in 1949 to treat malaria. Its derivative, hydroxychloroquine, is often used by doctors to treat rheumatoid arthritis and lupus.

Some doctors are using these drugs in the hope that they will be able to reduce the duration of the virus in patients.

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