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Hydroxychloroquine again fails to show benefit in COVID-19 patients — New York study

The malaria treatment repeatedly championed by US President Donald Trump as a “game changer” in the fight against the novel coronavirus has again failed to show a benefit in patients hospitalized with COVID-19. Reuters Health reports that this is according to a study that found, despite certain limitations, that the use of hydroxychloroquine neither lessened the need for patients requiring breathing assistance nor the risk of death.

“We didn’t see any association between getting this medicine and the chance of dying or being intubated,” lead researcher Dr Neil Schluger is quoted in the report as saying. “The patients who got the drug didn’t seem to do any better.”

Among patients given hydroxychloroquine, 32.3% ended up needing a ventilator or dying, compared with 14.9% of patients who were not given the drug. But doctors were more likely to give hydroxychloroquine to sicker patients, so researchers at New York-Presbyterian Hospital and Columbia University Irving Medical Centre adjusted the rates to account for that. They concluded that the drug may not have hurt patients, but it clearly did not help.

Decades old hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis, also showed no benefit when combined with the antibiotic azithromycin, Schluger’s team reported. Azithromycin alone also showed no benefit.

Last month, the report says, doctors at the US Department of Veterans Affairs reported that hydroxychloroquine did not help COVID-19 patients and might pose a higher risk of death. That analysis of medical records showed a death rate of 28% when the drug was given in addition to standard treatments, compared to 11% with standard care alone.

In the latest study, 811 patients got hydroxychloroquine and 565 did not. Because they were not randomly assigned to receive hydroxychloroquine or a placebo, “the study should not be taken to rule out either benefit or harm” for the drug, researchers said.

Randomised trials, the gold standard for tests of new therapies, should continue, they added. But for now, “the guidance in our hospital has changed so we don’t recommend giving hydroxychloroquine to hospitalised patients,” said Schluger, chief of the division of pulmonary, allergy and critical care medicine at Irving.

Smaller studies, including one done in China, had suggested hydroxychloroquine might be useful, “but these were tiny studies and not of good quality. People seized on them because patients were dying,” he is quoted in the report as saying.

Abstract
Background: Hydroxychloroquine has been widely administered to patients with Covid-19 without robust evidence supporting its use.
Methods: We examined the association between hydroxychloroquine use and intubation or death at a large medical center in New York City. Data were obtained regarding consecutive patients hospitalized with Covid-19, excluding those who were intubated, died, or discharged within 24 hours after presentation to the emergency department (study baseline). The primary end point was a composite of intubation or death in a time-to-event analysis. We compared outcomes in patients who received hydroxychloroquine with those in patients who did not, using a multivariable Cox model with inverse probability weighting according to the propensity score.

Results: Of 1446 consecutive patients, 70 patients were intubated, died, or discharged within 24 hours after presentation and were excluded from the analysis. Of the remaining 1376 patients, during a median follow-up of 22.5 days, 811 (58.9%) received hydroxychloroquine (600 mg twice on day 1, then 400 mg daily for a median of 5 days); 45.8% of the patients were treated within 24 hours after presentation to the emergency department, and 85.9% within 48 hours. Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive hydroxychloroquine (median ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen, 223 vs. 360). Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association between hydroxychloroquine use and intubation or death (hazard ratio, 1.04, 95% confidence interval, 0.82 to 1.32). Results were similar in multiple sensitivity analyses.
Conclusions: In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed.

Authors
Joshua Geleris, Yifei Sun, Jonathan Platt, Jason Zucker, Matthew Baldwin, George Hripcsak, Angelena Labella, Daniel Manson, Christine Kubin, R Graham Barr, Magdalena E Sobieszczyk, Neil W Schluger

[link url="https://uk.reuters.com/article/us-health-coronavirus-hydroxychloroquine/malaria-drug-touted-by-trump-for-coronavirus-fails-another-test-idUKKBN22J3FP"]Full Reuters Health report[/link]

[link url="https://www.nejm.org/doi/full/10.1056/NEJMoa2012410"]NEMJ abstract[/link]

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