HydroxychloroquineNo Evidence of Benefit for Chloroquine and Hydroxychloroquine in COVID-19 Patients, Study Finds

Published 25 May 2020

A large observational study suggests that treatment with the antimalarial drug chloroquine or its analogue hydroxychloroquine (taken with or without the antibiotics azithromycin or clarithromycin) offers no benefit for patients with COVID-19. Prof. Dr. Mandeep R. Mehra, lead author of the study, which was published in The Lancet, said: “This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19. Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death.” Writing in a linked The Lancet “Comment” article, Professor Christian Funck-Brentano, of the Sorbonne University in Paris (who was not involved in the study), said: “This well-conducted observational study adds to preliminary reports suggesting that chloroquine, hydroxychloroquine, alone or with azithromycin is not useful and may be harmful in hospitalized COVID-19 patients.”

A large observational study, published in The Lancet, suggests that treatment with the antimalarial drug chloroquine or its analogue hydroxychloroquine (taken with or without the antibiotics azithromycin or clarithromycin) offers no benefit for patients with COVID-19. The study analyzed data from nearly 15,000 patients with COVID-19 receiving a combination of any of the four drug regimens and 81,000 controls.

Treatment with these medications among patients with COVID-19, either alone or in combination with macrolide antibiotics, was linked to an increased risk of serious heart rhythm complications in these patients.

Researchers suggest these treatment regimens should not be used to treat COVID-19 outside of clinical trials until results from randomized clinical trials are available to confirm the safety and efficacy of these medications for COVID-19 patients.

Chloroquine is an antimalarial drug and its analogue, hydroxychloroquine, is used to treat autoimmune diseases including lupus and arthritis. Both drugs have a good safety profile as treatments for those specific conditions, and the findings do not imply patients should stop taking these drugs if they are prescribed for approved conditions. They have also been shown to have antiviral effects in laboratory tests and are therefore of interest as potential treatments for COVID-19.

Prof. Dr. Mandeep R. Mehra, lead author of the study and Executive Director of the Brigham and Women’s Hospital Center for Advanced Heart Disease in Boston, said: “This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19. Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death. Randomized clinical trials are essential to confirm any harms or benefits associated with these agents. In the meantime, we suggest these drugs should not be used as treatments for COVID-19 outside of clinical trials.”

The Lancet reports that in the study, researchers analyzed data from 96,032 patients hospitalized between 20 December 2019 and 14 April 2020 with laboratory confirmed SARS-CoV-2 infection from 671 hospitals. All of the patients included in the study had either been discharged or had died by 21 April 2020.

The team compared outcomes from patients treated with chloroquine alone (1,868), hydroxychloroquine alone (3,016), chloroquine in combination with a macrolide (3,783) or hydroxychloroquine with a macrolide (6,221). Patients from these four groups were compared with the remaining control group of 81,144 patients.