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Further evidence does not support hydroxychloroquine for patients with covid-19

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Further evidence does not support hydroxychloroquine for patients with covid-19

Adverse events were more common in those receiving the drug 

The anti-inflammatory drug hydroxychloroquine does not significantly reduce admission to intensive care or death in patients hospitalised with pneumonia due to covid-19, finds a study from France published by The BMJ today.

A randomised clinical trial from China also published today shows that hospitalised patients with mild to moderate persistent covid-19 who received hydroxychloroquine did not clear the virus more quickly than those receiving standard care. Adverse events were higher in those who received hydroxychloroquine.

Taken together, the results do not support routine use of hydroxychloroquine for patients with covid-19.

Hydroxychloroquine can reduce inflammation, pain, and swelling, and is widely used to treat rheumatic diseases. It is also used as an anti-malarial drug. Lab tests showed promising results, but accumulating trial and observational evidence has called into question whether there are any meaningful clinical benefits for patients with covid-19.

Despite this, hydroxychloroquine has already been included in Chinese guidelines on how best to manage the disease, and the US Food and Drug Administration (FDA) issued an emergency use authorization to allow the drug to be provided to certain hospitalized patients. The FDA has since warned against use outside clinical trials or hospital settings due to the risk of heart rhythm problems.

In the first study, researchers in France assessed the effectiveness and safety of hydroxychloroquine compared with standard care in adults admitted to hospital with pneumonia due to covid-19 who needed oxygen. 

Of 181 patients, 84 received hydroxychloroquine within 48 hours of admission and 97 did not (control group). 

They found no meaningful differences between the groups for transfer to intensive care, death within 7 days, or developing acute respiratory distress syndrome within 10 days.

The researchers say that caution is needed in the interpretation of their results, but that their findings do not support the use of hydroxychloroquine in patients hospitalised with covid-19 pneumonia.

In the second study, researchers in China assessed the effectiveness and safety of hydroxychloroquine compared with standard care in 150 adults hospitalised with mainly mild or moderate covid-19.

Patients were randomly split into two groups. Half received hydroxychloroquine in addition to standard care and the others received standard care only (control group).

By day 28, tests revealed similar rates of covid-19 in the two groups but adverse events were more common in those who received hydroxychloroquine. Symptom alleviation and time to relief of symptoms also did not differ meaningfully between the two groups.

While further work is needed to confirm these results, the authors say that their findings do not support the use of hydroxychloroquine to treat patients with persistent mild to moderate covid-19.

[Ends]

14/05/2020

Notes for editors
Research: Clinical efficacy of hydroxychloroquine in patients with covid-19 pneumonia who require oxygen: observational comparative study using routine care data
Research: Hydroxychloroquine in patients mainly with mild to moderate coronavirus disease 2019: open label, randomised, controlled trial
Journal: The BMJ

Non-peer reviewed, unedited preprint versions of these studies are available on medRxiv.

Funding
France study: none
China study: Emergent Projects of National Science and Technology, National Natural Science Foundation of China, National Key Research and Development Program of China, Shanghai Municipal Key Clinical Specialty, National Innovative Research Team of High-level Local Universities in Shanghai, Shanghai Key Discipline for Respiratory Diseases, National Major Scientific and Technological Special Project for Significant New Drugs Development, Key Projects in the National Science and Technology Pillar Program during the Thirteenth Five-year Plan Period.

Link to Academy of Medical Sciences press release labelling system: https://press.psprings.co.uk/AMSlabels.pdf

Peer reviewed? Yes
Evidence type: Observational comparative study; Randomised controlled trial
Subjects: Patients with covid-19

Link to France research: https://www.bmj.com/content/369/bmj.m1844

Link to China research: https://www.bmj.com/content/369/bmj.m1849

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