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

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

A randomized clinical trial from China, published at the same time, shows hospitalized patients with mild to moderate persistent COVID-19 who received hydroxychloroquine did not clear the virus more quickly than those receiving standard care. In fact, adverse events were actually higher in those who received hydroxychloroquine.

Taken together, the results do not support routine use of hydroxychloroquine for patients afflicted with the coronavirus.

Hydroxychloroquine can reduce inflammation, pain and swelling, and is widely used to treat rheumatic diseases. It's 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 COVID patients.

Despite this, hydroxychloroquine has already been included in Chinese guidelines on how best to manage the disease, and the U.S. Food and Drug Administration 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.

WHAT'S THE IMPACT

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

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

There were no meaningful differences between the groups for transfer to intensive care, death within seven days, or developing acute respiratory distress syndrome within 10 days.

The researchers say 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.

By day 28, tests revealed similar rates of the coronavirus 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 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 coronavirus patients.

THE LARGER TREND

While the early promises of hydroxychloroquine aren't panning out, new potential drug treatments have emerged. Results of a randomized trial published last week show that a two-week course of antiviral therapy with interferon beta-1b, plus lopinavir-ritonavir and ribavirin, started within seven days of showing COVID-19 symptoms, is safe and more effective at reducing the duration of viral shedding than lopinavir-ritonavir alone in patients with mild to moderate illness.

Previous research found that a combination of oral lopinavir-ritonavir (normally used to treat HIV) and ribavirin (an oral hepatitis C virus drug) significantly reduced respiratory failure and death in patients hospitalized with SARS during the 2003 outbreak. Interferon beta-1b, which was developed to treat multiple sclerosis, has been shown to reduce viral load and improve lung problems in animal studies of the MERS coronavirus infection.

Twitter: @JELagasse

Email the writer: jeff.lagasse@himssmedia.com