Results of two studies published in the BMJ showed that hydroxychloroquine did not significantly help people with COVID-19, dealing a blow to hopes that the antimalarial drug would be effective against the virus. There has been optimism that hydroxychloroquine could aid in the treatment of people infected with SARS-CoV-2, with US President Donald Trump recently touting use of the drug, taken together with the antibiotic azithromycin, as potentially "one of the biggest game-changers in the history of medicine."
However, there has been limited evidence supporting the use of hydroxychloroquine and azithromycin, with Anthony Fauci, director of the US National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases, earlier this week calling for "solid data from a large randomised, controlled clinical trial." Fauci's comments came as the NIH launched a Phase IIb study evaluating the combination of hydroxychloroquine plus azithromycin to treat patients with mild-to-moderate COVID-19 in the US.
In the first of the two studies published in the BMJ, researchers in China randomised 150 patients admitted to hospital with laboratory confirmed COVID-19 to receive hydroxychloroquine plus standard of care, or standard of care alone. Data showed that hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard of care alone, with the probability of negative conversion by day 28 in the two groups being 85.4% and 81.3%, respectively.
Meanwhile, adverse events were seen in 30% of patients who received hydroxychloroquine, versus 9% of those given standard of care alone. The researchers noted that the most common side effect in the hydroxychloroquine group was diarrhoea, reported in 10% of patients, while two subjects given the antimalarial experienced serious adverse events.
The second study, an observational one conducted in France, evaluated the effectiveness of hydroxychloroquine in patients admitted to hospital with COVID-19 pneumonia who require oxygen. In the trial, 181 patients with documented SARS-CoV-2 pneumonia who required oxygen but not intensive care received standard care plus hydroxychloroquine within 48 hours of hospital admission, or standard care without hydroxychloroquine.
For the main outcome, results showed that the survival rate without transfer to the intensive care unit at day 21 was 76% in the group that received hydroxychloroquine, compared to 75% in the standard care group. The researchers noted that overall survival at day 21 was 89% in the hydroxychloroquine arm, versus 91% in the control group, while survival without acute respiratory distress syndrome over the same timeframe was 69% and 74%, respectively.
The scientists added that 10% of patients who received hydroxychloroquine experienced electrocardiographic modifications that required discontinuation of treatment.
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