medwireNews: The addition of hydroxychloroquine to standard care does not result in better clinical outcomes among hospitalized patients with mild-to-moderate COVID-19, say the Coalition Covid-19 Brazil I investigators.
As reported in The New England Journal of Medicine, the phase 3 trial included 665 patients with confirmed or suspected COVID-19 who were receiving either no supplemental oxygen or a maximum of 4 L/min. Participants were randomly assigned to receive 7 days of treatment with hydroxychloroquine 400 mg twice daily plus local standard care, hydroxychloroquine 400 mg twice daily and azithromycin 500 mg/day plus standard care, or standard care only.
Among the 504 patients with confirmed COVID-19 and available follow-up data, there were no significant between-group differences in clinical status at the 15-day follow-up as measured by an ordinal scale ranging from 1 point (not hospitalized with no limitations on activities) to 7 points (death). The median score at week 15 was 1 point in all three groups, and hydroxychloroquine with or without azithromycin did not significantly affect the proportional odds of having a worse score.
Alexandre Cavalcanti (HCor Research Institute, São Paulo, Brazil) and colleagues say that patients treated with hydroxychloroquine, either alone or with azithromycin, had higher rates of adverse events (33.7 and 39.3 vs 22.6%), including QTc interval prolongation (14.6 and 14.7 vs 1.7%) and elevations in alanine aminotransferase or aspartate aminotransferase (8.5 and 10.9 vs 3.4%), compared with those in the standard care group.
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