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COVID-19 Chloroquine Study Stops Because of Abnormal Heart Rhythms, Deaths
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Mark Mascolini
Brazilian researchers halted one arm of a double-blind trial of chloroquine for COVID-19 because people taking the higher dose, 600 mg twice daily for 10 days, had more frequent heart rhythm disorders and deaths than people taking a lower dose [1].
Sponsored by the Brazilian state of Amazonas, the study involved 81 people recruited so far after hospital admission for COVID-19. The double-blind phase 2b trial (NCT04323527) randomized participants to receive oral or nasogastric chloroquine at a high dose (600 mg twice daily for 10 days, total dose 12 g) or a low dose (450 mg for 5 days, twice daily on the first day, total dose 2.7 g). Participants also received ceftriaxone and azithromycin.
One quarter of participants in the high-dose arm had QTc prolongation. There was a trend toward a higher death rate with high-dose arm chloroquine by study day 6 (17%). Overall mortality (13.5%, 95% CI 6.9% to 23.0%) overlapped with historical data from similar patients not taking chloroquine (95% CI 14.5% to 19.2%).
Only 1 person receiving the higher dose cleared virus from respiratory secretions during the study.
Researchers stopped recruitment to the high-dose arm because of the higher rates of heart rhythm disturbances and mortality. They concluded that “the higher chloroquine dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards.” And the study had too few participants in the low-dose arm “to estimate a clear benefit of chloroquine in patients with severe acute respiratory distress syndrome.”
Reference
1. Mayla Borba, Fernando de Almeida Val, Vanderson Sousa Sampaio, et al. Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study). medRxix doi: https://doi.org/10.1101/2020.04.07.20056424
https://www.medrxiv.org/content/10.1101/2020.04.07.20056424v1
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