Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19.
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Bramante Carolyn T, Huling Jared D, Tignanelli Christopher J, Buse John B, Liebovitz David M, Nicklas Jacinda M, Cohen Kenneth, Puskarich Michael A, Belani Hrishikesh K, Proper Jennifer L, Siegel Lianne K, Klatt Nichole R, Odde David J, Luke Darlette G, Anderson Blake, Karger Amy B, Ingraham Nicholas E, Hartman Katrina M, Rao Via, Hagen Aubrey A, Patel Barkha, Fenno Sarah L, Avula Nandini, Reddy Neha V, Erickson Spencer M, Lindberg Sarah, Fricton Regina, Lee Samuel, Zaman Adnin, Saveraid Hanna G, Tordsen Walker J, Pullen Matthew F, Biros Michelle, Sherwood Nancy E, Thompson Jennifer L, Boulware David R, Murray Thomas A, COVID-OUT Trial Team
Аннотация
METHODS: In this phase 3, double-blind, randomized, placebo-controlled trial, we used a 2-by-3 factorial design to test the effectiveness of three repurposed drugs - metformin, ivermectin, and fluvoxamine - in preventing serious SARS-CoV-2 infection in nonhospitalized adults who had been enrolled within 3 days after a confirmed diagnosis of infection and less than 7 days after the onset of symptoms. The patients were between the ages of 30 and 85 years, and all had either overweight or obesity. The primary composite end point was hypoxemia (≤93% oxygen saturation on home oximetry), emergency department visit, hospitalization, or death. All analyses used controls who had undergone concurrent randomization and were adjusted for SARS-CoV-2 vaccination and receipt of other trial medications.
RESULTS: A total of 1431 patients underwent randomization; of these patients, 1323 were included in the primary analysis. The median age of the patients was 46 years; 56% were female (6% of whom were pregnant), and 52% had been vaccinated. The adjusted odds ratio for a primary event was 0.84 (95% confidence interval [CI], 0.66 to 1.09; P = 0.19) with metformin, 1.05 (95% CI, 0.76 to 1.45; P = 0.78) with ivermectin, and 0.94 (95% CI, 0.66 to 1.36; P = 0.75) with fluvoxamine. In prespecified secondary analyses, the adjusted odds ratio for emergency department visit, hospitalization, or death was 0.58 (95% CI, 0.35 to 0.94) with metformin, 1.39 (95% CI, 0.72 to 2.69) with ivermectin, and 1.17 (95% CI, 0.57 to 2.40) with fluvoxamine. The adjusted odds ratio for hospitalization or death was 0.47 (95% CI, 0.20 to 1.11) with metformin, 0.73 (95% CI, 0.19 to 2.77) with ivermectin, and 1.11 (95% CI, 0.33 to 3.76) with fluvoxamine.
CONCLUSIONS: None of the three medications that were evaluated prevented the occurrence of hypoxemia, an emergency department visit, hospitalization, or death associated with Covid-19. (Funded by the Parsemus Foundation and others; COVID-OUT ClinicalTrials.gov number, NCT04510194.).