Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial.
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Vallejos Julio, Zoni Rodrigo, Bangher María, Villamandos Silvina, Bobadilla Angelina, Plano Fabian, Campias Claudia, Chaparro Campias Evangelina, Medina Maria Fernanda, Achinelli Fernando, Guglielmone Hector Andres, Ojeda Jorge, Farizano Salazar Diego, Andino Gerardo, Kawerin Pablo, Dellamea Silvana, Aquino Antonia Cristina, Flores Victor, Martemucci Carolina N, Martinez Silvina Maria, Segovia Juan Emanuel, Reynoso Paola Itati, Sosa Noelia Carolina, Robledo Mariana Elizabeth, Guarrochena Joaquina Maria, Vernengo Maria Mercedes, Ruiz Diaz Natalia, Meza Elba, Aguirre María Gabriela
Аннотация
OBJECTIVE: To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19.
DESIGN, SETTING AND PARTICIPANTS: A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021.
INTERVENTION: Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days.
MAIN OUTCOMES AND MEASURES: The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points.
RESULTS: The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes.
LIMITATIONS: Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
CONCLUSION: Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04529525 .