Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial

BMC Infect Dis. 2021 Jul 2;21(1):635. doi: 10.1186/s12879-021-06348-5.

Abstract

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients.

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 .

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • COVID-19 / drug therapy*
  • COVID-19 / etiology
  • COVID-19 / virology
  • COVID-19 Nucleic Acid Testing
  • Double-Blind Method
  • Female
  • Hospitalization
  • Humans
  • Ivermectin / adverse effects
  • Ivermectin / therapeutic use*
  • Length of Stay
  • Male
  • Middle Aged
  • Nasopharynx / virology
  • Placebos
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Placebos
  • Ivermectin

Associated data

  • ClinicalTrials.gov/NCT04529525