Affiliations 

  • 1 Department of Medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia
  • 2 Department of Medicine, Kepala Batas Hospital, Penang, Malaysia
  • 3 Department of Medicine, Sungai Buloh Hospital, Selangor, Malaysia
  • 4 Department of Medicine, Tumpat Hospital, Kelantan, Malaysia
  • 5 Department of Medicine, Taiping Hospital, Perak, Malaysia
  • 6 Department of Medicine, Penang Hospital, Penang, Malaysia
  • 7 Department of Medicine, Sultanah Aminah Hospital, Johor, Malaysia
  • 8 Department of Medicine, Sarawak General Hospital, Sarawak, Malaysia
  • 9 Department of Medicine, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia
  • 10 Department of Medicine, Sultanah Nur Zahirah Hospital, Terengganu, Malaysia
  • 11 Department of Medicine, Sultan Abdul Halim Hospital, Kedah, Malaysia
  • 12 Department of Medicine, Putrajaya Hospital, Putrajaya, Malaysia
  • 13 Department of Medicine, Sultanah Bahiyah Hospital, Kedah, Malaysia
  • 14 Department of Medicine, Lahad Datu Hospital, Sabah, Malaysia
  • 15 Department of Medicine, Duchess of Kent Hospital, Sabah, Malaysia
  • 16 Department of Medicine, Melaka Hospital, Malacca, Malaysia
  • 17 Department of Medicine, Tuanku Fauziah Hospital, Perlis, Malaysia
  • 18 Clinical Research Centre, Raja Permaisuri Bainun Hospital, Perak, Malaysia
  • 19 Department of Pharmacy, Sungai Buloh Hospital, Selangor, Malaysia
  • 20 Clinical Research Centre, Sarawak General Hospital, Sarawak, Malaysia
  • 21 School of Medicine, Taylor's University, Selangor, Malaysia
  • 22 Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia
JAMA Intern Med, 2022 Apr 01;182(4):426-435.
PMID: 35179551 DOI: 10.1001/jamainternmed.2022.0189

Abstract

IMPORTANCE: Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed.

OBJECTIVE: To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19.

DESIGN, SETTING, AND PARTICIPANTS: The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.

INTERVENTIONS: Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.

MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.

RESULTS: Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04920942.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.