Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial

Anan Manomaipiboon, Kittisak Pholtawornkulchai, Sujaree Poopipatpab, Swangjit Suraamornkul, Jakravoot Maneerit, Wiroj Ruksakul, Uraporn Phumisantiphong, Thananda Trakarnvanich, Anan Manomaipiboon, Kittisak Pholtawornkulchai, Sujaree Poopipatpab, Swangjit Suraamornkul, Jakravoot Maneerit, Wiroj Ruksakul, Uraporn Phumisantiphong, Thananda Trakarnvanich

Abstract

Background: The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pandemic. Ivermectin is an antiparasitic drug that has shown effectiveness against various agents, including SARS-CoV-2. This study aimed to assess the efficacy of ivermectin treatment compared with the standard of care (SOC) among people with mild to moderate COVID-19 symptoms.

Methods: In this randomized, double-blind, placebo-controlled, single-center, parallel-arm, superiority trial among adult hospitalized patients with mild to moderate COVID-19, 72 patients (mean age 48.57 ± 14.80 years) were randomly assigned to either the ivermectin (n=36) or placebo (n=36) group, along with receiving standard care. We aimed to compare the negativity of reverse transcription polymerase chain reaction (RT-PCR) result at days 7 and 14 of enrolment as the primary outcome. The secondary outcomes were duration of hospitalization, frequency of clinical worsening, survival on day 28, and adverse events.

Results: At days 7 and 14, no differences were observed in the proportion of PCR-positive patients (RR 0.97 at day 7 (p=0.759) and 0.95 at day 14 (p=0.813). No significant differences were found between the groups for any of the secondary endpoints, and no adverse events were reported.

Conclusion: No difference was found in the proportion of PCR-positive cases after treatment with ivermectin compared with standard care among patients with mild to moderate COVID-19 symptoms. However, early symptomatic recovery was observed without side effects.

Trial registration: ClinicalTrials.gov NCT05076253. Registered on 8 October 2021, prospectively.

Keywords: COVID-19; Efficacy; Ivermectin; RT-PCR; Randomized controlled trial; SARS-CoV-2.

Conflict of interest statement

The authors declare they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study protocol and randomization
Fig. 2
Fig. 2
Kaplan–Meier survival analysis curve for time to resolution of symptoms in the ivermectin group (n=32) versus controls (n=32) (p=0.553)

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