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Randomized Controlled Trial
. 2022 Aug 26;23(1):714.
doi: 10.1186/s13063-022-06649-3.

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

Anan Manomaipiboon  1 , Kittisak Pholtawornkulchai  1 , Sujaree Poopipatpab  1 , Swangjit Suraamornkul  1 , Jakravoot Maneerit  1 , Wiroj Ruksakul  1 , Uraporn Phumisantiphong  1 , Thananda Trakarnvanich  2
Affiliations
Randomized Controlled Trial

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

Anan Manomaipiboon et al. Trials. .

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.

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Conflict of interest statement

The authors declare they have no competing interests.

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)
See this image and copyright information in PMC

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