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
Trials, doi:10.1186/s13063-022-06649-3
Background: The emergent outbreak of coronavirus disease , 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.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s13063-022-06649-3.
Additional file 1. Authors' contributions AM: supervised the project, had full access to the data in the study, and contributed to the study design. KP: contributed to data collection and conceived and designed the study. SS: collected and interpreted the data. JM: contributed in reviewing the design of the study and acquiring the data. WR: coordinated sample collection and oversaw data collection. UP: conducted and analyzed the laboratory results. TT: designed the study, analyzed, and interpreted the data and contributed towards the writing of the manuscript. All authors approve the final version of the manuscript for submission.
Declarations Ethics approval and consent to participate The study was conducted according to the guidelines of the Declaration of Helsinki and Good Clinical Practice Guidelines. The trial was approved by the Vajira Ethics Committee, approval no 171/64. Written informed consent was obtained from all subjects involved in the study.
Consent for publication Consent for publication is not applicable.
Competing interests The authors declare they have no competing interests.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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