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.
【저자키워드】 COVID-19, Randomized controlled trial, Ivermectin, Efficacy, RT-PCR, SARS-CoV-2., 【초록키워드】 Treatment, coronavirus disease, SARS-CoV-2, coronavirus, pandemic, Trial, Symptoms, Moderate COVID-19, adverse events, Randomized, survival, outbreak, symptomatic, therapeutic, adverse event, Patient, Effectiveness, Mild, age, Placebo, reverse transcription, Side effects, group, placebo-controlled, Frequency, double-blind, Standard of care, acute respiratory syndrome, Primary outcome, significant difference, ivermectin treatment, standard care, Secondary endpoints, no difference, PCR-positive, worsening, single-center, secondary outcome, enrolment, n=36, negativity, antiparasitic drug, duration of hospitalization, Randomly, polymerase chain, shown, caused, proportion, reported, receiving, hospitalized patient, overcome, assigned, PCR-positive patient, 【제목키워드】 Treatment, Moderate COVID-19, Randomized, placebo-controlled trial, Mild, double-blind,