Effects of Ivermectin in Patients With COVID-19: A Multicenter, Double-blind, Randomized, Controlled Clinical Trial
Leila Shahbaznejad, MD Alireza Davoudi, MD; Gohar Gohar Eslami, PharmD; John S Markowitz, Mohammad Reza Navaeifar, MD Fatemeh Hosseinzadeh, Faeze Sadat Movahedi, MSc Mohammad Sadegh Rezai
Clinical Therapeutics, doi:10.1016/j.clinthera.2021.04.007
Purpose. Given the coronavirus disease-2019 (COVID-19) pandemic, there is a global urgency to discover an effective treatment against this disease. This study aimed to evaluate the effect of the widely used antiparasitic drug ivermectin on COVID-19 patient outcomes. Methods. In this randomized double-blind clinical trial, COVID-19 patients admitted to two referral tertiary hospitals of Mazandaran, north of Iran, were randomly divided into two groups of intervention and control. In addition to standard treatment for COVID-19, the intervention group received a single weight-based dose (0.2 mg/kg) of ivermectin. Demographic, clinical, laboratory and imaging data of participants were recorded at baseline. Patients were daily assessed for clinical complaints and disease progression. The primary clinical outcome measures were duration of hospital stay, fever, dyspnea, cough, and overall clinical improvement. Findings. Sixty-nine patients with the mean age of 47.6±22.2 and 45.2±23.1 years participated in intervention and control groups, respectively (p=0.6). Nineteen patients (54%) in the ivermectin group and 18(53%) in control group were male (p=0.9). The mean duration of dyspnea was 2.4±1.7 days in the ivermectin and 3.7±2.1 days in the control group (p=0.02). Also, persistent cough lasted for 3.1±1.9 days in the ivermectin group compared to 4.8±2.0 days in control group (p=0.00). The mean duration of hospital stay was 6.9±3.1 vs 8.3±3.3 days for the ivermectin and control group, respectively (p=0.01). Also, the frequency of lymphopenia decreased to 14.3% in the ivermectin group and did not change in the control group (p=0.00). Implications. A single dose of ivermectin was well-tolerated in symptomatic COVID-19 patients and improved important clinical features of COVID-19 patients including dyspnea, cough, and lymphopenia. Further studies with larger sample sizes, different drug dosages, dosing intervals and durations, especially in different stages of the disease, may help understanding ivermectin's potential clinical benefits. Trial registration. The current controlled trial was registered in the Iranian Registry of Clinical Trials
Declaration of Competing Interest The authors have declared that no competing interests exist.
Authors' Contributions MSR and LSh contributed to study conception and design. ARD, MSR and LSh contributed to data collection and patient sampling. FH and MRN contributed to drafting and editing the manuscript. FSM performed the statistical analysis. MSR, LSh and FH revised the manuscript. MSR and GE provided study supervision. JSM assisted in the drafting and editing the manuscript All authors read and approved the submitted manuscript.
Consent for publication Written informed consent was obtained from the patients or their parents prior to manuscript submission for their personal or clinical details in addition to any identifying images to be published in this study.
Ethics approval and consent to participate The ethics committee of Mazandaran University of Medical Sciences approved the study protocol (Code: IR.MAZUMS.REC.1399.057) and it was registered in the Iranian Registry of Clinical Trials (code: IRCT20111224008507N3). The patients of this manuscript have not been reported in any other submission by us or anyone else.
Availability of data and material All data generated or analyzed during this study are included in this published article. For additional data, please contact the corresponding author (email@example.com).
Financial disclosure The authors received no specific funding for this work.
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