Effects of Ivermectin in Patients With COVID-19: A Multicenter, Double-blind, Randomized, Controlled Clinical Trial

Abstract

Purpose: Given the coronavirus disease 2019 (COVID-19) pandemic, there is a global urgency to discover an effective treatment for patients withthis disease. This study aimed to evaluate the effects of the widely used antiparasitic drug ivermectin on outcomes in patients with COVID-19.Methods: In this randomized, double-blind clinical trial, patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran, were randomly divided into 2 groups: 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; the control group received the standard of care. Demographic, clinical, laboratory, and imaging data from participants were recorded at baseline. Patients were assessed daily for symptoms and disease progression. The primary clinical outcome measures were the durations of hospital stay, fever, dyspnea, and cough; and overall clinical improvement.Findings: Sixty-nine patients were enrolled (mean [SD] ages: ivermectin, 47. 63 [22.20] years; control, 45.18 [23.11] years; P = 0.65). Eighteen patients (51.4%) in the ivermectin group and 18 (52.9%) in control group were male ( P = 0.90). The mean durations of dyspnea were 2.6 (0.4) days in the ivermectin group and 3.8 (0.4) days in the control group ( P = 0.048). Also, persistent cough lasted for 3.1 (0.4) days in the ivermectin group compared to 4.8 (0.4) days in control group (P P = 0.019). The mean durations of hospital stay were 7.1 (0.5) days versus 8.4 (0.6) days in the ivermectin and control groups, respectively ( P = 0.016). Also, the frequency of lymphopenia decreased to 14.3% in the ivermectin group and did not change in the control group ( P = 0.007).Implications: A single dose of ivermectin was well-tolerated in symptomatic patients with COVID-19, and important clinical features of COVID-19 were improved with ivermectin use, 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 be useful in understanding the potential clinical benefits ivermectin. Iranian Registry of Clinical Trials identifier: IRCT20111224008507N3.

Evaluation of Ivermectin as a Potential Treatment for Mild to Moderate COVID-19: A Double-Blind Randomized Placebo Controlled Trial in Eastern India

“…AIIMS-Patna is the highest referral institute in the state of Bihar for not only COVID-19 but for any medical or surgical condition owing to its state-ofthe-art facilities and trained healthcare staff. An Iranian RCT by Shahbaznejad et al (27) reported significantly lower duration of hospital stay [median ± standard error (SE): 6.0 ± 0.5 days)] in patients treated with single enteral dose of ivermectin compared to the placebo group [Median ± SE: 7.0 ± 0.4 days)] which was discordant to our observations. ICU support requirement were found to be similar in both the groups (9.1% in ivermectin group vs. 10.5% in placebo group) in the present study.…”

Effectiveness of Ivermectin-Based Multidrug Therapy in Severe Hypoxic Ambulatory COVID-19 Patients

“…IVM has been tested in more than 20 randomized controlled trials (RCTs) for COVID-19 treatment, with statistically highly significant clinical benefits in almost all of these and a pooled mortality reduction of 78% for the treatment vs. control groups [5]. Five such studies for IVM treatment of COVID-19 recently published in top-tier medical journals have all shown multiple clinical benefits for IVM vs. controls, most of these with high statistical significance on the order of p < 0.002 [6][7][8][9][10]. IVM is well tolerated at much greater than the standard single dose of 200 μg/kg [11,12] and has been used in RCTs for COVID-19 treatment at cumulative doses of 1,500 μg/kg [13], 1,600 μg/kg [14], and 3,000 μg/kg [15] over 4 or 5 days either without or with mild and transient adverse effects.…”

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

“…There was, however, some variation in the regimes used by these studies. Although the effect on viral clearance is not con rmed, there were many studies that reported a signi cant reduction in the time to recovery in the ivermectin group as compared to the control group [19][20][21]. Even when used to treat severe COVID-19 patients, ivermectin can provide an increase in clinical recovery, improvement in prognostic laboratory parameters, and a decrease in mortality rates [22].…”