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Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a
Carmen de la Rocha1,2, Marco A Cid-López1, Blanca I Venegas-López1
1Investigación Biomédica Para El Desarrollo de Fármacos S.A. de C.V. Zapopan, Tonalá, Jalisco, México.
Background:
Despite the development and application of vaccines against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) around the world, the scientific community is still trying to find some therapies to avoid or ameliorate the fatal evolution of the Coronavirus disease 2019 (COVID-19). Since the publication of the potential use of ivermectin as a treatment against the disease, a pleiad of information about it has been published. However, the evidence is not strong or weak enough to conclude its usefulness in the clinical evolution of patients infected with SARS-CoV-2. We evaluate the efficacy and safety of ivermectin in the treatment of Mexican patients with asymptomatic and mild COVID-19 in a three-day administration in comparison to placebo.
Methods:
A randomized, double-blind, placebo-controlled trial was carried out in 66 adults with asymptomatic and mild COVID-19. Patients were randomly assigned 1:1 ratio to ivermectin plus acetaminophen or placebo plus acetaminophen. The primary endpoint was the proportion of subjects without a disease progression to severity according to COVID-19 guidelines by the National Institutes of Health (NIH) since randomization to 14 days.
Results:
None of the participants presented progression to a severe state in either group. Viral load was measured on Days 1, 5, and 14. No significant differences were observed in baseline or 14-day between groups (p = 0.720 and 0.362, respectively). However, on Day 5, a significant difference in viral load was observed between groups (p = 0.039). The frequency of symptoms was similar between groups, and no significant differences were observed. The most frequent symptom was cough. One severe adverse event associated with SARS-CoV-2 infection was observed in the ivermectin group.
Conclusions:
At standard doses, ivermectin is not effective to prevent progression to a severe state or reducing symptoms in adults with asymptomatic and mild COVID-19. Trial registration The study was registered with ClinicalTrial.gov (NCT04407507) on May 29, 2020.
Insights
Ivermectin did not prevent severe illness or reduce symptoms in mild COVID-19 patients. This study found no significant difference in disease progression or symptom frequency between ivermectin and placebo groups.
Area of Science:
- Infectious Diseases
- Pharmacology
Background:
- Ongoing search for effective COVID-19 therapies alongside vaccination efforts.
- Ivermectin has been proposed as a potential treatment for COVID-19, but evidence remains inconclusive.
- Need for robust clinical trials to assess ivermectin's efficacy and safety.
Purpose of the Study:
- To evaluate the efficacy and safety of ivermectin in Mexican patients with asymptomatic and mild COVID-19.
- To compare a three-day administration of ivermectin plus acetaminophen against placebo plus acetaminophen.
- To assess disease progression to severity and viral load changes.
Main Methods:
- Randomized, double-blind, placebo-controlled trial with 66 adult participants.
- Participants were assigned to either ivermectin or placebo plus acetaminophen (1:1 ratio).
- Primary endpoint: proportion of subjects without disease progression to severity within 14 days, per NIH guidelines.
Main Results:
- No participants in either group progressed to severe COVID-19.
- Viral load showed no significant difference at baseline or Day 14, but a significant difference was observed on Day 5 (p=0.039).
- Symptom frequency, including cough, was similar between groups; one severe adverse event occurred in the ivermectin group.
Conclusions:
- Standard doses of ivermectin are not effective in preventing progression to severe COVID-19 in mild cases.
- Ivermectin did not demonstrate efficacy in reducing symptoms in adults with asymptomatic and mild COVID-19.
- The study was registered with ClinicalTrials.gov (NCT04407507).
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