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Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind,
Julio Vallejos1, Rodrigo Zoni2, María Bangher1
1Instituto de Cardiología de Corrientes, Bolivar 1334, Zip code, 3400, Corrientes, Argentina.
Background:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients.
Objective:
To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19.
Design, Setting And Participants:
A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021.
Intervention:
Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days.
Main Outcomes And Measures:
The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points.
Results:
The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes.
Limitations:
Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.
Conclusion:
Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes.
Trial Registration:
ClinicalTrials.gov NCT04529525 .
Insights
Ivermectin did not significantly prevent hospitalization in early COVID-19 patients. Those treated with ivermectin required invasive mechanical ventilatory support earlier than the placebo group.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Trials
Background:
- The COVID-19 pandemic, caused by SARS-CoV-2, prompted research into repurposed treatments.
- Investigating ivermectin as a potential intervention for early-stage COVID-19 is crucial.
Purpose of the Study:
- To evaluate the efficacy of ivermectin in preventing hospitalization among non-hospitalized COVID-19 patients.
- To assess the safety and other efficacy endpoints of ivermectin treatment.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 501 non-hospitalized COVID-19 patients.
- Patients received either ivermectin or a placebo for two days, with staggered dosing based on weight.
- Primary outcome was hospitalization; secondary outcomes included safety and viral clearance.
Main Results:
- No statistically significant difference in hospitalization rates between the ivermectin (5.6%) and placebo (8.4%) groups (p=0.227).
- Patients receiving ivermectin showed a trend towards earlier need for invasive mechanical ventilatory support (5.25 days vs. 10 days, p=0.019).
- No significant differences were observed in secondary outcomes like PCR negativity or safety.
Conclusions:
- Ivermectin demonstrated no significant benefit in preventing hospitalization for COVID-19.
- Early use of ivermectin may be associated with an earlier requirement for mechanical ventilation.
- Further research is needed, considering limitations such as hospitalization event rates and population risk profiles.
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