Cluster Randomised Trials - Ivermectin Repurposing for Covid-19 Treatment of Outpatients with Mild Disease in Primary Health Care Centers

Background: The emergence of COVID-19 requires alternative treatments. This study aims to evaluate the therapeutic intervention with ivermectin in outpatients with COVID-19 mild disease, to increase discharge and prevent the progression to moderate or severe disease . Methods: : Randomized Trial in an overall ratio 1:1, n = 254. The subjects were divided into experimental (EG: n = 110) and control groups placebo (CG: n = 144). The EG received ivermectin orally 0.6 mg/kg weight in two doses. All participants were by physical examination COVID-19 diagnosed with negative RT-PCR at the beginning and the end of protocol. Differences between the variables were determined using the Chi-square test (p<0.05). The contagion risk (Odds Ratio) was calculated using software STATA. Results: : Both groups were similar in age, sex, and comorbidities. A significant reduction in the percentage of participants with symptoms (PPS) was observed in the EG and CG when the clinical evaluation of symptoms was performed from 5 th to 9 th ( p = 0·0005). When the clinical evaluation was performed from 10 th to 14 th day there was no significant difference. A higher proportion of outpatient discharge was observed in EG (98·2%) vs. CG (86·1%) ( p- Value = 0·0007). EG showed 8 times more chance of receiving discharge than CG (OR 8·71, 95% CI: 1·99 -38·12, p = 0·004). The treatment effect with ivermectin to obtain discharge from outpatient care was analyzed by the logistic regression. Then, the chance to obtain outpatient discharge was independent of variables sex, age, and comorbidities. Conclusion: Treatment with ivermectin in outpatients care with mild disease of COVID-19 managed to slightly reduce PPS. The treatment with ivermectin could significantly prevent the evolution to serious stages since the EG did not present any patient with referral to critical hospitalization. Retrospective Clinical Registration: ClinicalTrial.gov Identifier NCT04784481; Trial registrationdate: 03-05-2021. Last updated: 04-26-2021.