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Clinical efficacy and safety of ivermectin (400 μg/kg, single dose) in patients with severe COVID-19: a randomized clinical trial

Ochoa-Jaramillo et al., Revista Infectio, doi:10.22354/24223794.1105, NCT04602507
Oct 2022  
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Mortality 57% Improvement Relative Risk Ventilation -34% ICU admission -37% primary Ivermectin  Ochoa-Jaramillo et al.  LATE TREATMENT  DB RCT Is late treatment with ivermectin beneficial for COVID-19? Double-blind RCT 75 patients in Colombia (December 2020 - December 2021) Lower mortality (p=0.35) and higher ICU admission (p=0.52), not sig. c19ivm.org Ochoa-Jaramillo et al., Revista Infectio, Oct 2022 Favorsivermectin Favorscontrol 0 0.5 1 1.5 2+
Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020, now with p < 0.00000000001 from 105 studies, recognized in 23 countries.
No treatment is 100% effective. Protocols combine treatments.
5,000+ studies for 104 treatments. c19ivm.org
RCT 75 very late stage patients in Colombia, showing no significant difference in outcomes with a single dose of 400μg/kg ivermectin.
Although the 57% lower mortality is not statistically significant, it is consistent with the significant 47% lower mortality [34‑58%] from meta analysis of the 53 mortality results to date.
This is the 44th of 52 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000021.
This is the 94th of 105 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 774 quintillion).
risk of death, 57.0% lower, HR 0.43, p = 0.35, treatment 2 of 37 (5.4%), control 4 of 38 (10.5%), NNT 20, Cox proportional hazards.
risk of mechanical ventilation, 34.0% higher, HR 1.34, p = 0.62, treatment 7 of 37 (18.9%), control 5 of 38 (13.2%), Cox proportional hazards.
risk of ICU admission, 37.0% higher, HR 1.37, p = 0.52, treatment 8 of 37 (21.6%), control 6 of 38 (15.8%), Cox proportional hazards, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ochoa-Jaramillo et al., 21 Oct 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Colombia, peer-reviewed, 8 authors, study period 10 December, 2020 - 9 December, 2021, average treatment delay 8.8 days, dosage 400μg/kg single dose, trial NCT04602507 (history).
This PaperIvermectinAll
Clinical efficacy and safety of ivermectin (400 μg/kg, single dose) in patients with severe COVID-19: a randomized clinical trial
Francisco Ochoa-Jaramillo, Nora Cardona-Castro, Federico Rodriguez-Vega, Veronica Posada-Velez, Diego Rojas-Gual- Dron, Heidy Contreras-Martinez, Ana Romero-Millan, Jessica Porras-Mansilla
Purpose: To evaluate the clinical efficacy of including Ivermectin (single dose on day 1 of 400 μg/kg PO) in the standard of care in hospitalized adults with severe COVID-19. Methods: Double-blinded, parallel, placebo-controlled, single-center, randomized clinical trial. Seventy-five patients were randomly assigned (1:1) to receive standard of care plus ivermectin or placebo and were followed up for 21 days. Primary outcome measure was admission to ICU and secondary outcomes were the requirement of intensive mechanical ventilation (IMV) and in-hospital death. Intention-to-treat analyses, estimated risk differences (RD), and Hazard ratios (HR) with Cox regression were performed. Results: Enrollment stopped due to the lack of eligible patients. Thirty-seven patients were assigned to intervention and 38 to placebo. Patients in the ivermectin group were 54.5 years on average, 62.2% were male. Comorbidities were more prevalent in the control group (78.9% vs. 56.8%). There was no difference in the 21-day risk of admission to the ICU between ivermectin (21.6%) and placebo (15.8%) (RD= 5.8%; 95%CI: -11.8%-23.5%); neither in the risk of requirement of IMV (18.9% vs 13.2%), mortality (5.4% vs 10.5%) or in adverse events (32.4% vs. 28.9%). Discussion: Ivermectin showed no significant benefit in reducing the requirement of ICU, IMV, or mortality for severe COVID-19 patients.
Financial Support. The study was supported by Fundación Cerro Matoso, Mineros SA, Servicios Generales Suramericana S.A.S., and the Direction of Research CES University. None of the funding sources had any direct or indirect involvement in the study's design, conduct, and completion. Declarations of interest. None. Author statement.
References
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Late treatment
is less effective
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