drugset / Trial / NCT04834115
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19
Phase 3
Unknown
400 enrolled
Universidad Nacional de Asunción
Centro de información y recursos para el desarrollo, Paraguay · collabCentro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay · collabConsejo Nacional de Ciencias y Tecnología, Paraguay · collabInstituto Desarrollo, Paraguay · collabMinisterio de Salud Pública y Bienestar Social, Paraguay · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.
Timeline
- Start
- 2020-11-17
- Primary completion
- 2021-04-30
- Completion
- 2021-05-30
Publications
- Background Lopez-Medina E, Lopez P, Hurtado IC, Davalos DM, Ramirez O, Martinez E, Diazgranados JA, Onate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendano AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071.
- Background Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
- Background Chaccour C, Ruiz-Castillo P, Richardson MA, Moncunill G, Casellas A, Carmona-Torre F, Giraldez M, Mota JS, Yuste JR, Azanza JR, Fernandez M, Reina G, Dobano C, Brew J, Sadaba B, Hammann F, Rabinovich R. The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial. Trials. 2020 Jun 8;21(1):498. doi: 10.1186/s13063-020-04421-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivermectin | Small molecule | 200 ug/kg | Oral |