Efficacy of Ivermectin in Outpatients With Non-severe COVID-19

Covid19 Clinical Trial

Official title:

Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834115
• Other study ID #: PINV20-387
• Status: Recruiting
• Phase: Phase 3
• Start date: November 17, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2021
• Source: Universidad Nacional de Asunción
• Contact: Gabriela Avila, MD, MSc, PhD
• Phone: +59521683930
• Email: mavila[@]med.una.py
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease. Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo. The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2
• Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2.
• Patients who agree to participate in the study by signing the informed consent.

Exclusion Criteria:

• Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)
• Pregnant or breastfeeding women
• Women of childbearing age and without commitment to use contraceptive methods during the study time.
• Inability to complete the study
• Current treatment with drugs known to interact with ivermectin
• Known intolerance to ivermectin, its derivate or any of its excipients.
• Patients with known Child-Pugh C liver disease
• Patients with prior ivermectin consumption in the 10 days prior to study entry.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Covid19
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Ivermectin Tablets
Oral ivermectin at a one time dose

Other:
• Placebo
Oral placebo at a one time dose

Locations

Country	Name	City	State
Paraguay	Facultad de Ciencias Médicas - Universidad Nacional de Asunción	Asunción

Sponsors (6)

Lead Sponsor	Collaborator
Universidad Nacional de Asunción	Centro de información y recursos para el desarrollo, Paraguay, Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay, Consejo Nacional de Ciencias y Tecnologia, Paraguay, Instituto Desarrollo, Paraguay, Ministerio de Salud Pública y Bienestar Social, Paraguay

Country where clinical trial is conducted

Paraguay, 

References & Publications (3)

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. — View Citation

Chaccour C, Ruiz-Castillo P, Richardson MA, Moncunill G, Casellas A, Carmona-Torre F, Giráldez M, Mota JS, Yuste JR, Azanza JR, Fernández M, Reina G, Dobaño 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. — View Citation

López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, Díazgranados JA, Oñate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendaño 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 Mar 4. doi: 10.1001/jama.2021.3071. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with hospitalization criteria	Proportion of patients with hospitalization criteria at day 30	30 days
Secondary	Proportion of patients with COVID-19 signs and symptoms	Proportion of patients with COVID-19 signs and symptoms up to day 14	14 days
Secondary	Proportion of cohabitants who had COVID-19 after the index case	Proportion of cohabitants who had COVID-19 after the index case up to day 30	30 days
Secondary	Drug-related adverse events	Proportion of patients with ivermectin adverse events up to day 30	30 days
Secondary	Levels of IgG for SARS-CoV-2	Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay	30-60 days

External Links

•   National Council of Science and Technology, Paraguay
•   Project Official Web Site