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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infection; Covid19
• Intervention / Treatment: Drug: Ivermectin Tablets; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gabriela Avila, MD, MSc, PhD; Phone Number: 324 +59521683930; Email: mavila@med.una.py

Study Locations

• Paraguay
  • Asunción, Paraguay, 111421
    • Recruiting
    • Facultad de Ciencias Médicas - Universidad Nacional de Asunción
    • Contact: Gabriela Avila, MD, MSc, PhD; Phone Number: +59521683930; Email: mavila@med.una.py

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivermectin; Ivermectin 200mcg/kg single dose, maximum dose 18mg	Drug: Ivermectin Tablets; Oral ivermectin at a one time dose
Placebo Comparator: Placebo; Inactive medication tablets indistinguishable from ivermectin tablets	Other: Placebo; Oral placebo at a one time dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with hospitalization criteria	Proportion of patients with hospitalization criteria at day 30	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with COVID-19 signs and symptoms	Proportion of patients with COVID-19 signs and symptoms up to day 14	14 days
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
Drug-related adverse events	Proportion of patients with ivermectin adverse events up to day 30	30 days
Levels of IgG for SARS-CoV-2	Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay	30-60 days

Collaborators and Investigators

• Sponsor: Universidad Nacional de Asunción
• Collaborators: Consejo Nacional de Ciencias y Tecnología, Paraguay; Ministerio de Salud Pública y Bienestar Social, Paraguay; Centro de información y recursos para el desarrollo, Paraguay; Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay; Instituto Desarrollo, Paraguay

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• National Council of Science and Technology, Paraguay

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 4, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Respiratory Tract Infections; Ivermectin; Communicable Diseases
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: PINV20-387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No