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

NCT04834115 | Unknown Phase 3 DMC

• 1 other identifier: PINV20-387
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Coronavirus Infection

Keywords

Ivermectin; Communicable Diseases; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with hospitalization criteria

  Proportion of patients with hospitalization criteria at day 30

  30 days

Secondary Outcomes (4)

• Proportion of patients with COVID-19 signs and symptoms

  14 days

• Proportion of cohabitants who had COVID-19 after the index case

  30 days

• Drug-related adverse events

  30 days

• Levels of IgG for SARS-CoV-2

  30-60 days

Study Arms (2)

Ivermectin

EXPERIMENTAL

Ivermectin 200mcg/kg single dose, maximum dose 18mg

Drug: Ivermectin Tablets

Placebo

PLACEBO COMPARATOR

Inactive medication tablets indistinguishable from ivermectin tablets

Other: Placebo

Interventions

Ivermectin Tablets DRUG

Oral ivermectin at a one time dose

Ivermectin

Placebo OTHER

Oral placebo at a one time dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Asunción, 111421, Paraguay

RECRUITING

Related Publications (3)

• 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.

  PMID: 33662102 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.

  PMID: 32251768 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.

  PMID: 32513289 BACKGROUND

Related Links

• National Council of Science and Technology, Paraguay

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Communicable Diseases; Respiratory Tract Infections

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Central Study Contacts

Gabriela Avila, MD, MSc, PhD

CONTACT

+59521683930; mavila@med.una.py

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing hospitalization in outpatients with COVID-19.

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 6, 2021
• Study Start: November 17, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)