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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04834115
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
Consejo Nacional de Ciencias y Tecnologia, 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
Information provided by (Responsible Party):
Universidad Nacional de Asunción

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Coronavirus Infection Drug: Ivermectin Tablets Other: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with hospitalization criteria [ Time Frame: 30 days ]
    Proportion of patients with hospitalization criteria at day 30


Secondary Outcome Measures :
  1. Proportion of patients with COVID-19 signs and symptoms [ Time Frame: 14 days ]
    Proportion of patients with COVID-19 signs and symptoms up to day 14

  2. Proportion of cohabitants who had COVID-19 after the index case [ Time Frame: 30 days ]
    Proportion of cohabitants who had COVID-19 after the index case up to day 30

  3. Drug-related adverse events [ Time Frame: 30 days ]
    Proportion of patients with ivermectin adverse events up to day 30

  4. Levels of IgG for SARS-CoV-2 [ Time Frame: 30-60 days ]
    Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834115


Contacts
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Contact: Gabriela Avila, MD, MSc, PhD +59521683930 ext 324 mavila@med.una.py

Locations
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Paraguay
Facultad de Ciencias Médicas - Universidad Nacional de Asunción Recruiting
Asunción, Paraguay, 111421
Contact: Gabriela Avila, MD, MSc, PhD    +59521683930    mavila@med.una.py   
Sponsors and Collaborators
Universidad Nacional de Asunción
Consejo Nacional de Ciencias y Tecnologia, 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
More Information
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Additional Information:

Publications:

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Responsible Party: Universidad Nacional de Asunción
ClinicalTrials.gov Identifier: NCT04834115    
Other Study ID Numbers: PINV20-387
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Nacional de Asunción:
Ivermectin
Communicable Diseases
Respiratory Tract Infections
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents