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

Primary Purpose

Covid19, Coronavirus Infection

Status
Unknown status
Phase
Phase 3
Locations
Paraguay
Study Type
Interventional
Intervention
Ivermectin Tablets
Placebo
Sponsored by
Universidad Nacional de Asunción
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Ivermectin, Communicable Diseases, Respiratory Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Facultad de Ciencias Médicas - Universidad Nacional de AsunciónRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivermectin

Placebo

Arm Description

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

Inactive medication tablets indistinguishable from ivermectin tablets

Outcomes

Primary Outcome Measures

Proportion of patients with hospitalization criteria
Proportion of patients with hospitalization criteria at day 30

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2021
Last Updated
April 4, 2021
Sponsor
Universidad Nacional de Asunción
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
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1. Study Identification

Unique Protocol Identification Number
NCT04834115
Brief Title
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19
Official Title
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Nacional de Asunción
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Coronavirus Infection
Keywords
Ivermectin, Communicable Diseases, Respiratory Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin
Arm Type
Experimental
Arm Description
Ivermectin 200mcg/kg single dose, maximum dose 18mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive medication tablets indistinguishable from ivermectin tablets
Intervention Type
Drug
Intervention Name(s)
Ivermectin Tablets
Intervention Description
Oral ivermectin at a one time dose
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral placebo at a one time dose
Primary Outcome Measure Information:
Title
Proportion of patients with hospitalization criteria
Description
Proportion of patients with hospitalization criteria at day 30
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Proportion of patients with COVID-19 signs and symptoms
Description
Proportion of patients with COVID-19 signs and symptoms up to day 14
Time Frame
14 days
Title
Proportion of cohabitants who had COVID-19 after the index case
Description
Proportion of cohabitants who had COVID-19 after the index case up to day 30
Time Frame
30 days
Title
Drug-related adverse events
Description
Proportion of patients with ivermectin adverse events up to day 30
Time Frame
30 days
Title
Levels of IgG for SARS-CoV-2
Description
Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay
Time Frame
30-60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Avila, MD, MSc, PhD
Phone
+59521683930
Ext
324
Email
mavila@med.una.py
Facility Information:
Facility Name
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
City
Asunción
ZIP/Postal Code
111421
Country
Paraguay
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Avila, MD, MSc, PhD
Phone
+59521683930
Email
mavila@med.una.py

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.
Citations:
PubMed Identifier
33662102
Citation
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.
Results Reference
background
PubMed Identifier
32251768
Citation
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.
Results Reference
background
PubMed Identifier
32513289
Citation
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.
Results Reference
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Links:
URL
https://datos.conacyt.gov.py/proyectos/pdf/3449
Description
National Council of Science and Technology, Paraguay

Learn more about this trial

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

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