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Status unknownNCT04834115Updated Apr 6, 2021

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

A Phase 3 interventional study of Ivermectin Tablets and Placebo in Covid19 and Coronavirus Infection, sponsored by Universidad Nacional de Asunción. Status unknown at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by Universidad Nacional de Asunción · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2020, registered Mar 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19
  • Coronavirus Infection

Keywords

  • Ivermectin
  • Communicable Diseases
  • Respiratory Tract Infections
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universidad Nacional de Asunción is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Ivermectin

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

    Drug: Ivermectin Tablets

  • Placebo comparator
    Placebo

    Inactive medication tablets indistinguishable from ivermectin tablets

    Other: Placebo

Interventions

  • DrugIvermectin Tablets

    Oral ivermectin at a one time dose

  • OtherPlacebo

    Oral placebo at a one time dose

06

What researchers measure

Primary outcomes

  1. Proportion of patients with hospitalization criteria

    Proportion of patients with hospitalization criteria at day 30

    Time frame: 30 days

Secondary outcomes

  1. Proportion of patients with COVID-19 signs and symptoms

    Proportion of patients with COVID-19 signs and symptoms up to day 14

    Time frame: 14 days

  2. 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

    Time frame: 30 days

  3. Drug-related adverse events

    Proportion of patients with ivermectin adverse events up to day 30

    Time frame: 30 days

  4. Levels of IgG for SARS-CoV-2

    Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay

    Time frame: 30-60 days

07

Study locations

1 of 1 sites recruiting
  • Facultad de Ciencias Médicas - Universidad Nacional de Asunción
    Asunción, 111421, Paraguay
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33662102 ↗
  • 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. PubMed 32251768 ↗
  • 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. PubMed 32513289 ↗

Individual participant data

Plan to share: No — The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04834115
Lead 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
Responsible party
Sponsor
First posted
Apr 6, 2021
Start date
Nov 17, 2020
Primary completion
Apr 30, 2021 (estimated)
Completion
May 30, 2021 (estimated)
Last update
Apr 6, 2021

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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