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

Overview

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.

Full Title of Study: “Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2021

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.

Interventions

  • Drug: Ivermectin Tablets
    • Oral ivermectin at a one time dose
  • Other: Placebo
    • Oral placebo at a one time dose

Arms, Groups and Cohorts

  • Experimental: Ivermectin
    • Ivermectin 200mcg/kg single dose, maximum dose 18mg
  • Placebo Comparator: Placebo
    • Inactive medication tablets indistinguishable from ivermectin tablets

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with hospitalization criteria
    • Time Frame: 30 days
    • Proportion of patients with hospitalization criteria at day 30

Secondary Measures

  • 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
  • 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
  • Drug-related adverse events
    • Time Frame: 30 days
    • Proportion of patients with ivermectin adverse events up to day 30
  • Levels of IgG for SARS-CoV-2
    • Time Frame: 30-60 days
    • Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Nacional de Asunción
  • Collaborator
    • Consejo Nacional de Ciencias y Tecnologia, Paraguay
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Gabriela Avila, MD, MSc, PhD, +59521683930, mavila@med.una.py

References

López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, Díazgranados JA, Oñate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendaño 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 Mar 4. doi: 10.1001/jama.2021.3071. [Epub ahead of print]

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, Giráldez M, Mota JS, Yuste JR, Azanza JR, Fernández M, Reina G, Dobaño 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.

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