Clinical trial NCT04834115: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
Coronavirus Infection
Keywords: Ivermectin
Communicable Diseases
Respiratory Tract Infections
Lead sponsor: Universidad Nacional de Asunción
Sponsor class: OTHER
Collaborators: name: Consejo Nacional de Ciencias y Tecnologia, Paraguay
name: Ministerio de Salud Pública y Bienestar Social, Paraguay
name: Centro de información y recursos para el desarrollo, Paraguay
name: Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay
name: Instituto Desarrollo, Paraguay
First posted: 2021-04-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients with hospitalization criteria
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of patients with COVID-19 signs and symptoms
timeFrame: 14 days
measure: Proportion of cohabitants who had COVID-19 after the index case
timeFrame: 30 days
measure: Drug-related adverse events
timeFrame: 30 days
measure: Levels of IgG for SARS-CoV-2
timeFrame: 30-60 days
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Study officials:
References:
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.
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.
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.