Status:
UNKNOWN
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19
Lead Sponsor:
Universidad Nacional de Asunción
Collaborating Sponsors:
Consejo Nacional de Ciencias y Tecnologia, Paraguay
Ministerio de Salud Pública y Bienestar Social, Paraguay
Conditions:
Covid19
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 randomize...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04834115
Start Date
November 17 2020
End Date
May 30 2021
Last Update
April 6 2021
Active Locations (1)
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1
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Asunción, Paraguay, 111421