A research institute in Paraguay conducts a clinical trial of Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial.

Universidad Nacional de Asunción is recruiting patients for the clinical trial of Efficacy of Ivermectin in Outpatients With Non-severe COVID-19.

 

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.

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.

Triple (Participant, Investigator, Outcomes Assessor).

The researchers plan that November 17, 2020 will be the study start date. The indicative completion of the clinical trial will be expected in May 30, 2021.

Among primary outcome measures are the Proportion of patients with hospitalization criteria and Proportion of patients with hospitalization criteria at day 30.

The study will take place at the Facultad de Ciencias Médicas - Universidad Nacional de Asunción, Asunción, Paraguay.

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 can be enrolled into this research.

There are a number of conditions that do not allow participation, such as:

  • 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.

The page dedicated to this clinical trial can be found here:  https://ichgcp.net/clinical-trials-registry/NCT04834115

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