Coronavirus Infection, Covid19
Conditions
Keywords
Ivermectin, Communicable Diseases, Respiratory Tract Infections
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.
Interventions
Oral ivermectin at a one time dose
OTHERPlacebo
Oral placebo at a one time dose
Sponsors
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
Universidad Nacional de Asunción
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple (Participant, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with hospitalization criteria | 30 days | Proportion of patients with hospitalization criteria at day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with COVID-19 signs and symptoms | 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 | 30 days | Proportion of cohabitants who had COVID-19 after the index case up to day 30 |
| Drug-related adverse events | 30 days | Proportion of patients with ivermectin adverse events up to day 30 |
| Levels of IgG for SARS-CoV-2 | 30-60 days | Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay |
Countries
Paraguay
Contacts
Primary ContactGabriela Avila, MD, MSc, PhD
Outcome results
None listed