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| Name | Class |
|---|---|
| Consejo Nacional de Ciencias y Tecnologia, Paraguay | UNKNOWN |
| Ministerio de Salud Pública y Bienestar Social, Paraguay | UNKNOWN |
| Centro de información y recursos para el desarrollo, Paraguay | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | Ivermectin 200mcg/kg single dose, maximum dose 18mg |
|
| Placebo | Placebo Comparator | Inactive medication tablets indistinguishable from ivermectin tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Tablets | Drug | Oral ivermectin at a one time dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with hospitalization criteria | Proportion of patients with hospitalization criteria at day 30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with COVID-19 signs and symptoms | Proportion of patients with COVID-19 signs and symptoms up to day 14 | 14 days |
| Proportion of cohabitants who had COVID-19 after the index case |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Avila, MD, MSc, PhD | Contact | +59521683930 | 324 | mavila@med.una.py |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Ciencias Médicas - Universidad Nacional de Asunción | Recruiting | Asunción | 111421 | Paraguay |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33662102 | Background | 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. | |
| 32251768 |
| Label | URL |
|---|---|
| National Council of Science and Technology, Paraguay | View source |
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The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D003141 | Communicable Diseases |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Centro para el Desarrollo de la Investigación CientÃfica, CEDIC, Paraguay | UNKNOWN |
| Instituto Desarrollo, Paraguay | UNKNOWN |
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.
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Triple (Participant, Investigator, Outcomes Assessor)
| Placebo |
| Other |
Oral placebo at a one time dose |
|
Proportion of cohabitants who had COVID-19 after the index case up to day 30
| 30 days |
| Drug-related adverse events | Proportion of patients with ivermectin adverse events up to day 30 | 30 days |
| Levels of IgG for SARS-CoV-2 | Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay | 30-60 days |
| Background |
| 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. |
| 32513289 | Background | 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. |
| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |