Status:
UNKNOWN
Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO)
Lead Sponsor:
Universidad Mayor de San Simón
Collaborating Sponsors:
Barcelona Institute for Global Health
Université Catholique de Louvain
Conditions:
Covid19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes a respiratory illness (such as the flu) with symptoms such as cough, fever, and, in more severe cases,...
Detailed Description
STUDY DESIGN It is a double-blind, randomized, placebo-controlled superiority trial with two parallel arms. Participants will be randomized to receive a single 600 µg / kg dose of ivermectin or placeb...
Eligibility Criteria
Inclusion
- Confirmed case of COVID-19 in national reference hospitals - COVID sentinel hospitals.
- Male and female patients 18 to 75 years (inclusive) of age.
- Supply of signed and dated informed consent form
- Declared availability to comply with all study procedures and availability for the duration of the study.
- In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment).
- Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study.
- The patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation).
- The patient is able and willing to comply with the requirements of this test protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial.
Exclusion
- Known history of ivermectin allergy
- Hypersensitivity to any component of ivermectin or the excipients of the brand to be used.
- COVID-19 pneumonia
- Diagnosed by the treating physician
- Identified on a chest x-ray
- Fever or cough present for more than 48 hours.
- immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test
- 8\. Recent travel history to loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) 9. Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. Use of critical drugs such as warfarin.
Key Trial Info
Start Date :
May 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04836299
Start Date
May 8 2021
End Date
December 5 2021
Last Update
April 8 2021
Active Locations (1)
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1
Universidad Mayor de San Simón
Cochabamba, Bolivia