Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO) (SAINTBO)
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Efficacy, Safety, Ivermectin
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Universidad Mayor de San Simón
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ivermectin
Placebo Comparator
Participants will receive a single 600 µg / kg dose of ivermectin.
Participants will receive a single dose of placebo.