Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial

• Status: Completed
• Trial end date: 2020-10-09
• Target enrollment: 0
• Participant gender: All

Summary

SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborator: Barcelona Institute for Global Health
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

1. Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.

2. Residents of the Pamplona basin ("Cuenca de Pamplona")

3. The patient should be aged 18 to 59 years

4. Negative pregnancy test for women of child bearing age*

5. The patient or his/her representative, have given consent to participate in the study.

6. The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)

• Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)

Exclusion Criteria:

1. Known history of Ivermectin allergy

2. Hypersensitivity to any component of Stromectol®

3. COVID-19 Pneumonia

• Diagnosed by the attending physician

• Identified in a chest X-ray

4. Fever or cough present for more than 48 hours

5. Positive IgG against SARS-CoV-2 by rapid test

6. Age under 18 or over 60 years

7. The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator):

• Immunosuppression

• Chronic Obstructive Pulmonary Disease

• Diabetes

• Hypertension

• Obesity

• Acute or chronic renal failure

• History of coronary disease

• History of cerebrovascular disease

• Current neoplasm

8. Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)

9. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.