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.
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.
Participants will be randomized to receive a single dose of 400 mcg/kg ivermectin or a
placebo. The randomization code will be generated by the trial statistician using blocks that
ensure balance between the groups.
The allocation will be made by the investigator after obtaining informed consent, and
confirmation of fulfillment of all inclusion and none of the exclusion criteria. The
investigational product will be administered by a researcher not involved in patient care or
participant follow up.
Participants will remain in the trial for a period of 28 days.
In the interests of public health and containing transmission of infection, trial visits will
be conducted in the participant's home by a clinical trial team comprising nursing and
medical members.
Subsequent visits will be to assess clinical and laboratory parameters.
A final study visit will be made for participants who withdraw prematurely from the study or
are withdrawn by the investigator.
Drug: Ivermectin
Single dose of STROMECTOL® tablets at 400mcg/kg
Other Name: Stromectol
Drug: Placebo
Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
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.
Clinica Universidad de Navarra
Pamplona, Navarra, Spain
Carlos J Chaccour, MD PhD, Principal Investigator
Clinica Universidad de Navarra and Barcelona Institute of Global Health