SAINT-PERU is a triple-blinded, randomized placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.
SAINT is a triple-blinded, randomized placebo-controlled trial with two parallel arms to
evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with
SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.
The planned sample size is 186 SARS-CoV-2 PCR positive patients: 93 patients to treatment and
93 to the placebo group. Participants will be randomized to receive one dose of 300 mcg/kg
ivermectin or placebo daily for three consecutive days. The epidemiologist will generate a
list of correlative numbers, in randomized blocks of size 4, with the assignment to the
treatment groups (a and b). The randomization list will be kept in an encrypted file
accessible only to the trial statistician. This list will be handed directly to the
pharmacist. Independently, the principal investigator will randomly assign the intervention
(ivermectin) to one of the two groups (a or b) by tossing a coin, and will inform the
pharmacist of the result of this process. The pharmacist will prepare and label the treatment
vials according to the randomization list prepared by the epidemiologist and the treatment
assignment given by the principal investigator. Eligible patients will be allocated in a 1:1
ratio using this randomization list.
Participants are expected to remain in the trial for a period of 21 days.
In the interests of public health and containing transmission of infection, follow-up visits
will be conducted by the trial medical staff at the participant's home or at a hospital in
case of hospitalization.
Follow-up visits will assess clinical and laboratory parameters of the patients.
Drug: Ivermectin
One daily dose of NOXAL-Ivermectin Oral Solution (6 mg/mL) at 300mcg/kg for three (3) consecutive days. A weight-equivalence table will be used to determine each participant´s dose (number of oral drops/day).
Other Name: Noxal
Drug: Placebo
The placebo presentation will be an oral drop solution undistinguishable from ivermectin, but without this device pharmaceutical ingredient.
Inclusion Criteria:
1. Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more
than 96 hours.
2. 18 years or older.
3. No use of ivermectin prior to the study.
4. No known history of ivermectin allergy.
5. The patient can give his consent to take part in the study.
6. Not 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.
Exclusion Criteria:
1. COVID-19 pneumonia
- Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles)
2. Positive pregnancy test for women of childbearing age*
3. Positive IgG against SARS-CoV-2 by rapid diagnostic test.
4. Negative SARS-CoV-2 PCR from a nasopharyngeal swab.
- Women of child bearing age may participate if they use a safe contraceptive
method for the entire period of the study. 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)
Hospital Nacional Cayetano Heredia
Lima, Peru