Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial
Condition: Covid-19; Coronavirus Infection; SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Intervention: Ivermectin; Placebo
Intervention description: Single dose of STROMECTOL® tablets at 400mcg/kg; Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
Intervention MeSH terms: Ivermectin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Masking description: Double blind
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: ivermectin

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.
    

Eligibility 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.