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

Clinica Universidad de Navarra, Universidad de Navarra24 enrolled

Overview

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 A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Covid-19 Coronavirus Infection SARS-CoV-2 Infection

Interventions

IvermectinDRUG

Single dose of STROMECTOL® tablets at 400mcg/kg

PlaceboDRUG

Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Proportion of Patients With a Positive SARS-CoV-2 PCR

Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. PCRs were performed using two target genes (E and N).

Time frame: 7 days post-treatment

Secondary Outcomes

Median Viral Load

Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).

Time frame: Baseline and on days 4, 7, 14 and 21

Fever and Cough Progression

Proportion of patients with fever and cough

Time frame: Days 4, 7, 14 and 21

Seroconversion at Day 21

Proportion of participants with positive IgG at day 21

Time frame: Up to and including day 21

Proportion of Drug-related Adverse Events

Proportion of drug-related adverse events

Time frame: 7 days post treatment

Levels of IgG, IgM and IgA

Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay. \[Results not yet available\]

Time frame: Up to and including day 28

Frequency of Innate Immune Cells

Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry. \[Results not yet available\]

Data from ClinicalTrials.gov

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