Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial (SAINT)

Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

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.

Study Overview

Status

Completed

Intervention / Treatment

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A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.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

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Navarra
      • Pamplona, Navarra, Spain, 31108
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivermectin
Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
Single dose of STROMECTOL® tablets at 400mcg/kg
Other Names:
  • Stromectol
Placebo Comparator: Placebo
Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.
Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With a Positive SARS-CoV-2 PCR
Time Frame: 7 days post-treatment
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).
7 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Viral Load
Time Frame: Baseline and on days 4, 7, 14 and 21
Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).
Baseline and on days 4, 7, 14 and 21
Fever and Cough Progression
Time Frame: Days 4, 7, 14 and 21
Proportion of patients with fever and cough
Days 4, 7, 14 and 21
Seroconversion at Day 21
Time Frame: Up to and including day 21
Proportion of participants with positive IgG at day 21
Up to and including day 21
Proportion of Drug-related Adverse Events
Time Frame: 7 days post treatment
Proportion of drug-related adverse events
7 days post treatment
Levels of IgG, IgM and IgA
Time Frame: Up to and including day 28

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]

Up to and including day 28
Frequency of Innate Immune Cells
Time Frame: Up to and including day 7

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]

Up to and including day 7
Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells
Time Frame: Up to and including day 7

Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry.

[Results not yet available]

Up to and including day 7
Results From Cytokine Human Magnetic 30-Plex Panel
Time Frame: Up to and including day 28

Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher).

[Results not yet available]

Up to and including day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carlos J Chaccour, MD PhD, Clinica Universidad de Navarra and Barcelona Institute of Global Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Actual)

September 17, 2020

Study Completion (Actual)

October 9, 2020

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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