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

Primary Purpose

Covid-19, Coronavirus Infection, SARS-CoV-2 Infection

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ivermectin
Placebo
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring ivermectin

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ivermectin

Placebo

Arm Description

Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.

Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Median Viral Load
Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).
Fever and Cough Progression
Proportion of patients with fever and cough
Seroconversion at Day 21
Proportion of participants with positive IgG at day 21
Proportion of Drug-related Adverse Events
Proportion of drug-related adverse events
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]
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]
Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells
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]
Results From Cytokine Human Magnetic 30-Plex Panel
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]

Full Information

First Posted
May 7, 2020
Last Updated
December 10, 2020
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Barcelona Institute for Global Health
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1. Study Identification

Unique Protocol Identification Number
NCT04390022
Brief Title
Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial
Acronym
SAINT
Official Title
Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
September 17, 2020 (Actual)
Study Completion Date
October 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Barcelona Institute for Global Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Coronavirus Infection, SARS-CoV-2 Infection
Keywords
ivermectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin
Arm Type
Active Comparator
Arm Description
Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Stromectol
Intervention Description
Single dose of STROMECTOL® tablets at 400mcg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
Primary Outcome Measure Information:
Title
Proportion of Patients With a Positive SARS-CoV-2 PCR
Description
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 Outcome Measure Information:
Title
Median Viral Load
Description
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
Title
Fever and Cough Progression
Description
Proportion of patients with fever and cough
Time Frame
Days 4, 7, 14 and 21
Title
Seroconversion at Day 21
Description
Proportion of participants with positive IgG at day 21
Time Frame
Up to and including day 21
Title
Proportion of Drug-related Adverse Events
Description
Proportion of drug-related adverse events
Time Frame
7 days post treatment
Title
Levels of IgG, IgM and IgA
Description
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
Title
Frequency of Innate Immune Cells
Description
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]
Time Frame
Up to and including day 7
Title
Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells
Description
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]
Time Frame
Up to and including day 7
Title
Results From Cytokine Human Magnetic 30-Plex Panel
Description
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]
Time Frame
Up to and including day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR. Residents of the Pamplona basin ("Cuenca de Pamplona") The patient should be aged 18 to 59 years Negative pregnancy test for women of child bearing age* The patient or his/her representative, have given consent to participate in the study. 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: Known history of Ivermectin allergy Hypersensitivity to any component of Stromectol® COVID-19 Pneumonia Diagnosed by the attending physician Identified in a chest X-ray Fever or cough present for more than 48 hours Positive IgG against SARS-CoV-2 by rapid test Age under 18 or over 60 years 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 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos J Chaccour, MD PhD
Organizational Affiliation
Clinica Universidad de Navarra and Barcelona Institute of Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31108
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33495752
Citation
Chaccour C, Casellas A, Blanco-Di Matteo A, Pineda I, Fernandez-Montero A, Ruiz-Castillo P, Richardson MA, Rodriguez-Mateos M, Jordan-Iborra C, Brew J, Carmona-Torre F, Giraldez M, Laso E, Gabaldon-Figueira JC, Dobano C, Moncunill G, Yuste JR, Del Pozo JL, Rabinovich NR, Schoning V, Hammann F, Reina G, Sadaba B, Fernandez-Alonso M. The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial. EClinicalMedicine. 2021 Feb;32:100720. doi: 10.1016/j.eclinm.2020.100720. Epub 2021 Jan 19.
Results Reference
derived

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

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