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

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ClinicalTrials.gov Identifier: NCT04390022
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Barcelona Institute for Global Health
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 15, 2020
Last Update Posted Date May 21, 2020
Estimated Study Start Date  ICMJE May 14, 2020
Estimated Primary Completion Date August 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • Mean viral load [ Time Frame: Baseline and on days 4, 7, 14 and 21 ]
    Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab
  • Fever and cough progression [ Time Frame: Up to and including day 21 ]
    Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial
  • Seroconversion at day 21 [ Time Frame: Up to and including day 21 ]
    Proportion of participants with positive IgG at day 21
  • Proportion of drug-related adverse events [ Time Frame: 7 days post treatment ]
    Proportion of drug-related adverse events
  • 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
  • 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
  • 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 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial
Official Title  ICMJE Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19
  • Coronavirus Infection
  • SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: Ivermectin
    Single dose of STROMECTOL® tablets at 400mcg/kg
    Other Name: Stromectol
  • Drug: Placebo
    Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
Study Arms  ICMJE
  • Active Comparator: Ivermectin
    Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
    Intervention: Drug: Ivermectin
  • Placebo Comparator: Placebo
    Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date August 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Irene Canales +34948255400 icanales@unav.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04390022
Other Study ID Numbers  ICMJE SAINT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE Barcelona Institute for Global Health
Investigators  ICMJE
Principal Investigator: Carlos J Chaccour, MD PhD Clinica Universidad de Navarra and Barcelona Institute of Global Health
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP