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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

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.

Condition or disease Intervention/treatment Phase
Covid-19 Coronavirus Infection SARS-CoV-2 Infection Drug: Ivermectin Drug: Placebo Phase 2

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A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Official Title: Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission
Estimated Study Start Date : May 14, 2020
Estimated Primary Completion Date : August 4, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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.
Drug: Ivermectin
Single dose of STROMECTOL® tablets at 400mcg/kg
Other Name: Stromectol

Placebo Comparator: Placebo
Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.
Drug: Placebo
Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Seroconversion at day 21 [ Time Frame: Up to and including day 21 ]
    Proportion of participants with positive IgG at day 21

  4. Proportion of drug-related adverse events [ Time Frame: 7 days post treatment ]
    Proportion of drug-related adverse events

  5. 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

  6. 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

  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

  8. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390022


Contacts
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Contact: Irene Canales +34948255400 icanales@unav.es

Locations
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Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31108
Contact: Carlos Chaccour, MD    +34722483020    cchaccour@unav.es   
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Barcelona Institute for Global Health
Investigators
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Principal Investigator: Carlos J Chaccour, MD PhD Clinica Universidad de Navarra and Barcelona Institute of Global Health
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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT04390022    
Other Study ID Numbers: SAINT
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
ivermectin
Additional relevant MeSH terms:
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Ivermectin
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiparasitic Agents
Anti-Infective Agents