- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390022
Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial (SAINT)
Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission
Study Overview
Status
Conditions
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A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Navarra
-
Pamplona, Navarra, Spain, 31108
- Clinica Universidad de Navarra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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:
|
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
Collaborators
Investigators
- Principal Investigator: Carlos J Chaccour, MD PhD, Clinica Universidad de Navarra and Barcelona Institute of Global Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Coronavirus Infections
- Infections
- Communicable Diseases
- Anti-Infective Agents
- Antiparasitic Agents
- Ivermectin
Other Study ID Numbers
- SAINT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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