Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial (SAINT)
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|ClinicalTrials.gov Identifier: NCT04390022|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid-19 Coronavirus Infection SARS-CoV-2 Infection||Drug: Ivermectin Drug: Placebo||Phase 2|
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A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|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|
|Official Title:||Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission|
|Actual Study Start Date :||July 31, 2020|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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 Name: 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.
- 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
- 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)
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
|Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31108|
|Principal Investigator:||Carlos J Chaccour, MD PhD||Clinica Universidad de Navarra and Barcelona Institute of Global Health|