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| Name | Class |
|---|---|
| Barcelona Institute for Global Health | OTHER |
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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.
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A final study visit will be made for participants who withdraw prematurely from the study or are withdrawn by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Active Comparator | Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit. |
|
| Placebo | Placebo Comparator | Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | Single dose of STROMECTOL® tablets at 400mcg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Median Viral Load | 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 |
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Inclusion Criteria:
Patients diagnosed with COVID-19 in the emergency room of the ClÃnica 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)
Exclusion Criteria:
Known history of Ivermectin allergy
Hypersensitivity to any component of Stromectol®
COVID-19 Pneumonia
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):
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.
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| Name | Affiliation | Role |
|---|---|---|
| Carlos J Chaccour, MD PhD | Clinica Universidad de Navarra and Barcelona Institute of Global Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Pamplona | Navarre | 31108 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33495752 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ivermectin | Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit. (Single dose of STROMECTOL® tablets at 400mcg/kg) |
| FG001 | Placebo | Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit. (Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ivermectin | Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit. (Single dose of STROMECTOL® tablets at 400mcg/kg) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 7 days post-treatment |
|
28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ivermectin | Participants on this arm received a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit. (Single dose of STROMECTOL® tablets at 400mcg/kg) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Chaccour | Barcelona Institute for Global Health | 0034666293112 | carlos.chaccour@isglobal.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2020 | Dec 4, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 12, 2020 | Dec 4, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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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.
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Double blind
| Placebo | Drug | Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care. |
|
Proportion of patients with fever and cough
| Days 4, 7, 14 and 21 |
| Seroconversion at Day 21 | Proportion of participants with positive IgG at day 21 | Up to and including day 21 |
| Proportion of Drug-related Adverse Events | Proportion of drug-related adverse events | 7 days post treatment |
| 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] | Up to and including day 28 |
| 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] | Up to and including day 7 |
| 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] | Up to and including day 7 |
| 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] | Up to and including day 28 |
Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit.
(Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| Any symptoms | Count of Participants | Participants |
|
| Earliest start of any symptom | Presence of symptoms as well as their onset date was self-reported by each patient in the baseline visit. | Median | Inter-Quartile Range | hours |
|
| Fever | Count of Participants | Participants |
|
| Earliest start of fever | Presence of fever as well as its onset date was self-reported by each patient in the baseline visit. | Only patients with reported fever | Median | Inter-Quartile Range | hours |
|
| Cough | Count of Participants | Participants |
|
| Earliest start of cough | Presence of cough as well as its onset date was self-reported by each patient in the baseline visit. | Only patients with cough. | Median | Inter-Quartile Range | hours |
|
| CRP | Median | Inter-Quartile Range | mg/dL |
|
| Ferritin | Median | Inter-Quartile Range | mg/dL |
|
| IL-6 | Median | Inter-Quartile Range | pg/mL |
|
| D-Dimer | Median | Inter-Quartile Range | ng/mL |
|
|
|
| Secondary | Median Viral Load | Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N). | Posted | Median | Inter-Quartile Range | copies/mL | Baseline and on days 4, 7, 14 and 21 |
|
|
|
| Secondary | Fever and Cough Progression | Proportion of patients with fever and cough | Posted | Count of Participants | Participants | Days 4, 7, 14 and 21 |
|
|
|
| Secondary | Seroconversion at Day 21 | Proportion of participants with positive IgG at day 21 | Posted | Count of Participants | Participants | Up to and including day 21 |
|
|
|
| Secondary | Proportion of Drug-related Adverse Events | Proportion of drug-related adverse events | Posted | Count of Participants | Participants | 7 days post treatment |
|
|
|
| Secondary | 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] | Not Posted | Up to and including day 28 | Participants |
| Secondary | 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] | Not Posted | Up to and including day 7 | Participants |
| Secondary | 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] | Not Posted | Up to and including day 7 | Participants |
| Secondary | 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] | Not Posted | Up to and including day 28 | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Placebo | Participants on this arm received a single, oral dose of placebo tablets at the enrollment visit. (Placebo tablets did not match ivermectin but they were administered by staff not involved in the clinical care) | 0 | 12 | 0 | 12 | 5 | 12 |
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Ferritin elevation | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute pharyngitis (tonsillitis) | Infections and infestations | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypochromic Microcytic Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dorsal discomfort of a mechanical nature | Cardiac disorders | Systematic Assessment |
|
| Worsening of acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abdominal bacterial translocation | Infections and infestations | Systematic Assessment |
|
| Hematoma | General disorders | Systematic Assessment |
|
| D-Dimer increase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cold Sore | Cardiac disorders | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
|
| Grade II burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Gene E - day 7 |
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| Gene E - day 14 |
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| Gene E - day 21 |
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| Gene N - day 1 |
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| Gene N - day 4 |
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| Gene N - day 7 |
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| Gene N - day 14 |
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| Gene N - day 21 |
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| Fever - Day 14 |
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| Fever - Day 21 |
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| Cough - Day 4 |
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| Cough - Day 7 |
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| Cough - Day 14 |
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| Cough - Day 21 |
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