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

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ClinicalTrials.gov Identifier: NCT04390022
Recruitment Status : Completed
First Posted : May 15, 2020
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Barcelona Institute for Global Health
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Covid-19
Coronavirus Infection
SARS-CoV-2 Infection
Interventions Drug: Ivermectin
Drug: Placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description

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)

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)

Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Ivermectin Placebo Total
Hide Arm/Group Description

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)

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)

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
26
(19 to 36)
26
(21 to 44)
26
(20 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
5
  41.7%
7
  58.3%
12
  50.0%
Male
7
  58.3%
5
  41.7%
12
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Body mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 24 participants
23.5
(19.6 to 27.8)
22.9
(21.0 to 24.8)
22.9
(20.6 to 26.1)
Any symptoms  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
12
 100.0%
12
 100.0%
24
 100.0%
Earliest start of any symptom   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 12 participants 12 participants 24 participants
24
(24 to 48)
48
(36 to 48)
48
(24 to 48)
[1]
Measure Description: Presence of symptoms as well as their onset date was self-reported by each patient in the baseline visit.
Fever  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
7
  58.3%
9
  75.0%
16
  66.7%
Earliest start of fever   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 7 participants 9 participants 16 participants
24
(12 to 24)
24
(24 to 48)
24
(15 to 36)
[1]
Measure Description: Presence of fever as well as its onset date was self-reported by each patient in the baseline visit.
[2]
Measure Analysis Population Description: Only patients with reported fever
Cough  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
4
  33.3%
2
  16.7%
6
  25.0%
Earliest start of cough   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 4 participants 2 participants 6 participants
24
(16 to 36)
10
(8 to 12)
18
(8 to 24)
[1]
Measure Description: Presence of cough as well as its onset date was self-reported by each patient in the baseline visit.
[2]
Measure Analysis Population Description: Only patients with cough.
CRP  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
0.3
(0.2 to 0.8)
0.3
(0.2 to 0.6)
0.3
(0.2 to 0.7)
Ferritin  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
165.0
(95.8 to 241.3)
156.1
(103.1 to 223.0)
160.9
(101.8 to 223.0)
IL-6  
Median (Inter-Quartile Range)
Unit of measure:  pg/mL
Number Analyzed 12 participants 12 participants 24 participants
6.5
(5.1 to 9.6)
4.5
(3.0 to 6.5)
5.3
(3.8 to 8.2)
D-Dimer  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 12 participants 12 participants 24 participants
295
(270 to 420)
280
(270 to 315)
285
(270 to 365)
1.Primary Outcome
Title Proportion of Patients With a Positive SARS-CoV-2 PCR
Hide Description 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).
Time Frame 7 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
PCR positivity (gene N)
12
 100.0%
12
 100.0%
PCR positivity (gene E)
11
  91.7%
12
 100.0%
2.Secondary Outcome
Title Median Viral Load
Hide Description Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).
Time Frame Baseline and on days 4, 7, 14 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: copies/mL
Gene E - day 1
16850000
(5915000 to 385250000)
26700000
(8325000 to 423500000)
Gene E - day 4
161000
(2820 to 878000)
493500
(103700 to 9910000)
Gene E - day 7
1018
(92 to 15445)
23550
(709 to 226500)
Gene E - day 14
7
(0 to 42)
30
(1 to 50)
Gene E - day 21
1
(0 to 9)
0
(0 to 16)
Gene N - day 1
367000000
(18350000 to 9280000000)
327500000
(58300000 to 6740000000)
Gene N - day 4
269000
(1885 to 1046500)
2194500
(73150 to 37100000)
Gene N - day 7
2255
(938 to 34650)
36800
(4510 to 630500)
Gene N - day 14
86
(0 to 1235)
75
(24 to 710)
Gene N - day 21
0
(0 to 67)
107
(0 to 183)
3.Secondary Outcome
Title Fever and Cough Progression
Hide Description Proportion of patients with fever and cough
Time Frame Days 4, 7, 14 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Fever - Day 4
0
   0.0%
0
   0.0%
Fever - Day 7
1
   8.3%
0
   0.0%
Fever - Day 14
0
   0.0%
0
   0.0%
Fever - Day 21
0
   0.0%
0
   0.0%
Cough - Day 4
5
  41.7%
6
  50.0%
Cough - Day 7
5
  41.7%
5
  41.7%
Cough - Day 14
1
   8.3%
3
  25.0%
Cough - Day 21
1
   8.3%
3
  25.0%
4.Secondary Outcome
Title Seroconversion at Day 21
Hide Description Proportion of participants with positive IgG at day 21
Time Frame Up to and including day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
12
 100.0%
5.Secondary Outcome
Title Proportion of Drug-related Adverse Events
Hide Description Proportion of drug-related adverse events
Time Frame 7 days post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Levels of IgG, IgM and IgA
Hide Description

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]

Time Frame Up to and including day 28
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Frequency of Innate Immune Cells
Hide Description

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]

Time Frame Up to and including day 7
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells
Hide Description

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]

Time Frame Up to and including day 7
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Results From Cytokine Human Magnetic 30-Plex Panel
Hide Description

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]

Time Frame Up to and including day 28
Outcome Measure Data Not Reported
Time Frame 28 days
Adverse Event Reporting Description Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
 
Arm/Group Title Ivermectin Placebo
Hide Arm/Group Description

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)

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)

All-Cause Mortality
Ivermectin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Ivermectin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ivermectin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      5/12 (41.67%)    
Blood and lymphatic system disorders     
Leukopenia   0/12 (0.00%)  0 1/12 (8.33%)  1
Ferritin elevation   0/12 (0.00%)  0 1/12 (8.33%)  1
Hypochromic Microcytic Anemia   1/12 (8.33%)  1 0/12 (0.00%)  0
D-Dimer increase   1/12 (8.33%)  1 0/12 (0.00%)  0
Cardiac disorders     
Sinus tachycardia   0/12 (0.00%)  0 1/12 (8.33%)  1
Dorsal discomfort of a mechanical nature   1/12 (8.33%)  1 0/12 (0.00%)  0
Cold Sore   1/12 (8.33%)  1 0/12 (0.00%)  0
Gastrointestinal disorders     
Odynophagia   1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders     
Hematoma   1/12 (8.33%)  1 1/12 (8.33%)  1
Infections and infestations     
Acute pharyngitis (tonsillitis)   0/12 (0.00%)  0 1/12 (8.33%)  1
Abdominal bacterial translocation   0/12 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders     
Insomnia   0/12 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders     
Worsening of acne   1/12 (8.33%)  1 0/12 (0.00%)  0
Grade II burn   0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carlos Chaccour
Organization: Barcelona Institute for Global Health
Phone: 0034666293112
EMail: carlos.chaccour@isglobal.org
Layout table for additonal information
Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT04390022    
Other Study ID Numbers: SAINT
First Submitted: May 7, 2020
First Posted: May 15, 2020
Results First Submitted: December 9, 2020
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020