Trial Outcomes & Findings for Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial (NCT NCT04390022)
NCT ID: NCT04390022
Last Updated: 2020-12-17
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
7 days post-treatment
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ivermectin
n=12 Participants
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)
|
Placebo
n=12 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=12 Participants
|
26 years
n=12 Participants
|
26 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
12 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index
|
23.5 kg/m^2
n=12 Participants
|
22.9 kg/m^2
n=12 Participants
|
22.9 kg/m^2
n=24 Participants
|
|
Any symptoms
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
24 Participants
n=24 Participants
|
|
Earliest start of any symptom
|
24 hours
n=12 Participants
|
48 hours
n=12 Participants
|
48 hours
n=24 Participants
|
|
Fever
|
7 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
16 Participants
n=24 Participants
|
|
Earliest start of fever
|
24 hours
n=7 Participants • Only patients with reported fever
|
24 hours
n=9 Participants • Only patients with reported fever
|
24 hours
n=16 Participants • Only patients with reported fever
|
|
Cough
|
4 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=24 Participants
|
|
Earliest start of cough
|
24 hours
n=4 Participants • Only patients with cough.
|
10 hours
n=2 Participants • Only patients with cough.
|
18 hours
n=6 Participants • Only patients with cough.
|
|
CRP
|
0.3 mg/dL
n=12 Participants
|
0.3 mg/dL
n=12 Participants
|
0.3 mg/dL
n=24 Participants
|
|
Ferritin
|
165.0 mg/dL
n=12 Participants
|
156.1 mg/dL
n=12 Participants
|
160.9 mg/dL
n=24 Participants
|
|
IL-6
|
6.5 pg/mL
n=12 Participants
|
4.5 pg/mL
n=12 Participants
|
5.3 pg/mL
n=24 Participants
|
|
D-Dimer
|
295 ng/mL
n=12 Participants
|
280 ng/mL
n=12 Participants
|
285 ng/mL
n=24 Participants
|
PRIMARY outcome
Timeframe: 7 days post-treatmentProportion 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).
Outcome measures
| Measure |
Ivermectin
n=12 Participants
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)
|
Placebo
n=12 Participants
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)
|
|---|---|---|
|
Proportion of Patients With a Positive SARS-CoV-2 PCR
PCR positivity (gene N)
|
12 Participants
|
12 Participants
|
|
Proportion of Patients With a Positive SARS-CoV-2 PCR
PCR positivity (gene E)
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and on days 4, 7, 14 and 21Quantitative and semi-quantitative PCR in nasopharyngeal swab. PCRs were performed using two target genes (E and N).
Outcome measures
| Measure |
Ivermectin
n=12 Participants
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)
|
Placebo
n=12 Participants
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)
|
|---|---|---|
|
Median Viral Load
Gene E - day 1
|
16850000 copies/mL
Interval 5915000.0 to 385250000.0
|
26700000 copies/mL
Interval 8325000.0 to 423500000.0
|
|
Median Viral Load
Gene E - day 4
|
161000 copies/mL
Interval 2820.0 to 878000.0
|
493500 copies/mL
Interval 103700.0 to 9910000.0
|
|
Median Viral Load
Gene E - day 7
|
1018 copies/mL
Interval 92.0 to 15445.0
|
23550 copies/mL
Interval 709.0 to 226500.0
|
|
Median Viral Load
Gene N - day 1
|
367000000 copies/mL
Interval 18350000.0 to 9280000000.0
|
327500000 copies/mL
Interval 58300000.0 to 6740000000.0
|
|
Median Viral Load
Gene N - day 4
|
269000 copies/mL
Interval 1885.0 to 1046500.0
|
2194500 copies/mL
Interval 73150.0 to 37100000.0
|
|
Median Viral Load
Gene N - day 7
|
2255 copies/mL
Interval 938.0 to 34650.0
|
36800 copies/mL
Interval 4510.0 to 630500.0
|
|
Median Viral Load
Gene N - day 14
|
86 copies/mL
Interval 0.0 to 1235.0
|
75 copies/mL
Interval 24.0 to 710.0
|
|
Median Viral Load
Gene N - day 21
|
0 copies/mL
Interval 0.0 to 67.0
|
107 copies/mL
Interval 0.0 to 183.0
|
|
Median Viral Load
Gene E - day 14
|
7 copies/mL
Interval 0.0 to 42.0
|
30 copies/mL
Interval 1.0 to 50.0
|
|
Median Viral Load
Gene E - day 21
|
1 copies/mL
Interval 0.0 to 9.0
|
0 copies/mL
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Days 4, 7, 14 and 21Proportion of patients with fever and cough
Outcome measures
| Measure |
Ivermectin
n=12 Participants
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)
|
Placebo
n=12 Participants
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)
|
|---|---|---|
|
Fever and Cough Progression
Fever - Day 4
|
0 Participants
|
0 Participants
|
|
Fever and Cough Progression
Fever - Day 7
|
1 Participants
|
0 Participants
|
|
Fever and Cough Progression
Fever - Day 14
|
0 Participants
|
0 Participants
|
|
Fever and Cough Progression
Fever - Day 21
|
0 Participants
|
0 Participants
|
|
Fever and Cough Progression
Cough - Day 4
|
5 Participants
|
6 Participants
|
|
Fever and Cough Progression
Cough - Day 7
|
5 Participants
|
5 Participants
|
|
Fever and Cough Progression
Cough - Day 14
|
1 Participants
|
3 Participants
|
|
Fever and Cough Progression
Cough - Day 21
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to and including day 21Proportion of participants with positive IgG at day 21
Outcome measures
| Measure |
Ivermectin
n=12 Participants
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)
|
Placebo
n=12 Participants
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)
|
|---|---|---|
|
Seroconversion at Day 21
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 7 days post treatmentProportion of drug-related adverse events
Outcome measures
| Measure |
Ivermectin
n=12 Participants
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)
|
Placebo
n=12 Participants
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)
|
|---|---|---|
|
Proportion of Drug-related Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to and including day 28Levels 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. \[Results not yet available\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to and including day 7Frequency (% 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. \[Results not yet available\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to and including day 7Frequency 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. \[Results not yet available\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to and including day 28Concentration (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). \[Results not yet available\]
Outcome measures
Outcome data not reported
Adverse Events
Ivermectin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ivermectin
n=12 participants at risk
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)
|
Placebo
n=12 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Nervous system disorders
Insomnia
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Blood and lymphatic system disorders
Ferritin elevation
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Infections and infestations
Acute pharyngitis (tonsillitis)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Blood and lymphatic system disorders
Hypochromic Microcytic Anemia
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Cardiac disorders
Dorsal discomfort of a mechanical nature
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Skin and subcutaneous tissue disorders
Worsening of acne
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Infections and infestations
Abdominal bacterial translocation
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
General disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Blood and lymphatic system disorders
D-Dimer increase
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Cardiac disorders
Cold Sore
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Gastrointestinal disorders
Odynophagia
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
|
Skin and subcutaneous tissue disorders
Grade II burn
|
0.00%
0/12 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
8.3%
1/12 • Number of events 1 • 28 days
Adverse events were assessed at each study visit (days 1, 4, 7, 14, 21 and 28)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place