Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms (NCT NCT04407507)
NCT ID: NCT04407507
Last Updated: 2021-05-21
Results Overview
The subject is considered to have progressed to severe illness when one or more of the following criteria are present: 1. Breathing difficulty (≥30 breaths per minute); 2. Resting oxygen saturation ≤93%; 3. Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
14 days
Results posted on
2021-05-21
Participant Flow
Participant milestones
| Measure |
Ivermectin
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ivermectin
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms
Baseline characteristics by cohort
| Measure |
Ivermectin
n=33 Participants
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
n=33 Participants
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Continuous
|
40.24 years
STANDARD_DEVIATION 14.48 • n=93 Participants
|
36.82 years
STANDARD_DEVIATION 13.90 • n=4 Participants
|
38.53 years
STANDARD_DEVIATION 14.19 • n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
33 participants
n=93 Participants
|
33 participants
n=4 Participants
|
66 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Participants With a Disease Control Status Defined as no Disease Progression to Severe, 3 subjects of the Ivermectin arm group and 7 of the placebo were excluded of the efficacy analysis due to wrong criteria of inclusion (3 of ivermectin and 6 from placebo) and withdrawal of consent (1 in placebo).
The subject is considered to have progressed to severe illness when one or more of the following criteria are present: 1. Breathing difficulty (≥30 breaths per minute); 2. Resting oxygen saturation ≤93%; 3. Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.
Outcome measures
| Measure |
Ivermectin
n=30 Participants
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
n=26 Participants
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
Participants With a Disease Control Status Defined as no Disease Progression to Severe.
|
30 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: days 1, 5 and 14Population: Only positive subjects are reported, since Ct is not reported in negative subjects, therefore there is no data available to analyze this criterion, as negative subjects are reported, the values for analysis decrease.
To determine viral load indirectly, the Ct value of the SARS-COV-2 gene N was used on days 1, 5 and 14 of treatment, considering values greater than 37.5 as negative.
Outcome measures
| Measure |
Ivermectin
n=30 Participants
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
n=26 Participants
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
SARS-CoV-2 Viral Load, at 5 and 14 Days
Day 1
|
26.17 Cycle threshold
Standard Deviation 6.36
|
23.3 Cycle threshold
Standard Deviation 5.15
|
|
SARS-CoV-2 Viral Load, at 5 and 14 Days
Day 5
|
30.52 Cycle threshold
Standard Deviation 4.21
|
28.5 Cycle threshold
Standard Deviation 3.73
|
|
SARS-CoV-2 Viral Load, at 5 and 14 Days
Day 14
|
33.74 Cycle threshold
Standard Deviation 4.77
|
32.94 Cycle threshold
Standard Deviation 4.74
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Subjects were asked to answer a symptoms dairy during 14 days, where they recorded the presence of the following symptoms; fever, cough, muscular pain, fatigue, breath difficulty, headache, diarrhea, palpitations, expectoration and "Other", in the other question several subjects answer hypogeusia/ageusia, hyposmia/anosmia and backpain.
Subjects were asked to answer a symptoms dairy during 14 days, where they recorded the presence of the following symptoms; fever, cough, muscular pain, fatigue, breath difficulty, headache, diarrhea, palpitations, expectoration and "Other", in the other question several subjects answer hypogeusia/ageusia, hyposmia/anosmia and backpain. The total of days anaylized were considered as 100%; 364 days for placebo patients(26 subjects x 14 days), and 420 for ivermectin subjects (30 subjects x 14 days), then the number of days reported correspond to de % of days when symptom was present.
Outcome measures
| Measure |
Ivermectin
n=30 Participants
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
n=26 Participants
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Fever
|
7.67 percentage of days
|
5.44 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Cough
|
51.7 percentage of days
|
34.1 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Muscular pain
|
29.5 percentage of days
|
24.6 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Fatigue
|
45.4 percentage of days
|
38.1 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Breath difficulty
|
16.7 percentage of days
|
14.9 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Headache
|
32.3 percentage of days
|
26.9 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Palpitations
|
13 percentage of days
|
9.74 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Expectoration
|
25.7 percentage of days
|
17.5 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Diarrhea
|
13 percentage of days
|
7.16 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Hypogeusia/ageusia
|
18.9 percentage of days
|
8.31 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Hyposmia/anosmia
|
19.4 percentage of days
|
10.9 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Backpain
|
1.79 percentage of days
|
0.57 percentage of days
|
|
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Other
|
28.6 percentage of days
|
14.3 percentage of days
|
Adverse Events
Ivermectin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ivermectin
n=33 participants at risk
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
n=33 participants at risk
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
Nervous system disorders
HT Central nervous system and spinal cord infections
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
Other adverse events
| Measure |
Ivermectin
n=33 participants at risk
Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Ivermectin: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
Placebo
n=33 participants at risk
Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days
Placebo: Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
HLT RASH
|
3.0%
1/33 • Number of events 1 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Renal and urinary disorders
LLT Cystitis
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
Renal and urinary disorders
HLT Urinary tract infections
|
6.1%
2/33 • Number of events 2 • 21 days
|
0.00%
0/33 • 21 days
|
|
Skin and subcutaneous tissue disorders
HLGT Epidermal and dermal diseases
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
General disorders
PF Vertigo
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
Psychiatric disorders
HLGT anxiety disorders and symptoms
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
Gastrointestinal disorders
HLGT Inflammatory gastrointestinal diseases
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
Ear and labyrinth disorders
LLT Otitis
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
Respiratory, thoracic and mediastinal disorders
LLT pharyngitis
|
3.0%
1/33 • Number of events 1 • 21 days
|
0.00%
0/33 • 21 days
|
|
Respiratory, thoracic and mediastinal disorders
HLT Nasal congestion and inflammation
|
3.0%
1/33 • Number of events 1 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Vascular disorders
LLT Hypertension
|
3.0%
1/33 • Number of events 1 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Metabolism and nutrition disorders
HLGT Glucose metabolism disorders (including diabetes mellitus)
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Blood and lymphatic system disorders
SOC Blood and lymphatic system disorders
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Musculoskeletal and connective tissue disorders
HLT Musculoskeletal pain and discomfort
|
0.00%
0/33 • 21 days
|
6.1%
2/33 • Number of events 2 • 21 days
|
|
Gastrointestinal disorders
LLT acidity
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Endocrine disorders
LLT elevated Lipase
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Gastrointestinal disorders
LLT Nausea
|
0.00%
0/33 • 21 days
|
6.1%
2/33 • Number of events 2 • 21 days
|
|
Skin and subcutaneous tissue disorders
SOC Skin and subcutaneous tissue disorders
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Gastrointestinal disorders
PT Acid Peptic Disease
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Musculoskeletal and connective tissue disorders
LLT Back pain
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
General disorders
LLT Dizziness
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Vascular disorders
LLT Tachycardia
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
|
Respiratory, thoracic and mediastinal disorders
LLT Pneumonia
|
0.00%
0/33 • 21 days
|
3.0%
1/33 • Number of events 1 • 21 days
|
Additional Information
Carmen de la Rocha
Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V
Phone: 523320028697
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place