Trial Outcomes & Findings for Prophylactic Ivermectin in COVID-19 Contacts (NCT NCT04422561)
NCT ID: NCT04422561
Last Updated: 2020-08-27
Results Overview
history taking and clinical examination
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
340 participants
Primary outcome timeframe
within 14 days after enrollement
Results posted on
2020-08-27
Participant Flow
Participant milestones
| Measure |
Ivermectin Group
Contacts who will receive prophylactic ivermectin
Ivermectin Tablets:
40-60 kg (15mg/day) 60-80kg (18mg/day) \>80kg (24mg/day)
|
Control Group
Contacts who will be only observed without prophylaxis
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
112
|
|
Overall Study
COMPLETED
|
203
|
101
|
|
Overall Study
NOT COMPLETED
|
25
|
11
|
Reasons for withdrawal
| Measure |
Ivermectin Group
Contacts who will receive prophylactic ivermectin
Ivermectin Tablets:
40-60 kg (15mg/day) 60-80kg (18mg/day) \>80kg (24mg/day)
|
Control Group
Contacts who will be only observed without prophylaxis
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ivermectin Group
n=203 Participants
Contacts who will receive prophylactic ivermectin
Ivermectin Tablets:
40-60 kg (15mg/day) 60-80kg (18mg/day) \>80kg (24mg/day)
|
Control Group
n=101 Participants
Contacts who will be only observed without prophylaxis
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.75 years
STANDARD_DEVIATION 14.93 • n=203 Participants
|
37.69 years
STANDARD_DEVIATION 16.95 • n=101 Participants
|
38.72 years
STANDARD_DEVIATION 15.94 • n=304 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=203 Participants
|
51 Participants
n=101 Participants
|
148 Participants
n=304 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=203 Participants
|
50 Participants
n=101 Participants
|
156 Participants
n=304 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: within 14 days after enrollementhistory taking and clinical examination
Outcome measures
| Measure |
Ivermectin Group
n=203 Participants
Contacts who will receive prophylactic ivermectin
Ivermectin Tablets:
40-60 kg (15mg/day) 60-80kg (18mg/day) \>80kg (24mg/day)
|
Control Group
n=101 Participants
Contacts who will be only observed without prophylaxis
|
|---|---|---|
|
Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
|
15 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: within 14 days after enrollementby swab
Outcome measures
Outcome data not reported
Adverse Events
Ivermectin Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ivermectin Group
n=203 participants at risk
Contacts who will receive prophylactic ivermectin
Ivermectin Tablets:
40-60 kg (15mg/day) 60-80kg (18mg/day) \>80kg (24mg/day)
|
Control Group
n=101 participants at risk
Contacts who will be only observed without prophylaxis
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.99%
2/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
Gastrointestinal disorders
diarrhea
|
1.5%
3/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
Gastrointestinal disorders
burning sensation
|
0.49%
1/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
Nervous system disorders
tingling/numbness
|
0.49%
1/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
Gastrointestinal disorders
heart burn
|
0.49%
1/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
Gastrointestinal disorders
abdominal pain
|
0.49%
1/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
Nervous system disorders
sleepiness
|
0.49%
1/203 • 14 days
|
0.00%
0/101 • 14 days
|
|
General disorders
fatigue
|
0.99%
2/203 • 14 days
|
0.00%
0/101 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place