COVID
Conditions
Brief summary
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms & diagnosis of COVID -19
Interventions
two doses 72 hours apart
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
family contact of confirmed COVID-19 case
Exclusion criteria
* refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) | within 14 days after enrollement | history taking and clinical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of COVID | within 14 days after enrollement | by swab |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ivermectin Group Contacts who will receive prophylactic ivermectin
Ivermectin Tablets:
40-60 kg (15mg/day) 60-80kg (18mg/day) \>80kg (24mg/day) | 203 |
| Control Group Contacts who will be only observed without prophylaxis | 101 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 25 | 11 |
Baseline characteristics
| Characteristic | Ivermectin Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 39.75 years STANDARD_DEVIATION 14.93 | 37.69 years STANDARD_DEVIATION 16.95 | 38.72 years STANDARD_DEVIATION 15.94 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 97 Participants | 51 Participants | 148 Participants |
| Sex: Female, Male Male | 106 Participants | 50 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 101 |
| other Total, other adverse events | 11 / 203 | 0 / 101 |
| serious Total, serious adverse events | 0 / 203 | 0 / 101 |
Outcome results
Primary
Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
history taking and clinical examination
Time frame: within 14 days after enrollement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ivermectin Group | Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) | 15 Participants |
| Control Group | Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) | 59 Participants |
Secondary
Development of COVID
by swab
Time frame: within 14 days after enrollement