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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin group | Experimental | Contacts who will receive prophylactic ivermectin |
|
| Control group | No Intervention | Contacts who will be only observed without prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Tablets | Drug | two doses 72 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) | history taking and clinical examination | within 14 days after enrollement |
| Measure | Description | Time Frame |
|---|---|---|
| Development of COVID | by swab | within 14 days after enrollement |
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Inclusion Criteria:
family contact of confirmed COVID-19 case
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Zagazig | Sharqia Province | 44519 | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ivermectin Group | Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day) |
| FG001 | Control Group | Contacts who will be only observed without prophylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ivermectin Group | Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day) |
| BG001 | Control Group | Contacts who will be only observed without prophylaxis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) | history taking and clinical examination | Posted | Count of Participants | Participants | within 14 days after enrollement |
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ivermectin Group | Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Waheed Shouman | Zagazig University | +201114812048 | shouman66@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2020 | Aug 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Development of COVID | by swab | Not Posted | within 14 days after enrollement | Participants |
| 0 |
| 203 |
| 0 |
| 203 |
| 11 |
| 203 |
| EG001 | Control Group | Contacts who will be only observed without prophylaxis | 0 | 101 | 0 | 101 | 0 | 101 |
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| burning sensation | Gastrointestinal disorders | Non-systematic Assessment |
|
| tingling/numbness | Nervous system disorders | Non-systematic Assessment |
|
| heart burn | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| sleepiness | Nervous system disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
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