Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)
Comparing effectiveness of single dose 0.2mg/kg Ivermectin (IVM) plus hydroxychloroquine (HCQ) 400mg BID in first day then 200mg BID for 5 days plus azithromycin (AZT) 500mg in first day then 250mg for 5 days.
The comparison group was a historical control population and data collected from the current study were compared to that historical control population
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) | Experimental | Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin (IVM) | Drug | Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cured Patients | Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group | Time to cure is evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed | 4 week |
Not provided
Inclusion Criteria:
-1. Patients with age above 18 years and any gender with definite Dx of covid19 and pneumonia in the ward according to the clinical, laboratory, and imaging criteria.
2. Understands and agrees to comply with planned study procedures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Faiq I Gorial, Professor | University of Baghdad | Principal Investigator |
| Jawad I. Rasheed | Arab Board for Health Specialiazation in Iraq | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Directorate of Medical City | Baghdad | Baghdad Governorate | 964 | Iraq |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) | Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily Ivermectin (IVM): Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) | IVM 0.2mg /kg single dose at admisison day HCQ 400mg BID in the first day then 200mg BID for 5 days AZT 500mg in the first day then 250mg for 5 days |
| 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 | Number of Cured Patients | Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab. | Posted | Count of Participants | Participants | 4 weeks |
|
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVM+HCQ+AZT Group | Assessment of any adverse events in 0.2mg IVM single dose on admission day +HCQ 400mg BID in the first day then 200mg BID for 5 days+AZT 500mg in the first day then 250mg for 5 days |
Not provided
Not provided
small sample size; single center design, and short time for the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Faiq I. Gorial | College of Medicine-University of Baghdad | 009647801730696 | faiqig@gmail.com |
Not provided
| 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 | Jul 15, 2020 | Nov 2, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Severity of CoVID-19 Symptoms | Severity of COVID-19 were measured according to WHO criteria for grading COVID-19 | Count of Participants | Participants |
|
| Clinical features | Count of Participants | Participants |
|
| Comorbidity ( underlying diseases) | Number | participants |
|
|
|
| Secondary | Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group | Time to cure is evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed | Posted | Mean | Standard Deviation | Days | 4 week |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |