Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management
Study Details
Study Description
Brief Summary
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) Ivermectin 12 mg /weekly )+ Hydroxychloroquine 400mg/daily + azithromycin 500mg daily |
Drug: Ivermectin (IVM)
Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Cured Patients [4 weeks]
Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
Secondary Outcome Measures
- Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group [4 week]
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
Eligibility Criteria
Criteria
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.
- Understands and agrees to comply with planned study procedures.
Exclusion Criteria:
-
Patients with hypersensitivity or severe adverse effects to Ivermectin
-
Renal impairment
-
Hepatic impairment.
-
Pregnancy or a desire to become pregnant (drug considered pregnancy category c)
-
Breast feeding.
-
Patient with covid 19 positive and mild no pneumonia
-
Children under the age of five or those who weigh less than 15 kilograms
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Directorate of Medical City | Bagdad | Baghdad | Iraq | 964 |
Sponsors and Collaborators
- University of Baghdad
Investigators
- Principal Investigator: Faiq I Gorial, Professor, University of Baghdad
- Study Chair: Jawad I. Rasheed, Arab Board for Health Specialiazation in Iraq
Study Documents (Full-Text)
More Information
Publications
None provided.- PRO20040001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 16 |
| COMPLETED | 16 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 16 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
44.87
(10.64)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
31.3%
|
| Male |
11
68.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| Iraq |
16
100%
|
| Severity of CoVID-19 Symptoms (Count of Participants) | |
| Mild |
9
56.3%
|
| moderate |
7
43.8%
|
| Clinical features (Count of Participants) | |
| Cough |
13
81.3%
|
| Fever |
11
68.8%
|
| Shortness of breath |
9
56.3%
|
| Myalgia |
8
50%
|
| Sore throat |
4
25%
|
| Comorbidity ( underlying diseases) (participants) [Number] | |
| Diabetes melitus |
3
18.8%
|
| Hypertension |
3
18.8%
|
| Asthma |
1
6.3%
|
Outcome Measures
| Title | Number of Cured Patients |
|---|---|
| Description | Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab. |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | IVM+HCQ+AZT Group |
|---|---|
| Arm/Group Description | Time to cure in IVM+HCQ+AZT group and 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. |
| Measure Participants | 16 |
| Count of Participants [Participants] |
16
100%
|
| Title | Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group |
|---|---|
| Description | 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 |
| Time Frame | 4 week |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | IVM+HCQ+AZT Group |
|---|---|
| Arm/Group Description | Time to cure in IVM+HCQ+AZT group and 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. |
| Measure Participants | 16 |
| Mean (Standard Deviation) [Days] |
7.62
(2.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IVM+HCQ+AZT Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.92 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Other Statistical Analysis | Historical control population included: Hydroxychloroquin (HCQ) 400mg BID at admission day then 200mg BID for 5 days plus Azithromycin (AZT) 500mg at admission day then 250mg for 5 days. | |
Adverse Events
| Time Frame | 4 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | IVM+HCQ+AZT Group | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| IVM+HCQ+AZT Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Serious Adverse Events |
||
| IVM+HCQ+AZT Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| IVM+HCQ+AZT Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Faiq I. Gorial |
|---|---|
| Organization | College of Medicine-University of Baghdad |
| Phone | 009647801730696 |
| faiqig@gmail.com |
- PRO20040001