COVID 19
Conditions
Brief summary
Comparing the effectiveness of Ivermectin( IVM) +Hydroxychloroquin + azithromycin (AZT) group to Hydroxychloroquin (HCQ) + azithromycin (AZT)
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
Interventions
DRUGIvermectin (IVM)
Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
Sponsors
University of Baghdad
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Patients with hypersensitivity or severe adverse effects to Ivermectin 2. Renal impairment 3. Hepatic impairment. 4. Pregnancy or a desire to become pregnant (drug considered pregnancy category c) 5. Breast feeding. 6. Patient with covid 19 positive and mild no pneumonia 7. Children under the age of five or those who weigh less than 15 kilograms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iraq
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT) | — |
|---|---|---|
| Age, Continuous | 44.87 years STANDARD_DEVIATION 10.64 | — |
| Clinical features Cough | 13 Participants | — |
| Clinical features Fever | 11 Participants | — |
| Clinical features Myalgia | 8 Participants | — |
| Clinical features Shortness of breath | 9 Participants | — |
| Clinical features Sore throat | 4 Participants | — |
| Comorbidity ( underlying diseases) Asthma | 1 participants | — |
| Comorbidity ( underlying diseases) Diabetes melitus | 3 participants | — |
| Comorbidity ( underlying diseases) Hypertension | 3 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Iraq | 16 participants | — |
| Severity of CoVID-19 Symptoms Mild | 9 Participants | — |
| Severity of CoVID-19 Symptoms moderate | 7 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IVM+HCQ+AZT Group | Number of Cured Patients | 16 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
Time frame: 4 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IVM+HCQ+AZT Group | Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group | 7.62 Days | Standard Deviation 2.75 |
p-value: 0.05t-test, 2 sided