Trial Outcomes & Findings for Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (NCT NCT04343092)
NCT ID: NCT04343092
Last Updated: 2020-11-04
Results Overview
Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
COMPLETED
PHASE1
16 participants
4 weeks
2020-11-04
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
n=16 Participants
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
|
|---|---|
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Age, Continuous
|
44.87 years
STANDARD_DEVIATION 10.64 • n=16 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=16 Participants
|
|
Region of Enrollment
Iraq
|
16 participants
n=16 Participants
|
|
Severity of CoVID-19 Symptoms
Mild
|
9 Participants
n=16 Participants
|
|
Severity of CoVID-19 Symptoms
moderate
|
7 Participants
n=16 Participants
|
|
Clinical features
Cough
|
13 Participants
n=16 Participants
|
|
Clinical features
Fever
|
11 Participants
n=16 Participants
|
|
Clinical features
Shortness of breath
|
9 Participants
n=16 Participants
|
|
Clinical features
Myalgia
|
8 Participants
n=16 Participants
|
|
Clinical features
Sore throat
|
4 Participants
n=16 Participants
|
|
Comorbidity ( underlying diseases)
Diabetes melitus
|
3 participants
n=16 Participants
|
|
Comorbidity ( underlying diseases)
Hypertension
|
3 participants
n=16 Participants
|
|
Comorbidity ( underlying diseases)
Asthma
|
1 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPrimary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.
Outcome measures
| Measure |
IVM+HCQ+AZT Group
n=16 Participants
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.
|
|---|---|
|
Number of Cured Patients
|
16 Participants
|
SECONDARY outcome
Timeframe: 4 weekTime 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
Outcome measures
| Measure |
IVM+HCQ+AZT Group
n=16 Participants
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.
|
|---|---|
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Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group
|
7.62 Days
Standard Deviation 2.75
|
Adverse Events
IVM+HCQ+AZT Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Faiq I. Gorial
College of Medicine-University of Baghdad
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place