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Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management

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ClinicalTrials.gov Identifier: NCT04343092
Recruitment Status : Completed
First Posted : April 13, 2020
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Faiq Gorial, University of Baghdad

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COVID 19
Intervention Drug: Ivermectin (IVM)
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Hide 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
Arm/Group Title Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Hide 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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
44.87  (10.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
5
  31.3%
Male
11
  68.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iraq Number Analyzed 16 participants
16
Severity of CoVID-19 Symptoms   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Mild Number Analyzed 16 participants
9
  56.3%
moderate Number Analyzed 16 participants
7
  43.8%
[1]
Measure Description: Severity of COVID-19 were measured according to WHO criteria for grading COVID-19
Clinical features  
Measure Type: Count of Participants
Unit of measure:  Participants
Cough Number Analyzed 16 participants
13
  81.3%
Fever Number Analyzed 16 participants
11
  68.8%
Shortness of breath Number Analyzed 16 participants
9
  56.3%
Myalgia Number Analyzed 16 participants
8
  50.0%
Sore throat Number Analyzed 16 participants
4
  25.0%
Comorbidity ( underlying diseases)  
Measure Type: Number
Unit of measure:  Participants
Diabetes melitus Number Analyzed 16 participants
3
Hypertension Number Analyzed 16 participants
3
Asthma Number Analyzed 16 participants
1
1.Primary Outcome
Title Number of Cured Patients
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVM+HCQ+AZT Group
Hide 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.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
2.Secondary Outcome
Title Time to Cure of COVID-19 Patients in the IVM +HCQ+AZT Group
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVM+HCQ+AZT Group
Hide 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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Days
7.62  (2.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IVM+HCQ+AZT Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.92
Estimation Comments [Not Specified]
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.
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVM+HCQ+AZT Group
Hide 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 (%)
Total   0/16 (0.00%) 
Hide Serious Adverse Events
IVM+HCQ+AZT Group
Affected / at Risk (%)
Total   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVM+HCQ+AZT Group
Affected / at Risk (%)
Total   0/16 (0.00%) 
small sample size; single center design, and short time for the study
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
Layout table for Results Point of Contact information
Name/Title: Faiq I. Gorial
Organization: College of Medicine-University of Baghdad
Phone: 009647801730696
EMail: faiqig@gmail.com
Layout table for additonal information
Responsible Party: Faiq Gorial, University of Baghdad
ClinicalTrials.gov Identifier: NCT04343092    
Other Study ID Numbers: PRO20040001
First Submitted: April 5, 2020
First Posted: April 13, 2020
Results First Submitted: June 11, 2020
Results First Posted: November 4, 2020
Last Update Posted: November 4, 2020