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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Ivermectin (IVM)+ Hydroxychloroquin (HCQ)+ Azithromycin (AZT)
Arm/Group Description	Ivermectin 12 mg /weekly )+ Hydroxy...
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 admisi...
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
Baseline Analysis Population Description		[Not Specified]
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
Iraq		16
Severity of CoVID-19 Symptoms ^[1] Measure Type: Count of Participants Unit of measure: Participants
Mild	Number Analyzed	16 participants
Mild		9 56.3%
moderate	Number Analyzed	16 participants
moderate		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
Cough		13 81.3%
Fever	Number Analyzed	16 participants
Fever		11 68.8%
Shortness of breath	Number Analyzed	16 participants
Shortness of breath		9 56.3%
Myalgia	Number Analyzed	16 participants
Myalgia		8 50.0%
Sore throat	Number Analyzed	16 participants
Sore throat		4 25.0%
Comorbidity ( underlying diseases) Measure Type: Number Unit of measure: Participants
Diabetes melitus	Number Analyzed	16 participants
Diabetes melitus		3
Hypertension	Number Analyzed	16 participants
Hypertension		3
Asthma	Number Analyzed	16 participants
Asthma		1

Outcome Measures

1.Primary Outcome


Title	Number of Cured Patients
Description	Primary outcome is assessed by calculating the number of patients who ...
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 a...
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
Description	Time to cure is evaluated by measuring time from admission of the pati...
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 a...
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)

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.

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	IVM+HCQ+AZT Group
Arm/Group Description	Assessment of any adverse events in...
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%)
Serious Adverse Events Serious Adverse Events
	IVM+HCQ+AZT Group
	Affected / at Risk (%)
Total	0/16 (0.00%)
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%)

Limitations and Caveats

small sample size; single center design, and short time for the study

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

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

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