Prophylactic Ivermectin in COVID-19 Contacts

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ClinicalTrials.gov Identifier: NCT04422561

Recruitment Status : Completed

First Posted : June 9, 2020

Results First Posted : August 27, 2020

Last Update Posted : August 27, 2020

Sponsor:

Information provided by (Responsible Party):

Waheed Shouman, Zagazig University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition	COVID
Intervention	Drug: Ivermectin Tablets
Enrollment	340

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Ivermectin Group	Control Group
Arm/Group Description	Contacts who will receive prophylac...	Contacts who will be only observed ...
Arm/Group Description	Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)	Contacts who will be only observed without prophylaxis
Period Title: Overall Study
Started	228	112
Completed	203	101
Not Completed	25	11
Reason Not Completed
Lost to Follow-up	25	11

Baseline Characteristics

Arm/Group Title		Ivermectin Group	Control Group	Total
Arm/Group Description		Contacts who will receive prophylac...	Contacts who will be only observed ...	Total of all reporting groups
Arm/Group Description		Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)	Contacts who will be only observed without prophylaxis	Total of all reporting groups
Overall Number of Baseline Participants		203	101	304
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	203 participants	101 participants	304 participants
		39.75 (14.93)	37.69 (16.95)	38.72 (15.94)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	203 participants	101 participants	304 participants
	Female	97 47.8%	51 50.5%	148 48.7%
	Male	106 52.2%	50 49.5%	156 51.3%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Outcome Measures

1.Primary Outcome


Title	Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
Description	history taking and clinical examination
Description	history taking and clinical examination
Time Frame	within 14 days after enrollement

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Ivermectin Group	Control Group
Arm/Group Description:	Contacts who will receive prophylac...	Contacts who will be only observed ...
Arm/Group Description:	Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)	Contacts who will be only observed without prophylaxis
Overall Number of Participants Analyzed	203	101
Measure Type: Count of Participants Unit of Measure: Participants
	15 7.4%	59 58.4%

2.Secondary Outcome


Title	Development of COVID
Description	by swab
Description	by swab
Time Frame	within 14 days after enrollement

Outcome Measure Data Not Reported

Adverse Events

Time Frame	14 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Ivermectin Group	Control Group
Arm/Group Description	Contacts who will receive prophylac...	Contacts who will be only observed ...
Arm/Group Description	Contacts who will receive prophylactic ivermectin Ivermectin Tablets: 40-60 kg (15mg/day) 60-80kg (18mg/day) >80kg (24mg/day)	Contacts who will be only observed without prophylaxis
All-Cause Mortality
	Ivermectin Group	Control Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/203 (0.00%)	0/101 (0.00%)
Serious Adverse Events Serious Adverse Events
	Ivermectin Group	Control Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/203 (0.00%)	0/101 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Ivermectin Group	Control Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	11/203 (5.42%)	0/101 (0.00%)
Gastrointestinal disorders
nausea ^*	2/203 (0.99%)	0/101 (0.00%)
diarrhea ^*	3/203 (1.48%)	0/101 (0.00%)
burning sensation ^*	1/203 (0.49%)	0/101 (0.00%)
heart burn ^*	1/203 (0.49%)	0/101 (0.00%)
abdominal pain ^*	1/203 (0.49%)	0/101 (0.00%)
General disorders
fatigue ^*	2/203 (0.99%)	0/101 (0.00%)
Nervous system disorders
tingling/numbness ^*	1/203 (0.49%)	0/101 (0.00%)
sleepiness ^*	1/203 (0.49%)	0/101 (0.00%)
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Waheed Shouman
Organization:	Zagazig University
Phone:	+201114812048
EMail:	shouman66@gmail.com

Layout table for additonal information

Responsible Party:	Waheed Shouman, Zagazig University
ClinicalTrials.gov Identifier:	NCT04422561
Other Study ID Numbers:	ZU-IRB#6150/31-5-2020
First Submitted:	June 6, 2020
First Posted:	June 9, 2020
Results First Submitted:	August 23, 2020
Results First Posted:	August 27, 2020
Last Update Posted:	August 27, 2020

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