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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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ivermectin Group Control Group
Hide 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
Arm/Group Title Ivermectin Group Control Group Total
Hide 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
Hide 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.
1.Primary Outcome
Title Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
Hide Description history taking and clinical examination
Time Frame within 14 days after enrollement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Group Control Group
Hide 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
Hide Description by swab
Time Frame within 14 days after enrollement
Outcome Measure Data Not Reported
Time Frame 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ivermectin Group Control Group
Hide 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%) 
Hide Serious Adverse Events
Ivermectin Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/203 (0.00%)   0/101 (0.00%) 
Hide 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
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