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Prophylactic Ivermectin in COVID-19 Contacts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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Brief Summary:
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms & diagnosis of COVID -19

Condition or disease Intervention/treatment Phase
COVID Drug: Ivermectin Tablets Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19
Actual Study Start Date : May 31, 2020
Actual Primary Completion Date : July 14, 2020
Actual Study Completion Date : July 27, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ivermectin group
Contacts who will receive prophylactic ivermectin
 Drug: Ivermectin Tablets
two doses 72 hours apart
No Intervention: Control group
Contacts who will be only observed without prophylaxis


Outcome Measures
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Primary Outcome Measures :
  1. Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) [ Time Frame: within 14 days after enrollement ]
    history taking and clinical examination


Secondary Outcome Measures :
  1. Development of COVID [ Time Frame: within 14 days after enrollement ]
    by swab


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

family contact of confirmed COVID-19 case

Exclusion Criteria:

  • refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422561


Locations
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Egypt
Zagazig University
Zagazig, Sharkia, Egypt, 44519
Sponsors and Collaborators
Zagazig University
  Study Documents (Full-Text)

Documents provided by Waheed Shouman, Zagazig University:
Study Protocol and Statistical Analysis Plan  [PDF] May 31, 2020

More Information
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Responsible Party: Waheed Shouman, professor of chest diseases, Zagazig University
ClinicalTrials.gov Identifier: NCT04422561    
Other Study ID Numbers: ZU-IRB#6150/31-5-2020
First Posted: June 9, 2020    Key Record Dates
Results First Posted: August 27, 2020
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents