Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 6, 2020
First Posted Date  ICMJE June 9, 2020
Results First Submitted Date  ICMJE August 23, 2020
Results First Posted Date  ICMJE August 27, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE May 31, 2020
Actual Primary Completion Date July 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2020)
Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) [ Time Frame: within 14 days after enrollement ]
history taking and clinical examination
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2020)
appearance of symptoms ( fever ,cough, sore throat, myalgia,diarrhea, shortness of breath) [ Time Frame: within 14 days after enrollement ]
history taking
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2020)
Development of COVID [ Time Frame: within 14 days after enrollement ]
by swab
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2020)
development of COVID [ Time Frame: within 14 days after enrollement ]
by swab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Ivermectin in COVID-19 Contacts
Official Title  ICMJE Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID
Intervention  ICMJE Drug: Ivermectin Tablets
two doses 72 hours apart
Study Arms  ICMJE
  • Experimental: Ivermectin group
    Contacts who will receive prophylactic ivermectin
    Intervention: Drug: Ivermectin Tablets
  • No Intervention: Control group
    Contacts who will be only observed without prophylaxis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2020)
340
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2020)
100
Actual Study Completion Date  ICMJE July 27, 2020
Actual Primary Completion Date July 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04422561
Other Study ID Numbers  ICMJE ZU-IRB#6150/31-5-2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Waheed Shouman, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zagazig University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP