Prophylactic Ivermectin in COVID-19 Contacts

August 23, 2020 updated by: Waheed Shouman, Zagazig University

Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of COVID
Time Frame: within 14 days after enrollement
by swab
within 14 days after enrollement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2020

Primary Completion (ACTUAL)

July 14, 2020

Study Completion (ACTUAL)

July 27, 2020

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 6, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#6150/31-5-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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