Ivermectin in Treatment of COVID-19

June 19, 2020 updated by: Waheed Shouman, Zagazig University

Use of Ivermectin as a Therapeutic Option for Patients With COVID-19

confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Recruiting
        • Waheed Shouman
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

COVID-19 patients during period of the study more than 18 years old

Exclusion Criteria:

refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivermectin group
group that will receive ivermectin plus standard of care ttt
Drug: Ivermectin
3 successive days ttt of ivermectin started within 48 hours of symptoms
No Intervention: Control group
group that will receive standard of care ttt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to be symptoms free
Time Frame: within 21 days after enrollment
duration from day 1 symptoms till 3 days without symptoms
within 21 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization
Time Frame: within 21 days after enrollement
need hospital admission
within 21 days after enrollement
Mechanical ventilation
Time Frame: within 21 days after enrollement
need mechanical ventilation
within 21 days after enrollement
length of stay
Time Frame: within one month days after enrollement
days spent in hospital
within one month days after enrollement
mortality
Time Frame: within one month days after enrollement
survived or died
within one month 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 (Anticipated)

July 30, 2020

Study Completion (Anticipated)

August 15, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#6151/31-5-2020

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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