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Ivermectin in Treatment of COVID-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445311
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Waheed Shouman, Zagazig University

Brief Summary:
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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Ivermectin as a Therapeutic Option for Patients With COVID-19
Actual Study Start Date : May 31, 2020
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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



Primary Outcome Measures :
  1. time to be symptoms free [ Time Frame: within 21 days after enrollment ]
    duration from day 1 symptoms till 3 days without symptoms


Secondary Outcome Measures :
  1. hospitalization [ Time Frame: within 21 days after enrollement ]
    need hospital admission

  2. Mechanical ventilation [ Time Frame: within 21 days after enrollement ]
    need mechanical ventilation

  3. length of stay [ Time Frame: within one month days after enrollement ]
    days spent in hospital

  4. mortality [ Time Frame: within one month days after enrollement ]
    survived or died



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT04445311


Contacts
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Contact: Waheed Shouman, MD +201114812048 shouman66@gmail.com

Locations
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Egypt
Waheed Shouman Recruiting
Zagazig, Sharkia, Egypt, 44519
Contact: Waheed Shouman, MD    +201114812048    shouman66@gmail.com   
Sponsors and Collaborators
Zagazig University
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Responsible Party: Waheed Shouman, professor of chest diseases, Zagazig University
ClinicalTrials.gov Identifier: NCT04445311    
Other Study ID Numbers: ZU-IRB#6151/31-5-2020
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 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