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Ivermectin as a Novel Therapy in COVID-19 Treatment

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: NCT04403555
Recruitment Status : Completed
First Posted : May 27, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Efficacy of Ivermectin in COVID-19 treatment

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

Detailed Description:
Clinical Study Evaluating the Efficacy of Ivermectin in COVID-19 treatment
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Ivermectin in COVID-19 Treatment
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : December 1, 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
Ivermectin plus standard of care treatment Dose 2 tablets 12mg per day for 3 days
 Drug: Ivermectin
Ivermectin treatment
Other Name: iverzine, ivermectin
No Intervention: Standard of care
Standard of care treatment


Outcome Measures
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Primary Outcome Measures :
  1. The number of patients with mortality [ Time Frame: 1 month ]
    Improvement of survival


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 1 month ]
    Effect on the length of hospital stay

  2. The need for mechanical ventilation [ Time Frame: 1 month ]
    Need for mechanical ventilation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR.

Exclusion Criteria:

  • Allergy or contraindication to the drugs used in the study.
  • Pregnant and lactating mothers.
  • Patients with cardiac problems.
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): NCT04403555


Locations
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Egypt
Sherief Abd-Elsalam
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: sherief Abd-Elsalam, Ass. Prof. ass. Prof. Tropical Medicine
More Information
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04403555    
Other Study ID Numbers: tanta covid treatment
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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