Ivermectin in Treatment of COVID-19

• Sponsor: Zagazig University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04445311
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.5
• Patients Per Site Per Month: 40

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Jul 30, 2020
• Anticipated Study Completion Date: Aug 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. time to be symptoms free [within 21 days after enrollment]

   duration from day 1 symptoms till 3 days without symptoms

Secondary Outcome Measures

1. hospitalization [within 21 days after enrollement]

   need hospital admission

2. Mechanical ventilation [within 21 days after enrollement]

   need mechanical ventilation

3. length of stay [within one month days after enrollement]

   days spent in hospital

4. mortality [within one month days after enrollement]

   survived or died

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Waheed Shouman	Zagazig	Sharkia	Egypt	44519

Sponsors and Collaborators

• Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 24, 2020
• Last Update Posted: Jun 24, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ivermectin

Study Results

No Results Posted as of Jun 24, 2020