Back to resultsEffect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ivermectin + colchicine
Colchicine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide written informed consent prior to performing study procedures.
- Currently hospitalized and requiring medical care for non-sever COVID-19.
- One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection).
Exclusion Criteria:
- Tocilizumab use.
- Mechanical ventilation
- Requirement of oxygen supplementation >8L/min on admission
Sites / Locations
- Ain Shams University hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Ivermectin + colchicine + standard care
Colchicine + standard care
standard care
Arm Description
In addition to the local standard of care for COVID 19 patients, the patient will receive: Ivermectin + Colchicine
In addition to the local standard of care for COVID 19 patients, the patient will receive: Colchicine
Patients will receive Standard care
Outcomes
Primary Outcome Measures
length of oxygen requirement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05246072
Brief Title
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
Official Title
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ivermectin + colchicine + standard care
Arm Type
Active Comparator
Arm Description
In addition to the local standard of care for COVID 19 patients, the patient will receive:
Ivermectin + Colchicine
Arm Title
Colchicine + standard care
Arm Type
Active Comparator
Arm Description
In addition to the local standard of care for COVID 19 patients, the patient will receive:
Colchicine
Arm Title
standard care
Arm Type
No Intervention
Arm Description
Patients will receive Standard care
Intervention Type
Drug
Intervention Name(s)
Ivermectin + colchicine
Intervention Description
In addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine
Primary Outcome Measure Information:
Title
length of oxygen requirement
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide written informed consent prior to performing study procedures.
Currently hospitalized and requiring medical care for non-sever COVID-19.
One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection).
Exclusion Criteria:
Tocilizumab use.
Mechanical ventilation
Requirement of oxygen supplementation >8L/min on admission
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
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