Back to resultsIvermectin In Treatment of COVID 19 Patients
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ivermectin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap
Exclusion Criteria:
- Contraindications for the drug: hypersensitivity.
- Any medications with possible drug interactions.
- Severe cases.
- Any malignant condition.
- Pregnant females.
- Breast feeding females.
- Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.
Sites / Locations
- isolation and referal hospitals for COVID 19 patientsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
A ivermectin alone
B standard care alone
C ivermectin added to standard of care
Arm Description
ivermectin will be administarted alone to COVID 19 patients
standard care will be administarted alone
ivermectin will be administarted in adition to standard care
Outcomes
Primary Outcome Measures
to evaluate the role of Ivermectin as a line of treatment for COVID 19
the role of ivermectin in the cure of COVID 19 patients
Secondary Outcome Measures
To asses the rate of viral clearance in comparison to other treatment protocols.
to compare the results of ivermectin with the standard care
Full Information
NCT ID
NCT04425707
First Posted
June 8, 2020
Last Updated
June 8, 2020
Sponsor
Ministry of Health and Population, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04425707
Brief Title
Ivermectin In Treatment of COVID 19 Patients
Official Title
The Use of Ivermectin In the Treatment of COVID 19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health and Population, Egypt
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
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
Detailed Description
the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A ivermectin alone
Arm Type
Experimental
Arm Description
ivermectin will be administarted alone to COVID 19 patients
Arm Title
B standard care alone
Arm Type
Experimental
Arm Description
standard care will be administarted alone
Arm Title
C ivermectin added to standard of care
Arm Type
Active Comparator
Arm Description
ivermectin will be administarted in adition to standard care
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
hydroxychloroquine
Intervention Description
use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
Primary Outcome Measure Information:
Title
to evaluate the role of Ivermectin as a line of treatment for COVID 19
Description
the role of ivermectin in the cure of COVID 19 patients
Time Frame
2 months
Secondary Outcome Measure Information:
Title
To asses the rate of viral clearance in comparison to other treatment protocols.
Description
to compare the results of ivermectin with the standard care
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap
Exclusion Criteria:
Contraindications for the drug: hypersensitivity.
Any medications with possible drug interactions.
Severe cases.
Any malignant condition.
Pregnant females.
Breast feeding females.
Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ehab ah kamal, MD
Phone
01006162663
Email
ehabkamal2011@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
noha mo asem, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
houssam ho masoud, MD
Organizational Affiliation
COVID sceintific comittee ministry of health and population
Official's Role
Study Director
Facility Information:
Facility Name
isolation and referal hospitals for COVID 19 patients
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ehab ah kamal, MD
Phone
01006162663
12. IPD Sharing Statement
Learn more about this trial
Ivermectin In Treatment of COVID 19 Patients
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