Back to resultsGrowth Hormone in Obese Cases With Covid-19
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Growth Hormone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Obese with BMI > 30
Exclusion Criteria:
- History of hypersensitivity to GH
Sites / Locations
- Asalam
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Growth hormone
Placebo
Arm Description
Recombinant GH will be used for those patients
Saline will be used
Outcomes
Primary Outcome Measures
Need for hospitalization
need to be hospitalized due to deterioration
Secondary Outcome Measures
Time to recovery
Time to recovery from symptoms and signs
Percentage of reduction in CRP
Percentage of reduction in CRP
Percentage of reduction in LDH
Percentage of reduction in LDH
Percentage of reduction in Ferritin
Percentage of reduction in Ferritin
Time to recovery from leucopenia
Time to recovery from leucopenia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04532554
Brief Title
Growth Hormone in Obese Cases With Covid-19
Official Title
The Impact of Growth Hormone in Obese Cases With Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
October 26, 2020 (Anticipated)
Primary Completion Date
December 10, 2020 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.
Detailed Description
It is well known that lymphoid organs such the thymus, the spleen and peripheral blood produce growth hormone (GH) and GH receptor is expressed on different subpopulations of lymphocytes. Many in vitro and in animal studies demonstrate an important role of GH in immunoregulation. GH stimulates T and B cells proliferation and immunoglobulin synthesis, enhances the maturation of myeloid progenitor cells and is also able to modulate cytokine response.
The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.
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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Growth hormone
Arm Type
Experimental
Arm Description
Recombinant GH will be used for those patients
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline will be used
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
Recombinant growth hormone
Intervention Description
Recombinant growth hormone will be used
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Saline injection with the same amount
Primary Outcome Measure Information:
Title
Need for hospitalization
Description
need to be hospitalized due to deterioration
Time Frame
one to two weeks
Secondary Outcome Measure Information:
Title
Time to recovery
Description
Time to recovery from symptoms and signs
Time Frame
one to four weeks
Title
Percentage of reduction in CRP
Description
Percentage of reduction in CRP
Time Frame
one to two weeks
Title
Percentage of reduction in LDH
Description
Percentage of reduction in LDH
Time Frame
one to two weeks
Title
Percentage of reduction in Ferritin
Description
Percentage of reduction in Ferritin
Time Frame
one to two weeks
Title
Time to recovery from leucopenia
Description
Time to recovery from leucopenia
Time Frame
one to two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obese with BMI > 30
Exclusion Criteria:
History of hypersensitivity to GH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad R Issak, MD
Organizational Affiliation
Assalam Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asalam
City
Maadi
State/Province
Cairo
ZIP/Postal Code
11433
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16444180
Citation
Meazza C, Pagani S, Travaglino P, Bozzola M. Effect of growth hormone (GH) on the immune system. Pediatr Endocrinol Rev. 2004 Aug;1 Suppl 3:490-5.
Results Reference
result
Learn more about this trial
Growth Hormone in Obese Cases With Covid-19
We'll reach out to this number within 24 hrs