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Growth Hormone in Obese Cases With Covid-19

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: NCT04532554
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : August 31, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
ClinAmygate

Tracking Information
First Submitted Date  ICMJE August 24, 2020
First Posted Date  ICMJE August 31, 2020
Last Update Posted Date September 16, 2020
Estimated Study Start Date  ICMJE October 26, 2020
Estimated Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2020)		 Need for hospitalization [ Time Frame: one to two weeks ]
need to be hospitalized due to deterioration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • Time to recovery [ Time Frame: one to four weeks ]
    Time to recovery from symptoms and signs
  • Percentage of reduction in CRP [ Time Frame: one to two weeks ]
    Percentage of reduction in CRP
  • Percentage of reduction in LDH [ Time Frame: one to two weeks ]
    Percentage of reduction in LDH
  • Percentage of reduction in Ferritin [ Time Frame: one to two weeks ]
    Percentage of reduction in Ferritin
  • Time to recovery from leucopenia [ Time Frame: one to two weeks ]
    Time to recovery from leucopenia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Growth Hormone in Obese Cases With Covid-19
Official Title  ICMJE The Impact of Growth Hormone in Obese Cases With Covid-19
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Growth Hormone
    Recombinant growth hormone will be used
    Other Name: Recombinant growth hormone
  • Drug: Placebo
    Saline injection with the same amount
    Other Name: Saline
Study Arms  ICMJE
  • Experimental: Growth hormone
    Recombinant GH will be used for those patients
    Intervention: Drug: Growth Hormone
  • Placebo Comparator: Placebo
    Saline will be used
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 15, 2020)		 0
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2020)		 20
Estimated Study Completion Date  ICMJE December 20, 2020
Estimated Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obese with BMI > 30

Exclusion Criteria:

  • History of hypersensitivity to GH
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04532554
Other Study ID Numbers  ICMJE PR0015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ClinAmygate
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ClinAmygate
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emad R Issak, MD Assalam Clinics
PRS Account ClinAmygate
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP