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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Recruitment Status : Withdrawn (No participants enrolled)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

Study Description
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Brief Summary:
The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Growth Hormone Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Growth Hormone in Obese Cases With Covid-19
Estimated Study Start Date : October 26, 2020
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Growth hormone
Recombinant GH will be used for those patients
 Drug: Growth Hormone
Recombinant growth hormone will be used
Other Name: Recombinant growth hormone
Placebo Comparator: Placebo
Saline will be used
 Drug: Placebo
Saline injection with the same amount
Other Name: Saline


Outcome Measures
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Primary Outcome Measures :
  1. Need for hospitalization [ Time Frame: one to two weeks ]
    need to be hospitalized due to deterioration


Secondary Outcome Measures :
  1. Time to recovery [ Time Frame: one to four weeks ]
    Time to recovery from symptoms and signs

  2. Percentage of reduction in CRP [ Time Frame: one to two weeks ]
    Percentage of reduction in CRP

  3. Percentage of reduction in LDH [ Time Frame: one to two weeks ]
    Percentage of reduction in LDH

  4. Percentage of reduction in Ferritin [ Time Frame: one to two weeks ]
    Percentage of reduction in Ferritin

  5. Time to recovery from leucopenia [ Time Frame: one to two weeks ]
    Time to recovery from leucopenia


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese with BMI > 30

Exclusion Criteria:

  • History of hypersensitivity to GH
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532554


Locations
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Egypt
Asalam
Maadi, Cairo, Egypt, 11433
Sponsors and Collaborators
ClinAmygate
Investigators
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Principal Investigator: Emad R Issak, MD Assalam Clinics
More Information
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Publications of Results:

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Responsible Party: ClinAmygate
ClinicalTrials.gov Identifier: NCT04532554    
Other Study ID Numbers: PR0015
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs