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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04532554
Other study ID # PR0015
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date October 26, 2020
Est. completion date December 20, 2020

Study information

Verified date September 2020
Source ClinAmygate
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 20, 2020
Est. primary completion date December 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Obese with BMI > 30

Exclusion Criteria:

- History of hypersensitivity to GH

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Growth Hormone
Recombinant growth hormone will be used
Placebo
Saline injection with the same amount

Locations

Country Name City State
Egypt Asalam Maadi Cairo

Sponsors (1)

Lead Sponsor Collaborator
ClinAmygate

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Need for hospitalization need to be hospitalized due to deterioration one to two weeks
Secondary Time to recovery Time to recovery from symptoms and signs one to four weeks
Secondary Percentage of reduction in CRP Percentage of reduction in CRP one to two weeks
Secondary Percentage of reduction in LDH Percentage of reduction in LDH one to two weeks
Secondary Percentage of reduction in Ferritin Percentage of reduction in Ferritin one to two weeks
Secondary Time to recovery from leucopenia Time to recovery from leucopenia one to two weeks
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