Growth Hormone in Obese Cases With Covid-19

September 15, 2020 updated by: ClinAmygate

The Impact of Growth Hormone in Obese Cases With Covid-19

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Maadi, Cairo, Egypt, 11433
        • Asalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese with BMI > 30

Exclusion Criteria:

  • History of hypersensitivity to GH

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Growth hormone
Recombinant GH will be used for those patients
Drug: Growth Hormone
Recombinant growth hormone will be used
Other Names:
  • Recombinant growth hormone
PLACEBO_COMPARATOR: Placebo
Saline will be used
Drug: Placebo
Saline injection with the same amount
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for hospitalization
Time Frame: one to two weeks
need to be hospitalized due to deterioration
one to two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: one to four weeks
Time to recovery from symptoms and signs
one to four weeks
Percentage of reduction in CRP
Time Frame: one to two weeks
Percentage of reduction in CRP
one to two weeks
Percentage of reduction in LDH
Time Frame: one to two weeks
Percentage of reduction in LDH
one to two weeks
Percentage of reduction in Ferritin
Time Frame: one to two weeks
Percentage of reduction in Ferritin
one to two weeks
Time to recovery from leucopenia
Time Frame: one to two weeks
Time to recovery from leucopenia
one to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ClinAmygate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 26, 2020

Primary Completion (ANTICIPATED)

December 10, 2020

Study Completion (ANTICIPATED)

December 20, 2020

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (ACTUAL)

August 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR0015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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