Growth Hormone in Obese Cases With Covid-19 | NCT04532554

Studies
Growth Hormone in Obese Cases With Covid-19

NCT04532554

Sponsor

ClinAmygate

Status

Withdrawn

Last Update Posted

Sep 16, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Covid19

Interventions

Growth Hormone
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Oct 26, 2020Estimated

Primary Completion Date

Dec 10, 2020Estimated

Completion Date

Dec 20, 2020Estimated

First Submitted Date

Aug 24, 2020

First Submission Date that Met QC Criteria

Aug 28, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2020

Last Update Posted Date

Sep 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Growth hormone	Experimental	Recombinant GH will be used for those patients	Drug: Growth Hormone
Placebo	Placebo Comparator	Saline will be used	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Growth Hormone	Drug	Recombinant growth hormone will be used	Growth hormone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to recovery	Time to recovery from symptoms and signs	one to four weeks
Percentage of reduction in CRP	Percentage of reduction in CRP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obese with BMI > 30

Exclusion Criteria:

History of hypersensitivity to GH

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emad R Issak, MD	Assalam Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asalam		Maadi	Cairo Governorate	11433	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16444180	Result	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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D013006	Growth Hormone
D012965	Sodium Chloride

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones