NCT04532554

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

August 24, 2020

Last Update Submit

September 15, 2020

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Need for hospitalization

    need to be hospitalized due to deterioration

    one to two weeks

Secondary Outcomes (5)

  • Time to recovery

    one to four weeks

  • Percentage of reduction in CRP

    one to two weeks

  • Percentage of reduction in LDH

    one to two weeks

  • Percentage of reduction in Ferritin

    one to two weeks

  • Time to recovery from leucopenia

    one to two weeks

Study Arms (2)

Growth hormone

EXPERIMENTAL

Recombinant GH will be used for those patients

Drug: Growth Hormone

Placebo

PLACEBO COMPARATOR

Saline will be used

Drug: Placebo

Interventions

Growth HormoneDRUG

Recombinant growth hormone will be used

Also known as: Recombinant growth hormone
Growth hormone
PlaceboDRUG

Saline injection with the same amount

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese with BMI \> 30

You may not qualify if:

  • History of hypersensitivity to GH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asalam

Maadi, Cairo Governorate, 11433, Egypt

Location

Related 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.

    PMID: 16444180RESULT

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Growth HormoneSodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Emad R Issak, MD

    Assalam Clinics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 31, 2020

Study Start

October 26, 2020

Primary Completion

December 10, 2020

Study Completion

December 20, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)