Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy

NCT03554265 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 17-0313
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.

Conditions

Traumatic Brain Injury; Fatigue; Cognitive Impairment; COVID-19

Keywords

growth hormone; Traumatic Brain injury; concussion; mTBI; fatigue; cognitive impairment; BIAFAC; COVID-19; post-COVID syndrome; long hauler COVID-19; post-acute sequelae of SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

• Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline

  Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.

  baseline

• Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months

  Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.

  6 months

• Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline

  Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.

  baseline

• Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months

  Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.

  6 months

Secondary Outcomes (2)

• Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline

  baseline

• Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months

  6 months

Other Outcomes (36)

• Cognitive Function as Measured by Montreal Cognitive Assessment at Baseline

  baseline

• Cognitive Function as Measured by Montreal Cognitive Assessment at 6 Months

  6 months

• Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at Baseline

  baseline

Study Arms (3)

mTBI subjects

EXPERIMENTAL

mTBI subjects will receive recombinant human growth hormone replacement therapy daily for 6 months. Drug: recombinant human growth hormone (rhgH); somatropin, Genotropin Dose: month 0 - month 1 will be dosed at 0.4 mg / day month 1 - month 6 will be dosed at 0.6 mg / day

Drug: Somatropin

Household Control Subjects

NO INTERVENTION

household control subjects will not receive any intervention.

PASC subjects

EXPERIMENTAL

PASC subjects will receive recombinant human growth hormone replacement therapy daily for 9 months. Drug: recombinant human growth hormone (rhgH); somatropin, Genotropin Dose: month 0 - month 1 will be dosed at 0.4 mg / day month 1 - month 9 will be dosed at 0.6 mg / day

Drug: Somatropin

Interventions

Somatropin DRUG

Genotropin given by injection

Also known as: Genotropin

PASC subjects; mTBI subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with a diagnosis of mild TBI.
• At least 6-month post-injury.
• Ages 18 to 70 years.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

• Unable to walk unassisted.
• Significant heart, liver, kidney, blood or respiratory disease.
• History of chest pain or coronary heart disease.
• Uncontrolled Diabetes mellitus.
• Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
• Recent (within 6 months) treatment with anabolic steroids or corticosteroids.
• Current alcohol or drug abuse.
• Premorbid history of psychiatric disorder.
• Premorbid history of head trauma.
• Pregnancy or become pregnant during the trial.
• Coumadin because of the risk of bleeding with daily injections of rhGH.
• Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
• Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
• Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
• Ages 18 to 70 years.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Wright TJ, Sheffield-Moore M, Pyles RB, Randolph KM, McGovern KA, Danesi CP, Lindsay SE, Zaidan MF, Masel BE, Urban RJ. Growth hormone treatment for neurologic symptoms of post-acute sequelae of COVID-19. Clin Transl Sci. 2024 Jun;17(6):e13826. doi: 10.1111/cts.13826.

  PMID: 38894576 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Fatigue; Cognitive Dysfunction; COVID-19; Brain Concussion

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Randall Urban, MD
• Organization: University of Texas Medical Branch

rurban@utmb.edu

409-772-5476

Study Officials

• Randall J Urban, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mTBI patients will be in the growth hormone arm PASC patients will be in the growth hormone arm Control subjects will be in the control arm

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: June 13, 2018
• Study Start: August 6, 2018
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)