Traumatic Brain InjuryPhase 3NCT03554265
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
A Phase 3 study testing Somatropin in people with Traumatic Brain Injury and Fatigue, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Fatigue, Cognitive Impairment
- What is being tested?
- Somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 4 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
mTBI Inclusion criteria
- 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. mTBI Exclusion criteria
- 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.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
Control Inclusion criteria
- Ages 18 to 70 years.
- Participant is willing and able to give informed consent for participation in the study.
Control Exclusion criteria
- Significant heart, liver, kidney, blood or respiratory 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.
- Subjects who are deficient in thyroid at screening will be excluded until thyroid hormone is replaced.
- Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
PASC Inclusion criteria
- Male or female with a history of COVID with diagnosis confirmed by PCR test.
- Minimum of 6 months since diagnosis of COVID by PCR test.
- Ages 18 to 70 years.
- Score of 3 or higher on any question 1-3 of the Brief Fatigue Inventory (BFI) questionnaire.
- Participant is willing and able to give informed consent for participation in the study.
PASC Exclusion criteria
- Current COVID infection.
- Unable to walk unassisted.
- Significant heart, liver, kidney, blood or respiratory disease as determined by Principal Investigator.
- Uncontrolled diabetes mellitus.
- Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
- Current alcohol or drug abuse.
- History of psychosis.
- Pregnancy or become pregnant during the trial.
- Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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.
Read the detailed description
The investigators will study subjects (aged 18-70 years) with a history of mild TBI (n=25), post-acute sequelae of SARS-CoV-2 (PASC) (n=25)and healthy controls (n=25). mTBI subjects will undergo a 6-month intervention of rhGH therapy. PASC subjects will undergo a 9-month intervention of rhGH therapy. Controls will be asked to participate in questionnaires, blood draws (amino acid analysis), and fecal sampling (GI microbiome analysis). Controls will not receive any growth hormone treatment.
mTBI group
All patients presenting with a prior mTBI will undergo a phone pre-screen including the Brief Fatigue Inventory (BFI) questions 1-3. If they score ≥ 3 on any BFI questions 1-3, and are interested in participating in the study, they will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC). During the medical screening, eligibility will be confirmed and a glucagon stimulation test (GST) will be performed. A glucagon stimulation with a growth hormone peak of <10 ng/mL is required to qualify for enrollment.
PASC group
All patients presenting with PASC will undergo a phone pre-screen including the Brief Fatigue Inventory (BFI) questions 1-3. If they score ≥ 3 on any BFI questions 1-3, and are interested in participating in the study, they will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC). During the medical screening, eligibility will be confirmed and a glucagon stimulation test (GST) will be performed. A glucagon stimulation with a growth hormone peak of <10 ng/mL is required to qualify for enrollment.
Control group
All controls will undergo a phone pre-screen and if interested in participating in the study, will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC).
Experimental Protocol.
mTBI Group
Before and at completion (month 6) of the rhGH intervention, mTBI subjects will report to the UTMB Institute for Translational Sciences (ITS) Clinical Research Center (CRC) for testing, which will consist of cognitive function assessment (MoCA), determination of brain morphology and connectivity using fMRI, determination of lean mass and fat mass using DEXA, resting energy expenditure, functional testing including leg strength and 6 minute walk test, fatigue measurements, and questionnaires of mood and quality of life, gastrointestinal health, sleep, and food preferences. Blood sampling for measurement of amino acid levels, hormones, and metabolites will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal. In addition, fecal samples for analysis of the GI microbiome will be collected monthly for the duration of the study. Insulin Growth Factor 1 (IGF-1) levels will monitored at a month 1 safety visit for all mTBI subjects. The month 1 safety visit will occur +/- 5 days from the expected date based on the baseline study visit. The monthly fecal sampling will occur +/- 7 days from the expected date based on the baseline study visit. The month 6 post study will occur +/- 7 days from the expected date based on the baseline study visit. A member of the study team will contact the subject each month to coordinate fecal sample transport to UTMB, check for adverse events and overall well-being, and ensure compliance and ongoing consent.
PASC Group
Before and at month 6 of the rhGH intervention, PASC subjects will report to the UTMB Institute for Translational Sciences (ITS) Clinical Research Center (CRC) for testing, which will consist of cognitive function assessment (MoCA), determination of lean mass and fat mass using DEXA, resting energy expenditure, functional testing including leg strength and 6 minute walk test, fatigue measurements, and questionnaires of mood and quality of life, gastrointestinal health, sleep, and food preferences. Blood sampling for measurement of amino acid levels, hormones, and metabolites will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal. In addition, fecal samples for analysis of the GI microbiome will be collected monthly for the duration of the study. Insulin Growth Factor 1 (IGF-1) levels will monitored at a month 1 safety visit for all mTBI subjects. The month 1 safety visit will occur +/- 5 days from the expected date based on the baseline study visit. The monthly fecal sampling will occur +/- 7 days from the expected date based on the baseline study visit. The month 6 post study will occur +/- 7 days from the expected date based on the baseline study visit. PASC subjects will continue on rhGH treatment for an additional 3 months. GI microbiome sampling and questionnaires will occur at month 9 and month 12. PASC subjects will have an repeat glucagon stimulation test (GST) to determine growth hormone status at month 12. A member of the study team will contact the subject each month to coordinate fecal sample transport to UTMB, check for adverse events and overall well-being, and ensure compliance and ongoing consent.
Control group
Before and at month 6, controls will report to the UTMB Institute for Translational Sciences (ITS) Clinical Research Center (CRC) for testing, which will consist of questionnaires of food preferences and gastrointestinal health and blood sampling for measurement of amino acid levels, hormones, and metabolites which will be drawn before and 90 minutes (+/ 10 minutes) after a standardized meal. In addition, fecal samples for the analysis of the GI microbiome will be collected monthly for the duration of the study, as well as questionnaire assessing gastrointestinal health. The monthly fecal sampling will occur +/- 7 days from the expected date based on the baseline study visit. The post study (month 6) will occur +/- 7 days from the expected date based on the baseline study visit. A member of the study team will contact the subject each month to coordinate fecal sample transport to UTMB, check for adverse events and overall well-being, and ensure compliance and ongoing consent.
- Conditions
- Traumatic Brain Injury, Fatigue, Cognitive Impairment, COVID-19
- Being tested
- Somatropin
- 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
- Medical subject headings
- Brain Injuries, Traumatic, Fatigue, Cognitive Dysfunction, COVID-19, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Also called Genotropin
Genotropin given by injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline
Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day.
Measured: baseline
Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months
Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day. This will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start6 Aug 2018
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Urban, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554265
- Sponsor's protocol ID
- 17-0313
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2018
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38894576
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
- ClinicalTrials.gov ID
- NCT03554265
- Acronym / sponsor ID
- 17-0313
- Conditions
- Traumatic Brain Injury, Fatigue, Cognitive Impairment, COVID-19
- Keywords
- growth hormone, Traumatic Brain injury, concussion, mTBI, fatigue, cognitive impairment, BIAFAC, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will study subjects (aged 18-70 years) with a history of mild TBI (n=25), post-acute sequelae of SARS-CoV-2 (PASC) (n=25)and healthy controls (n=25). mTBI subjects will undergo a 6-month intervention of rhGH therapy. PASC subjects will undergo a 9-month intervention of rhGH therapy. Controls will be asked to participate in questionnaires, blood draws (amino acid analysis), and fecal sampling (GI microbiome analysis). Controls will not receive any growth hormone treatment.
mTBI group
All patients presenting with a prior mTBI will undergo a phone pre-screen including the Brief Fatigue Inventory (BFI) questions 1-3. If they score ≥ 3 on any BFI questions 1-3, and are interested in participating in the study, they will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC). During the medical screening, eligibility will be confirmed and a glucagon stimulation test (GST) will be performed. A glucagon stimulation with a growth hormone peak of <10 ng/mL is required to qualify for enrollment.
PASC group
All patients presenting with PASC will undergo a phone pre-screen including the Brief Fatigue Inventory (BFI) questions 1-3. If they score ≥ 3 on any BFI questions 1-3, and are interested in participating in the study, they will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC). During the medical screening, eligibility will be confirmed and a glucagon stimulation test (GST) will be performed. A glucagon stimulation with a growth hormone peak of <10 ng/mL is required to qualify for enrollment.
Control group
All controls will undergo a phone pre-screen and if interested in participating in the study, will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC).
Experimental Protocol.
mTBI Group
Before and at completion (month 6) of the rhGH intervention, mTBI subjects will report to the UTMB Institute for Translational Sciences (ITS) Clinical Research Center (CRC) for testing, which will consist of cognitive function assessment (MoCA), determination of brain morphology and connectivity using fMRI, determination of lean mass and fat mass using DEXA, resting energy expenditure, functional testing including leg strength and 6 minute walk test, fatigue measurements, and questionnaires of mood and quality of life, gastrointestinal health, sleep, and food preferences. Blood sampling for measurement of amino acid levels, hormones, and metabolites will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal. In addition, fecal samples for analysis of the GI microbiome will be collected monthly for the duration of the study. Insulin Growth Factor 1 (IGF-1) levels will monitored at a month 1 safety visit for all mTBI subjects. The month 1 safety visit will occur +/- 5 days from the expected date based on the baseline study visit. The monthly fecal sampling will occur +/- 7 days from the expected date based on the baseline study visit. The month 6 post study will occur +/- 7 days from the expected date based on the baseline study visit. A member of the study team will contact the subject each month to coordinate fecal sample transport to UTMB, check for adverse events and overall well-being, and ensure compliance and ongoing consent.
PASC Group
Before and at month 6 of the rhGH intervention, PASC subjects will report to the UTMB Institute for Translational Sciences (ITS) Clinical Research Center (CRC) for testing, which will consist of cognitive function assessment (MoCA), determination of lean mass and fat mass using DEXA, resting energy expenditure, functional testing including leg strength and 6 minute walk test, fatigue measurements, and questionnaires of mood and quality of life, gastrointestinal health, sleep, and food preferences. Blood sampling for measurement of amino acid levels, hormones, and metabolites will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal. In addition, fecal samples for analysis of the GI microbiome will be collected monthly for the duration of the study. Insulin Growth Factor 1 (IGF-1) levels will monitored at a month 1 safety visit for all mTBI subjects. The month 1 safety visit will occur +/- 5 days from the expected date based on the baseline study visit. The monthly fecal sampling will occur +/- 7 days from the expected date based on the baseline study visit. The month 6 post study will occur +/- 7 days from the expected date based on the baseline study visit. PASC subjects will continue on rhGH treatment for an additional 3 months. GI microbiome sampling and questionnaires will occur at month 9 and month 12. PASC subjects will have an repeat glucagon stimulation test (GST) to determine growth hormone status at month 12. A member of the study team will contact the subject each month to coordinate fecal sample transport to UTMB, check for adverse events and overall well-being, and ensure compliance and ongoing consent.
Control group
Before and at month 6, controls will report to the UTMB Institute for Translational Sciences (ITS) Clinical Research Center (CRC) for testing, which will consist of questionnaires of food preferences and gastrointestinal health and blood sampling for measurement of amino acid levels, hormones, and metabolites which will be drawn before and 90 minutes (+/ 10 minutes) after a standardized meal. In addition, fecal samples for the analysis of the GI microbiome will be collected monthly for the duration of the study, as well as questionnaire assessing gastrointestinal health. The monthly fecal sampling will occur +/- 7 days from the expected date based on the baseline study visit. The post study (month 6) will occur +/- 7 days from the expected date based on the baseline study visit. A member of the study team will contact the subject each month to coordinate fecal sample transport to UTMB, check for adverse events and overall well-being, and ensure compliance and ongoing consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| mTBI subjects | Experimental | Drug: SomatropinmTBI 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 |
| Household Control Subjects | No intervention | –household control subjects will not receive any intervention. |
| PASC subjects | Experimental | Drug: SomatropinPASC 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatropinAlso: GenotropinGenotropin given by injection | Drug | PASC subjects, mTBI subjects |
Primary outcome
Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Time frame: baseline
Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.
Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months
Time frame: 6 months
Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline
Time frame: baseline
Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months
Time frame: 6 months
Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.
2 secondary outcomes
Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline
Time frame: baseline
Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38894576Wright 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall J Urban, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatropin in people with Traumatic Brain Injury and Fatigue, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.