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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | Genotropin given by injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function as Measured by Montreal Cognitive Assessment at Baseline | The Montreal Cognitive Assessment (MoCA) will be used to assess cognition at baseline in mTBI and PASC subjects only. The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA consists of 9 questions with the following subcategories: visuospatial/executive, naming, memory, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. Version 7.1 will be used at the Month 0 testing and Version 7.2 will be used at the Month 6 testing. Scores range from 0 to 30, higher score being a better outcome. |
mTBI Inclusion criteria
mTBI Exclusion criteria
Control Inclusion criteria
Control Exclusion criteria
PASC Inclusion criteria
PASC Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Randall J Urban, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38894576 | Result | 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. |
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Recruitment for mTBI and community control subjects began August 2018 and ended August 2022.
Recruitment for PASC subjects began May 2021 and ended September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | mTBI Subjects | 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 Somatropin: Genotropin given by injection |
| FG001 | Community Control Subjects | Community control subjects will not receive any intervention. |
| FG002 | PASC Subjects | 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 Somatropin: Genotropin given by injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | mTBI Subjects | 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 Somatropin: Genotropin given by injection |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Community Control subjects did not undergo this procedure. | Posted | Mean | Standard Deviation | kilograms | baseline |
|
mTBI arm: 6 months community control arm: 6 months PASC arm: up to 15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mTBI Subjects | 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 Somatropin: Genotropin given by injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall Urban, MD | University of Texas Medical Branch | 409-772-5476 | rurban@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2022 | Jan 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D005221 | Fatigue |
| D060825 | Cognitive Dysfunction |
| D000086382 | COVID-19 |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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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
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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. |
| 6 months |
| baseline |
| Cognitive Function as Measured by Montreal Cognitive Assessment at 6 Months | The Montreal Cognitive Assessment (MoCA) will be used to assess cognition after 6 months of growth hormone treatment in mTBI and PASC subjects only. The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA consists of 9 questions with the following subcategories: visuospatial/executive, naming, memory, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. Version 7.1 will be used at the Month 0 testing and Version 7.2 will be used at the Month 6 testing. Scores range from 0 to 30, higher score being a better outcome. | 6 months |
| Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at Baseline | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in mTBI and PASC subjects at baseline. | baseline |
| Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at 6 Months | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in mTBI and PASC subjects after 6 months of growth hormone treatment. | 6 months |
| Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at 9 Months | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in PASC subjects after 9 months of growth hormone treatment. | 9 months |
| Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at 12 Months | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in PASC subjects after 9 months of growth hormone treatment and 3 months off treatment (total time: 12 months). | 12 months |
| Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured at baseline. | baseline |
| Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at 6 Months | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured after 6 months of growth hormone treatment. | 6 months |
| Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at 9 Months | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured after 9 months of growth hormone treatment in PASC subjects only. | 9 months |
| Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at 12 Months | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured after 9 months of growth hormone treatment and then 3 months without treatment (total 12 months) in PASC subjects only. | 12 months |
| Gastrointestinal Health as Measured by the Gastrointestinal Symptom Rating Scale at Baseline | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 75 (worst outcome). GSRS will be measured monthly at baseline mTBI, PASC and control subjects. | baseline |
| Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale at 6 Months | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 7 (worst outcome). GSRS will be measured monthly in all subjects. | 6 months |
| Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale at 9 Months | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 7 (worst outcome). GSRS will be measured in month 9 in PASC subjects only. | 9 months |
| Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale at 12 Months | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 7 (worst outcome). GSRS will be measured in month 12 in PASC subjects only. | 12 months |
| Mood Measured by Profile of Mood States at Baseline | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured at baseline in mTBI and PASC subjects only. | baseline |
| Mood Measured by Profile of Mood States at 6 Months | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured after 6 months of treatment with Growth hormone in mTBI and PASC subjects only. | 6 months |
| Mood Measured by Profile of Mood States at 9 Months | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured after 9 months of treatment with Growth hormone in PASC subjects only. | 9 months |
| Mood Measured by Profile of Mood States at 12 Months | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured after 9 months of treatment with Growth hormone treatment and 3 months without treatment (total 12 months) in PASC subjects only. | 12 months |
| Sleep Quality Measured by Pittsburgh Sleep Quality Index at Baseline | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured at baseline in mTBI and PASC subjects only. | baseline |
| Sleep Quality Measured by Pittsburgh Sleep Quality Index at 6 Months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured after 6 months of treatment with growth hormone in mTBI and PASC subjects only. | 6 months |
| Sleep Quality Measured by Pittsburgh Sleep Quality Index at 9 Months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured after 9 months of treatment with growth hormone in PASC subjects only. | 9 months |
| Sleep Quality Measured by Pittsburgh Sleep Quality Index at 12 Months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured after 9 months of treatment with growth hormone and 3 months without treatment (total 12 months) in PASC subjects only. | 12 months |
| Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Defiency in Adults at Baseline | Symptoms of growth hormone deficiency will be measured in mTBI and PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured at baseline in mTBI and PASC subjects only. | baseline |
| Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at 6 Months | Symptoms of growth hormone deficiency will be measured in mTBI and PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only. | 6 months |
| Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at 9 Months | Symptoms of growth hormone deficiency will be measured in PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured after 9 months of growth hormone treatment in PASC subjects only. | 9 months |
| Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at 12 Months | Symptoms of growth hormone deficiency will be measured in PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured after 9 months of growth hormone treatment and then 3 months without treatment (total 12 months) in PASC subjects only. | 12 months |
| Depression Measured by the Beck Depression Inventory-II at Baseline | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured at baseline in mTBI and PASC subjects only. | baseline |
| Depression Measured by the Beck Depression Inventory-II at 6 Months | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only. | 6 months |
| Depression Measured by the Beck Depression Inventory-II at 9 Months | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured after 9 months of growth hormone treatment in PASC subjects only. | 9 months |
| Depression Measured by the Beck Depression Inventory-II at 12 Months | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured after 9 months of growth hormone treatment and 3 months without treatment (total 12 months) in PASC subjects only. | 12 months |
| Walking Distance at 25% Perceptual Effort as Measured by Walking Test at Baseline | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at baseline. Measured in mTBI and PASC subjects only. | baseline |
| Walking Distance at 25% Perceptual Effort as Measured by Walking Test at 6 Months | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at month 6. Measured in mTBI and PASC subjects only. | 6 months |
| Walking Distance at 50% Perceptual Effort as Measured by Walking Test at Baseline | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at baseline. Measured in mTBI and PASC subjects only. | baseline |
| Walking Distance at 50% Perceptual Effort as Measured by Walking Test at 6 Months | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at month 6. Measured in mTBI and PASC subjects only. | 6 months |
| Walking Distance at 100% Effort as Measured by Walking Test at Baseline | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at baseline. Measured in mTBI and PASC subjects only. | baseline |
| Walking Distance at 100% Effort as Measured by Walking Test at 6 Months | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at month 6. Measured in mTBI and PASC subjects only. | 6 months |
| Community Control Subjects |
Community control subjects will not receive any intervention. |
| BG002 | PASC Subjects | 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 Somatropin: Genotropin given by injection |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | (kg/m2) |
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Community control subjects will not receive any intervention.
| OG002 | PASC Subjects | 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 Somatropin: Genotropin given by injection |
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| Primary | 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. | Community control subjects did not undergo this procedure. | Posted | Mean | Standard Deviation | kilograms | 6 months |
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| Primary | 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. | Community controls did not undergo this procedure. | Posted | Mean | Standard Deviation | kilograms | baseline |
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| Primary | 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. | Community Controls did not undergo this procedure. | Posted | Mean | Standard Deviation | kilograms | 6 months |
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| Secondary | 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. | Community Control subjects did not undergo this procedure. | Posted | Mean | Standard Deviation | kilocalories per day | baseline |
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| Secondary | 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. | Community Control subjects did not undergo this procedure. 2 PASC subjects did not undergo 6m measurement due to equipment failure. | Posted | Mean | Standard Deviation | kilocalories per day | 6 months |
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| Other Pre-specified | Cognitive Function as Measured by Montreal Cognitive Assessment at Baseline | The Montreal Cognitive Assessment (MoCA) will be used to assess cognition at baseline in mTBI and PASC subjects only. The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA consists of 9 questions with the following subcategories: visuospatial/executive, naming, memory, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. Version 7.1 will be used at the Month 0 testing and Version 7.2 will be used at the Month 6 testing. Scores range from 0 to 30, higher score being a better outcome. | Community control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Cognitive Function as Measured by Montreal Cognitive Assessment at 6 Months | The Montreal Cognitive Assessment (MoCA) will be used to assess cognition after 6 months of growth hormone treatment in mTBI and PASC subjects only. The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA consists of 9 questions with the following subcategories: visuospatial/executive, naming, memory, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. Version 7.1 will be used at the Month 0 testing and Version 7.2 will be used at the Month 6 testing. Scores range from 0 to 30, higher score being a better outcome. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at Baseline | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in mTBI and PASC subjects at baseline. | Community Controls did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at 6 Months | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in mTBI and PASC subjects after 6 months of growth hormone treatment. | Community Controls did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at 9 Months | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in PASC subjects after 9 months of growth hormone treatment. | Community control subjects did not complete this measure. mTBI subjects did not complete 9m measurements. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) at 12 Months | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Brief Fatigue Inventory is measured in PASC subjects after 9 months of growth hormone treatment and 3 months off treatment (total time: 12 months). | Community control subjects did not complete this measure. mTBI subjects did not complete 12m measurements. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured at baseline. | Community control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at 6 Months | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured after 6 months of growth hormone treatment. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at 9 Months | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured after 9 months of growth hormone treatment in PASC subjects only. | mTBI and community control subjects are complete at month 6. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at 12 Months | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. The MFSI is measured after 9 months of growth hormone treatment and then 3 months without treatment (total 12 months) in PASC subjects only. | mTBI and community control subjects are complete at month 6. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Gastrointestinal Health as Measured by the Gastrointestinal Symptom Rating Scale at Baseline | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 75 (worst outcome). GSRS will be measured monthly at baseline mTBI, PASC and control subjects. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale at 6 Months | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 7 (worst outcome). GSRS will be measured monthly in all subjects. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale at 9 Months | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 7 (worst outcome). GSRS will be measured in month 9 in PASC subjects only. | mTBI and community control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Gastrointestinal Health Measured by the Gastrointestinal Symptom Rating Scale at 12 Months | The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The average of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 1 (best outcome) to 7 (worst outcome). GSRS will be measured in month 12 in PASC subjects only. | mTBI and community control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Mood Measured by Profile of Mood States at Baseline | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured at baseline in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Mood Measured by Profile of Mood States at 6 Months | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured after 6 months of treatment with Growth hormone in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Mood Measured by Profile of Mood States at 9 Months | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured after 9 months of treatment with Growth hormone in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Mood Measured by Profile of Mood States at 12 Months | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). POMS will be measured after 9 months of treatment with Growth hormone treatment and 3 months without treatment (total 12 months) in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Sleep Quality Measured by Pittsburgh Sleep Quality Index at Baseline | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured at baseline in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Sleep Quality Measured by Pittsburgh Sleep Quality Index at 6 Months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured after 6 months of treatment with growth hormone in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Sleep Quality Measured by Pittsburgh Sleep Quality Index at 9 Months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured after 9 months of treatment with growth hormone in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Sleep Quality Measured by Pittsburgh Sleep Quality Index at 12 Months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality. PSQI will be measured after 9 months of treatment with growth hormone and 3 months without treatment (total 12 months) in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Defiency in Adults at Baseline | Symptoms of growth hormone deficiency will be measured in mTBI and PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured at baseline in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at 6 Months | Symptoms of growth hormone deficiency will be measured in mTBI and PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at 9 Months | Symptoms of growth hormone deficiency will be measured in PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured after 9 months of growth hormone treatment in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Symptoms of Growth Hormone Deficiency Measured by the Questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at 12 Months | Symptoms of growth hormone deficiency will be measured in PASC subjects using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. The QoL-ADGHA will be measured after 9 months of growth hormone treatment and then 3 months without treatment (total 12 months) in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Depression Measured by the Beck Depression Inventory-II at Baseline | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured at baseline in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Other Pre-specified | Depression Measured by the Beck Depression Inventory-II at 6 Months | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | Depression Measured by the Beck Depression Inventory-II at 9 Months | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured after 9 months of growth hormone treatment in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
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| Other Pre-specified | Depression Measured by the Beck Depression Inventory-II at 12 Months | The Beck Depression Inventory- II assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe. The BDI will be measured after 9 months of growth hormone treatment and 3 months without treatment (total 12 months) in PASC subjects only. | mTBI and Community Control subjects complete the study at month 6. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Walking Distance at 25% Perceptual Effort as Measured by Walking Test at Baseline | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at baseline. Measured in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | meters | baseline |
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| Other Pre-specified | Walking Distance at 25% Perceptual Effort as Measured by Walking Test at 6 Months | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at month 6. Measured in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | meters | 6 months |
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| Other Pre-specified | Walking Distance at 50% Perceptual Effort as Measured by Walking Test at Baseline | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at baseline. Measured in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | meters | baseline |
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| Other Pre-specified | Walking Distance at 50% Perceptual Effort as Measured by Walking Test at 6 Months | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at month 6. Measured in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | meters | 6 months |
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| Other Pre-specified | Walking Distance at 100% Effort as Measured by Walking Test at Baseline | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at baseline. Measured in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | meters | baseline |
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| Other Pre-specified | Walking Distance at 100% Effort as Measured by Walking Test at 6 Months | Walking performance will be assessed in mTBI and PASC patients during 6 minutes of walking in long corridor hallways. This is a standard test of walking performance that has been validated in similar studies. Here, the test will be slightly modified, with subjects asked to walk at a 25% perceived effort from minute 0 - 2, at a 50% perceived effort from minute 2 - 4, and at a 100% effort (as quickly as they can safely walk without running) from minute 4 -6. Distance traveled for each 2-minute category will be recorded. The 6-minute walking test will be completed at month 6. Measured in mTBI and PASC subjects only. | Community Control subjects did not complete this measure. | Posted | Mean | Standard Deviation | meters | 6 months |
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| 0 |
| 28 |
| 0 |
| 28 |
| 26 |
| 28 |
| EG001 | Community Control Subjects | Community control subjects will not receive any intervention. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | PASC Subjects | 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 Somatropin: Genotropin given by injection | 0 | 17 | 0 | 17 | 17 | 17 |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fast heartbeat | Cardiac disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Feeling Faint | Cardiac disorders | Systematic Assessment |
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| Injection site reactions | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Tingling, numbness or prickling | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Reflux | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |