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Hormone Therapy

Growth Hormone Therapy for Traumatic Brain Injury and Post-COVID Syndrome

Phase 3
Waitlist Available
Led By Randall J Urban, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will study whether growth hormone therapy can help improve symptoms for people who have had a mild traumatic brain injury or who have had sequelae (long-term effects) of SARS-CoV-2.

Who is the study for?
This trial is for adults aged 18-70 who've had mild traumatic brain injury or COVID with fatigue, at least 6 months post-injury or diagnosis. They must have abnormal growth hormone levels and be able to consent. Exclusions include recent cancer (except certain skin cancers), unassisted walking difficulty, major organ diseases, uncontrolled diabetes, current pregnancy, drug/alcohol abuse, psychosis history, recent steroid treatment, inflammatory bowel conditions.Check my eligibility
What is being tested?
The study tests if growth hormone therapy can improve cognition and quality of life in patients with mTBI or Post-COVID Syndrome over a period of 6-9 months. It involves pre- and post-treatment cognitive testing and monthly fecal sampling to analyze gut microbiome changes compared to control subjects without the therapy.See study design
What are the potential side effects?
Potential side effects from growth hormone therapy may include joint pain, muscle pain, swelling due to fluid retention (edema), increased blood sugar levels (which could trigger or worsen diabetes), carpal tunnel syndrome-like symptoms such as numbness or tingling in hands/arms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 months
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline
Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 months
+1 more
Secondary outcome measures
Basal Metabolic rate as measured by Resting Energy Expenditure at 6 months
Basal Metabolic rate as measured by Resting Energy Expenditure at baseline
Other outcome measures
Cognitive Function as measured by Montreal Cognitive Assessment at 6 months
Cognitive Function as measured by Montreal Cognitive Assessment at baseline
Depression measured by the Beck Depression Inventory-II at 12 months
+42 more

Side effects data

From 2017 Phase 4 trial • 82 Patients • NCT02311894
21%
Headache
15%
Vomiting
10%
Upper respiratory tract infection
9%
Injection site bruising
7%
Rash
7%
Pharyngitis streptococcal
6%
Nasopharyngitis
6%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Somatropin

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: mTBI subjectsExperimental Treatment1 Intervention
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
Group II: PASC subjectsExperimental Treatment1 Intervention
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
Group III: Household Control SubjectsActive Control1 Intervention
household control subjects will not receive any intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatropin
2015
Completed Phase 4
~67770

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,515 Total Patients Enrolled
Randall J Urban, MDPrincipal InvestigatorUniversity of Texas
4 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

Somatropin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03554265 — Phase 3
Traumatic Brain Injury Research Study Groups: PASC subjects, mTBI subjects, Household Control Subjects
Traumatic Brain Injury Clinical Trial 2023: Somatropin Highlights & Side Effects. Trial Name: NCT03554265 — Phase 3
Somatropin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554265 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this experiment at most?

"This particular clinical trial is no longer recruiting patients. The study began on 8/6/2018 and ended recruitment on 8/22/2022. However, there are presently 2258 other trials for covid-19 and 35 studies investigating Somatropin that are actively looking for participants."

Answered by AI

Is this a full clinical trial or are there still positions open for participants?

"Unfortunately, this study is not taking on any more patients at the current time. However, there are over 2000 other medical trials currently recruiting patients that you may be eligible for."

Answered by AI

Does this experiment only allow adults that are above a certain age?

"People aged 18-70 fit the age range specified in this trial's eligibility criteria. Out of the 264 trials that exclude people under 18, and the 1948 trials for seniors, this one is unique."

Answered by AI

Has this investigation been conducted before?

"Somatropin, a synthetic growth hormone, has been under study since it was first trialed in 2005 by BioPartners GmbH. After the initial 144-person Phase 1 study, Somatropin received its drug approval and is now being studied in 35 active trials across 170 cities and 45 countries."

Answered by AI

Could you explain the requirements for patients who want to join this trial?

"The current study's requirements for participants are that they should have covid-19 and be 18-70 years old. So far, 83 individuals have met these qualifications and enrolled in the trial."

Answered by AI

Are there long-term repercussions to taking Somatropin?

"Somatropin has been studied in Phase 3 clinical trials, so Power rates its safety as a 3."

Answered by AI

For what purpose is Somatropin most often prescribed?

"Somatropin is often used as a way to intervene during general surgery. Additionally, it has been shown to be an effective medical treatment for conditions like short stature and open epiphyses."

Answered by AI

Does Somatropin have a long and successful clinical history?

"There are currently 35 clinical trials studying the efficacy of Somatropin. Of those, 14 have entered Phase 3. The majority of these studies originate from Philadelphia, Pennsylvania; however, there are 646 locations around the world conducting research on this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
2018. "Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554265.
~12 spots leftby Apr 2025
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