Research

Current Clinical Trials

Our Pulmonary & Critical Care Medicine faculty participate in clinical trials that are sponsored by the NIH, industry, and the University.  Below is a listing of our current clinical trials in pulmonary & critical care medicine.  For more information on specific trials, please contact Elizabeth Vidales or Mary Rangel below.

Outpatient
Illness Study IP Inclusion Exclusion
COVID-Related Impaired Pulmonary Function HUMANETICS
Actively recruiting
BIO 300
  • Age: ≥ 18 years
  • D/C within 2 years after being hospitalized for COVID-19-related complications
  • Severe background disease like cardiac or pulmonary insufficiency (WHO 3 or 4)
  • Severe liver and kidney diseases, severe COPD, severe neurological disease
  • Poorly controlled intercurrent illnesses (e.g., interstitial lung disease, uncontrolled hypertension, poorly controlled diabetes mellitus, angina, myocardial infarction, congestive heart failure NYHA 3 or 4)
PAH INSMED 202
Actively recruiting
INS 1009
  • Age: 18-75 years
  • WHO Group 1 PH (PAH)
  • NYHA/WHO FC II or III
  • PH Hx other than idiopathic, hereditary, drug/toxin-induced, or CTD-associated PAH
  • Hx of heart disease
  • HIV infection (past or present)
INSMED 203
Actively recruiting
INS 1009
  • Completed trial study INSMED 201, INSMED 202, or other lead-in PAH TPIP study
  • Adverse drug reaction in previous PAH TPIP study
  • Initiation of parenteral administration of prostacyclin analogues since completion of INSMED 201 (or 202) or any other TPIP study
UTC 301
Actively recruiting
Ralinepag
  • Age: ≥ 18 years
  • WHO Group 1 PAH
  • NYHA/WHO FC II – IV
  • HIV-associated PAH
  • Severe chronic liver disease, portal hypertension, cirrhosis
  • Active HBV or HCV infection
  • On treatment with inhaled or oral prostacyclin
UTC 303
Actively recruiting
Ralinepag
  • Completed trial study UTC 301
  • Adverse drug reaction in UTC 301
  • Lung or heart/lung transplant
  • Long-term parenteral or inhaled therapy w/ prostacyclin
MERCK 007
Actively recruiting
MK-5475
  • Age: 18-75 years
  • PAH Group 1.1 – 1.4
  • WHO FC II – IV
  • PH Groups: 2, 3, 4, or 5
  • Left heart disease
  • Chronic liver disease, portal hypertension, cirrhosis, or abnormal hepatic labs
  • Current smoker (including e-cigarettes)
  • Use of inhaled prostacyclin analogues, inhaled NO, or oral sGC modulators
PH AERAMI UNIPHIED
Not recruiting yet
AER-901
  • Age: 18-80 years
  • PH Group 1 or 3
  • WHO FC 2-4
  • 6MWD 100-500m
  • Cardiac failure due to left heart disease or significant valvular heart disease unrelated to PH
  • Uncontrolled systemic hypertension
  • Hx of CTEPH or thromboembolic disease
  • Hx or current signs of asthma or bronchial hyperreactivity
PF – ILDs BI 0023
Actively recruiting
BI 1015550
  • Age: ≥ 18 years
  • Progressive fibrosing ILD other than IPF
  • Relevant airways obstruction
  • Treated w/ prednisone >15mg/day or equivalent within 4 weeks; cyclophosphamide, tocilizumab, mycophenolate, pirfenidone within 8 weeks; rituximab within 6 months
Progressive PF BMS IM027-1015
Not recruiting yet
BMS-986278
  • Age: ≥ 21 years
  • Features consistent w/ progressive ILD within 24 months
  • ppFVC ≥ 40%
  • IPF Dx confirmed by UIP pattern
  • Clinically significant PAH
  • Clinically significant non-parenchymal lung disease
IPF MOONSCAPE
Not recruiting yet
Vixarelimab
(Formerly KPL-716)
  • Age: 40-85 years
  • IPF
  • Receipt of nintedanib in combination w/ pirfenidone
  • Chronic heart failure (New York Heart Assoc. Class IV)
  • Immunodeficiency
  • Pts taking pirfenidone and receiving strong inhibitor or inducer of CYP1A2
  • Pts taking nintedanib and receiving potent inhibitor or reducer of P-gp
BMS IM027-068
Not recruiting yet
BMS-986278
  • Age: ≥ 40 years
  • IPF Dx within 7 years
  • ppFVC ≥ 40%
  • FEV1/FVC ≥ 0.7
  • ILD associated w/ known primary causes
  • Emphysema ≥ 50% on HRCT
  • Clinically significant PAH
  • Known presence of significant left-ventricular systolic dysfunction
PH-COPD MERCK 013
Actively recruiting
MK-5475
  • Age: 40-80 years
  • PH-COPD Group 3.1
  • WHO FC II – IV
  • PAH Groups: 1, 2, 4, 5
  • Left heart disease
  • Chronic renal insufficiency, chronic liver disease, portal hypertension, or cirrhosis
  • Use of IV inotropes or on PAH-specific therapies, inhaled prostacyclin analogues, inhaled nitric oxide, or oral sGC modulators
COPD ARNASA
Not recruiting yet
Astegolimab
  • Age: 40-80 years
  • COPD Dx ≥12 months
  • Current or former smoker
  • Current asthma or Hx of pulmonary disease other than COPD
  • Long-term treatment w/ oxygen at > 4.0 L/min
  • Immunodeficiency
Refractory Chronic Cough BELLUS CALM-1
Actively recruiting
BLU-5937
  • Age: 18-80 years
  • Persistent cough for ≥ 1 year
  • Current smoker (tobacco, vapes, cannabis, nicotine) or hx of >20 pack years
  • COPD dx, bronchiectasis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis
  • moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment
  • TB or uncontrolled asthma
COVID-Related Sleep Disturbances RECOVER Sleep
Not recruiting yet
Phenotype-targeted interventions
  • Age ≥ 18 years
  • Previous suspected or confirmed SARS-Cov-2 infection with subsequent new/worse sleep problems
  • PROMIS 8a SRI or 8b SD T Score ≥ 60
  • Untreated sleep apnea (AHI ≥ 15 or severe sleep-related hypoxemia)
  • Current night or rotating shift work
  • Hx of narcolepsy prior to SARS-CoV-2 infection

Inpatient
Illness Study IP Inclusion Exclusion
COVID-19 NECTAR
Actively recruiting
Fostamatinib
  • Age: ≥ 18 years
  • Hospitalized for COVID-19
  • Hospitalized w/ hypoxemia for > 72 hrs
  • Acute COVID-19 sx for > 14 days
  • ESRD on dialysis
Out of Hospital Cardiac Arrest Role of Palliative Medicine on patients admitted with diagnosis of Out of Hospital Cardiac Arrest 
Actively recruiting
N/A, data collection only
  • Age: ≥ 18 years
  • Patients admitted to the ICU at MHH – TMC with a Dx of cardiac arrest or post-cardiac arrest syndrome
  • Patients with cardiac arrest or post-cardiac arrest syndrome that are admitted directly from an emergency department.
  • Dx of cardiac arrest or post-cardiac arrest syndrome that expires during the first 24 hours. 
  • Dx of in-hospital cardiac arrest.
  • Patients with no next of kin who are assigned a clergy surrogate or require an ethics committee intervention for assignment of a legal decision maker.
  • Patients who are admitted to an outside hospital after cardiac arrest then transferred to MHH – TMC
Patients admitted to MICU Role of Social Workers and Case Managers in an Intensive Care Unit:
A Multicenter Prospective Study
Actively recruiting
N/A, data collection only
  • Patients admitted to the Medical Intensive Care Unit (MICU) at Memorial Hermann Texas Medical Center.
  • All patients admitted to the Medical Intensive Care Unit (MICU) at Memorial Hermann Texas Medical Center with requirements of ECMO
Post Cardiac Arrest Syndrome PCAS + IVF
Actively recruiting
IV fluids
  • Age: ≥18 years
  • Patients admitted to the medical intensive care unit, with diagnosis of out of hospital cardiac arrest.
  • Patients transferred from another institution
COVID-Related Respiratory Infection STRIVE
Not recruiting yet
S-217622
  • Age: ≥ 18 years
  • Hospitalization for COVID-19 with signs of lower respiratory tract infection
  • SARS-CoV-2 infection w/ symptom onset having occurred within 14 days
  • Expected discharge within 24 hrs
  • Moribund condition or treatment focusing on end-of-life sx management
STRIVE 2
Not recruiting yet
Abatacept
  • Age: ≥ 18 years
  • Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection
  • Expected D/C within 24 hours
  • Moribund condition w/ life expectancy less than 48 hours
Mechanical Ventilation PREVENT
Not recruiting yet
VentFree Respiratory Muscle Stimulator
  • Age: ≥ 22 years
  • Receiving invasive mechanical ventilation for ≥ 24 hours
  • Receiving invasive mechanical ventilation in ICU for ≤ 72 hours
  • Expected to be disconnected from mechanical ventilation ≤ 24 hrs
  • BMI ≥ 40
  • Implanted electronic device (e.g., pacemaker or defibrillator)
  • Epilepsy Dx or on treatment for anaphylaxis
  • Ventilated due to uncomplicated elective surgery
COSMIC
Not recruiting yet
Cuff Leak Test
  • Age: ≥ 18 years
  • Mechanically ventilated in the ICU (intubated for >5 days) w/ order to extubate
  • Patients admitted to ICU w/ known or highly suspected laryngeal injury (burn patients, smoke inhalation, blunt or penetrating neck/airway trauma, recent head/neck surgeries, airway edema)
  • Pre-existing tracheolaryngeal abnormalities
  • Mechanical ventilation via tracheostomy
Mechanical Ventilation with Continuous Opioid Treatment IMPACTOR
Not recruiting yet
Methadone
  • Age: ≥ 18 years
  • On IMV for > 72 hours
  • Infused Fentanyl or Hydromorphone for > 72 hours
  • Receiving schedule II narcotics on a chronic basis > 6 months prior to ICU admission
  • Pts w/ cervical spinal cord injury of neuromuscular disease
  • End Stage Liver Disease at ICU admission
  • Prolonged QTc interval ≥ 500
Pulmonary Embolism PE-TRACT
Not recruiting yet
Catheter-Directed Therapy
  • Age: ≥ 18 years
  • Symptomatic PE diagnosed by contrast-enhanced CTA
  • Irreversible INR > 3.0
  • Sx duration >14 days for current PE episode
  • Inability to independently walk prior to current PE episode
  • Heparin allergy or hx of Heparin-Induced Thrombocytopenia

Additional Links:
Pulmonary Center of Excellence
Lung Tissue Biorepository – Pulmonary Center of Excellence


For more information, please contact:
For inquiries, you can reach Elizabeth at 713-486-6154 (Elizabeth.Vidales@uth.tmc.edu) or
Mary at 713-500-6851 (Mary.Rangel@uth.tmc.edu).