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
IPF	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
COVID-Related Respiratory Infection	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
Mechanical Ventilation	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

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).