Novel Experimental COVID-19 Therapies Affecting Host Response

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19, SARS-CoV-2 Infection, Coronavirus Infection

In brief

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. The primary analysis will include data from NCT05593770.

Key facts

Study ID

NCT04924660

Run by

Sean Collins

People needed

1060

Starts

2021-07-15

Expected to finish

2023-12-31

Last updated by the study team

2025-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalized for COVID-19
• ≥18 years of age
• SARS-CoV-2 infection, documented by:
• a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
• documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team).
• Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
• Symptoms or signs of acute COVID-19, defined as one or more of the following:
• cough
• reported or documented body temperature of 100.4 degrees Fahrenheit or greater
• shortness of breath
• chest pain
• infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)

You may not qualify if…

• Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization
• Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)
• Pregnancy
• Breastfeeding
• Prisoners
• End-stage renal disease (ESRD) on dialysis
• Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life.
• The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient
• Known allergy/hypersensitivity to IMP or its excipients
• The following exclusion criteria differ from the master protocol criteria:
• TXA127-specific exclusion criteria(4/20/2022 Closed to Accrual):
• Patient unable to participate or declines participation in the TXA127/Ang(1-7) arm.
• History of sensitivity (including angioedema) or allergic reaction to medication targeting the RAAS system including study medications or other allergy in the opinion of the investigator that contraindicates participation (not applicable to fostamatinib arm)
• Hemodynamic instability - defined as MAP < 65 mmHg at time of randomization confirmed on two measurements 5 minutes apart OR vasopressors at or above norepinephrine equivalent of 0.1 mcg/kg/min in prior 4 hours to maintain MAP > 65 mmHg.
• Known severe renal artery stenosis.
• Known significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic or mitral stenosis.
• Randomized in another trial evaluating RAAS modulation in the prior 30 days
• TRV027-specific exclusion criteria (4/20/2022 Closed to Accrual):
• Participants on ARBs will be excluded from this study arm.
• Patient unable to participate or declines participation in the TRV027 arm.
• History of sensitivity (including angioedema) or allergic reaction to medication targeting the RAAS system including study medications or other allergy in the opinion of the investigator that contraindicates participation (not applicable to fostamatinib arm)
• Hemodynamic instability - defined as MAP < 65 mmHg at time of randomization confirmed on two measurements 5 minutes apart OR vasopressors at or above norepinephrine equivalent of 0.1 mcg/kg/min in prior 4 hours to maintain MAP > 65 mmHg.
• Known severe renal artery stenosis.
• Known significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic or mitral stenosis.
• Randomized in another trial evaluating RAAS modulation in the prior 30 days

Where it is running

• Chandler Regional Medical Center — Chandler, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Public Health Trust of Miami-Dade County, Florida - Jackson Memorial Hospital — Miami, Florida, United States
• Ponce de Leon Clinical Research Site — Atlanta, Georgia, United States
• Emory Johns Creek — Atlanta, Georgia, United States
• Emory St. Joseph's Hospital — Atlanta, Georgia, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• AMITA Health St. Alexius Medical Center — Hoffman Estates, Illinois, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Jadestone Clinical Research, LLC — Silver Spring, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• Baystate Health — Springfield, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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