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Status:

COMPLETED

Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection

Lead Sponsor:

Denver Health and Hospital Authority

Collaborating Sponsors:

Genentech, Inc.

University of Colorado, Denver

Conditions:

Severe Acute Respiratory Syndrome

Respiratory Failure

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

The global pandemic COVID-19 has overwhelmed the medical capacity to accommodate a large surge of patients with acute respiratory distress syndrome (ARDS). In the United States, the number of cases of...

Detailed Description

As the COVID-19 pandemic accelerates, cases have grown exponentially around the world. Other countries' experience suggests that 5-16% of COVID-19 in-patients will undergo prolonged intensive care wit...

Eligibility Criteria

Inclusion

  • We will include adult patients ages 18-75 years old with known or suspected COVID-19 infection with a PaO2/FiO2 ratio \< 150 or inferred PaO2/FiO2 ratio from SpO2 if ABG is unavailable (Table) persisting for \> 4 hours despite optimal mechanical ventilation management according to each institution's ventilation protocols, and a neurological exam without focal signs or new deficits at time of enrollment (if patient is on paralytics, patient has been aroused sufficiently to allow a neurological examination to exclude new focal deficits or has MRI/CT scan in the last 4.5 hours with no evidence of stroke. Finally, patients must be on the ventilator for \<=10 days to be eligible. Based on experience with critically ill patients, longer ventilation time may be associated with increased risk of bleeding. Patients will be enrolled based on clinical features, without consideration of language (using hospital interpreters and translated consent), race/ethnicity, or gender. A neurological exam or CT/MRI scan to demonstrate no evidence of an acute stroke is needed due to a recent case-report of large-vessel stroke as a presenting feature of COVID-19 in young individuals.

Exclusion

  • Active bleeding
  • Acute myocardial infarction or history of myocardial infarction within the past 3 weeks or cardiac arrest during hospitalization
  • Hemodynamic instability with Noradrenaline \>0.2mcg/Kg/min
  • Acute renal failure requiring dialysis
  • Liver failure (escalating liver failure with total Bilirubin \> 3 mg/dL)
  • Suspicion of cirrhosis due to history of cirrhosis diagnosis, hepatic encephalopathy, documentation of portal hypertension, bleeding from esophageal varices, ascites, imaging or operative finding suggestive of liver cirrhosis, or constellation of abnormal laboratory test results suggestive of depressed hepatic function
  • Cardiac tamponade
  • Bacterial endocarditis
  • Severe uncontrolled hypertension defined as SBP\>185mmHg or DBP\>110mmHg
  • CVA (stroke), history of severe head injury within prior 3 months, or prior history of intracranial hemorrhage
  • Seizure during pre-hospital course or during hospitalization for COVID-19
  • Diagnosis of brain tumor, arterio-venous malformation (AVM) or ruptured aneurysm
  • Currently on ECMO
  • Major surgery or major trauma within the past 2 weeks
  • GI or GU bleed within the past 3 weeks
  • Known bleeding disorder
  • P2Y12 receptor inhibitor medication (anti-platelet) within 5 days of enrollment
  • Arterial puncture at a non-compressible site within the past 7 days
  • Lumbar puncture within past 7 days
  • Pregnancy
  • INR \> 1.7 (with or without concurrent use of warfarin)
  • Platelet count \< 100 x 109/L or history of HITT
  • Fibrinogen \< 300mg/dL
  • Known abdominal or thoracic aneurysm
  • History of CNS malignancy or CNS metastasis within past 5 years
  • History of non-CNS malignancy within the past 5 years that commonly metastasizes to the brain (lung, breast, melanoma)
  • Prisoner status

Key Trial Info

Start Date :

May 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04357730

Start Date

May 14 2020

End Date

September 30 2021

Last Update

January 20 2022

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Scripps Memorial Hospital La Jolla

La Jolla, California, United States, 92037

2

University of Colorado, Denver

Aurora, Colorado, United States, 80045

3

Denver Health Medical Center

Denver, Colorado, United States, 80204

4

National Jewish Health

Denver, Colorado, United States, 80206