Status:
COMPLETED
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS
Lead Sponsor:
Prisma Health-Upstate
Conditions:
Cytokine Release Syndrome
COVID19
Eligibility:
All Genders
12-80 years
Phase:
PHASE2
Brief Summary
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange (TPE) alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome (CRS...
Detailed Description
A virally mediated pandemic of 2020 is linked to a novel Beta Coronavirus (COVID-19) sharing subgenus classification with the severe acute respiratory syndrome (SARS) virus. The predominant modes of t...
Eligibility Criteria
Inclusion
- Patients positive for COVID-19 by polymerase chain reaction (PCR) assay or alternative accepted methodology
- PENN class 2,3,4 CRS
- Respiratory insufficiency with supplemental oxygen to maintain O2 sat greater than 89%
- Clinically positive imaging by chest x-ray (CXR) or CT scan with evidence of bilateral pulmonary infiltrates, ground glass opacification or other pattern of consolidation felt likely to be linked to COVID infection or complication thereof
- Age 12-80 years of age
Exclusion
- Pregnancy
- Breast feeding
- Class 3-4 New York Heart Association (NYHA) heart failure
- Current use of synthetic disease modifying anti-rheumatic drugs (DMARDS) or IL-6 inhibitors or other immunosuppressive therapies outside of number five below
- Current use of chronic corticosteroids if in excess of prednisone 10mg per day or equivalent
- Suspected or confirmed clinically significant bacterial infection
- History of tuberculosis (TB)
- History of HIV
- History of irritable bowel disease (IBD)
- JAK inhibitor use within last 30 days
- Creatinine clearance less than 15 ml / min
- Absolute neutrophil count \< 1000
- Platelet count \< 50,000
- Clinical assessment that the trial could pose unacceptable risk by study participation
- Current enrollment on another investigational protocol for COVID-19 induced CRS
- Stage 4 obstructive lung disease with chronic hypoxic respiratory failure requiring supplemental O2 at baseline, or interstitial lung disease (ILD) with chronic hypoxic respiratory failure requiring supplemental O2 at baseline
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04374149
Start Date
April 30 2020
End Date
December 1 2020
Last Update
December 2 2021
Active Locations (1)
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1
Prisma Health
Greenville, South Carolina, United States, 29605