Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol will evaluate the efficacy of Therapeutic Plasma Exchange alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome. It is hypothesized that dual intervention of acute apheretic depletion of cytokines and concomitant suppression of production will produce superior amelioration of the cytokine load and to help to prevent cytokine load rebound. This protocol is envisioned as a pilot study (n=20) for hypothesis generation for future investigation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prisma Health-Upstate

Criteria

Inclusion Criteria:

1. Patients positive for COVID-19 by PCR or alternative accepted methodology

2. PENN class 2,3,4 CRS10

3. Respiratory insufficiency with supplemental oxygen to maintain O2 sat greater than 89%

4. Clinically positive imaging by 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

5. Age 12-80 years of age

Exclusion Criteria:

1. Pregnancy

2. Breast feeding

3. Class 3-4 NYHA heart failure

4. Current use of synthetic disease modifying anti-rheumatic drugs (DMARDS) or IL-6 inhibitors or other immunosuppressive therapies outside of number five below

5. Current use of chronic corticosteroids if in excess of prednisone 10mg per day or equivalent

6. Suspected or confirmed clinically significant bacterial infection

7. History of TB

8. History of HIV

9. History of IBD

10. JAK inhibitor use within last 30 days

11. Creatinine clearance less than 15 ml / min

12. Absolute neutrophil count < 1000

13. Platelet count < 50,000

14. Clinical assessment that the trial could pose unacceptable risk by study participation

15. Current enrollment on another investigational protocol for COVID-19 induced CRS

16. Stage 4 obstructive lung disease with chronic hypoxic respiratory failure requiring supplemental O2 at baseline, or ILD with chronic hypoxic respiratory failure requiring supplemental O2 at baseline