Phase 2 N=20 Treatment

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

Cytokine Release Syndrome · COVID19

Bottom Line

View on ClinicalTrials.gov: NCT04374149 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Dec 2021

Primary outcome: Primary: C-reactive Protein (CRP) Levels at Baseline and Day 14 — 75.45; 59.8; 41.9; 38.7 mg/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Therapeutic Plasma Exchange (Procedure); Ruxolitinib (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Prisma Health-Upstate
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY C-reactive Protein (CRP) Levels at Baseline and Day 14	75.45; 59.8; 41.9; 38.7	—
PRIMARY Cytokine Levels at Baseline and Day 14	41.32; 14.22; 14.8; 18.72; 8.06; 5.6	—

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). 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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04374149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.