Adults 12 to 80, any sex, with Cytokine Release Syndrome or COVID19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
C-reactive Protein (CRP) Levels at Baseline and Day 14Primary· Baseline and at Day 14
Defined as decreasing the CRP level from baseline to study day 14
CRP Baseline
Group
Value
95% CI
1 - TPE Alone
75.45
41.75 – 147.9
2 - TPE Plus Ruxolitinib
59.8
49.025 – 101.6
CRP Day 14
Group
Value
95% CI
1 - TPE Alone
41.9
17.9 – 156.2
2 - TPE Plus Ruxolitinib
38.7
8.6 – 103.8
Cytokine Levels at Baseline and Day 14Primary· Baseline and at Day 14
Defined as decreasing the interleukin (IL) IL-6 and IL-10 load and the tumor necrosis factor (TNF) load from baseline to study day 14
IL-6 Baseline
Group
Value
95% CI
1 - TPE Alone
41.32
9.79 – 67.25
2 - TPE Plus Ruxolitinib
14.22
7.02 – 42.07
IL-6 Day 14
Group
Value
95% CI
1 - TPE Alone
14.8
5.8 – 53.88
2 - TPE Plus Ruxolitinib
18.72
7.4 – 31.92
IL-10 Baseline
Group
Value
95% CI
1 - TPE Alone
8.06
6.22 – 20.81
2 - TPE Plus Ruxolitinib
5.6
4.67 – 6.84
IL-10 Day 14
Group
Value
95% CI
1 - TPE Alone
2
0.56 – 3.16
2 - TPE Plus Ruxolitinib
3.16
2.64 – 3.2
TNF Baseline
Group
Value
95% CI
1 - TPE Alone
10.66
7.38 – 11.3
2 - TPE Plus Ruxolitinib
7.06
5.02 – 10.5
TNF Day 14
Group
Value
95% CI
1 - TPE Alone
9.96
9.28 – 13.64
2 - TPE Plus Ruxolitinib
7
5.32 – 7.56
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data collected from date of consent through study day 28.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04485169 — Therapeutic Plasma Exchange for Coronavirus Disease-2019 Triggered Cytokine Release Storm;
· NA
· completed
Other recruiting trials for Cytokine Release Syndrome
Currently open trials in the same condition.
NCT07169487 — Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
· Phase 1
· recruiting
NCT06447376 — Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
· Phase 1
· recruiting
NCT04975555 — Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associ
· Phase 2
· active not recruiting
Other Prisma Health-Upstate trials
Trials by the same sponsor.
NCT07202039 — Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
· NA
· not yet recruiting
NCT07375212 — VAPorized Administration of Bumetanide for Outpatient Relief in Heart Failure
· Phase 4
· withdrawn
NCT06874413 — Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Vent
· NA
· enrolling by invitation
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prisma Health-Upstate
Last refreshed: 2 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04374149.