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

Part of paid clinical trials in Greenville, South Carolina.

Sponsor
Prisma Health-Upstate
Study ID
NCT04374149
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Therapeutic Plasma Exchange — PROCEDURE
    TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy
  • Ruxolitinib — DRUG
    TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days.

Study Details

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.

Key Dates

Start date
Apr 30, 2020
Status verified
Nov 2021
Primary completion
Sep 30, 2020
Completion
Dec 1, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 - TPE Alone
    TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy
  • Experimental: 2 - TPE Plus Ruxolitinib
    TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or fresh frozen plasma (FFP) replacement if underlying coagulopathy combined with ruxolitinib 5mg po twice daily (BID) beginning day prior to first TPE and continuing BID for total of 14 days.

Primary Outcome Measure

C-reactive Protein (CRP) Levels at Baseline and Day 14 [ Time Frame: Baseline and at Day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Prisma HealthGreenvilleSouth Carolina29605-

Find similar trials in Greenville, SC

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Prisma Health· Greenville, SC

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