Trial Outcomes & Findings for Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS (NCT NCT04374149)
NCT ID: NCT04374149
Last Updated: 2021-12-02
Results Overview
Defined as decreasing the CRP level from baseline to study day 14
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline and at Day 14
Results posted on
2021-12-02
Participant Flow
All participants were hospitalized at the time of enrollment. They were identified and referred by the critical care service physicians.
Eligible patients were consecutively enrolled with the first 10 to cohort 1A and the second 10 to cohort 1B.
Participant milestones
| Measure |
1 - TPE Alone
Therapeutic Plasma Exchange (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
Therapeutic Plasma Exchange: 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
|
2 - TPE Plus Ruxolitinib
Therapeutic Plasma Exchange (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.
Therapeutic Plasma Exchange: 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
Ruxolitinib: 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 twice daily (BID) beginning day prior to first TPE and continuing BID for total of 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS
Baseline characteristics by cohort
| Measure |
1 - TPE Alone
n=10 Participants
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
Therapeutic Plasma Exchange: 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
|
2 - TPE Plus Ruxolitinib
n=10 Participants
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.
Therapeutic Plasma Exchange: 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: 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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Body Mass Index
|
34.4 kg/m2
STANDARD_DEVIATION 10.2 • n=5 Participants
|
36.0 kg/m2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
35.2 kg/m2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Days from COVID positive test to first therapeutic plasma exchange (TPE)
|
4.5 Days
n=5 Participants
|
9 Days
n=7 Participants
|
6.75 Days
n=5 Participants
|
|
ABO Blood Group
A-
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ABO Blood Group
A+
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
ABO Blood Group
B+
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
ABO Blood Group
O+
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Respiratory Status per Penn Class
Penn Class 3
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Respiratory Status per Penn Class
Penn Class 4
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Previous or Concomitant Therapy
Glucocorticoids
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Previous or Concomitant Therapy
Convalescent Plasma
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Previous or Concomitant Therapy
Remdesivir
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comorbidities
Diabetes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Comorbidities
Obesity
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at Day 14Defined as decreasing the CRP level from baseline to study day 14
Outcome measures
| Measure |
1 - TPE Alone
n=10 Participants
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
Therapeutic Plasma Exchange: 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
|
2 - TPE Plus Ruxolitinib
n=10 Participants
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.
Therapeutic Plasma Exchange: 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: 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.
|
|---|---|---|
|
C-reactive Protein (CRP) Levels at Baseline and Day 14
CRP Baseline
|
75.45 mg/L
Interval 41.75 to 147.9
|
59.8 mg/L
Interval 49.025 to 101.6
|
|
C-reactive Protein (CRP) Levels at Baseline and Day 14
CRP Day 14
|
41.9 mg/L
Interval 17.9 to 156.2
|
38.7 mg/L
Interval 8.6 to 103.8
|
PRIMARY outcome
Timeframe: Baseline and at Day 14Defined as decreasing the interleukin (IL) IL-6 and IL-10 load and the tumor necrosis factor (TNF) load from baseline to study day 14
Outcome measures
| Measure |
1 - TPE Alone
n=10 Participants
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
Therapeutic Plasma Exchange: 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
|
2 - TPE Plus Ruxolitinib
n=10 Participants
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.
Therapeutic Plasma Exchange: 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: 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.
|
|---|---|---|
|
Cytokine Levels at Baseline and Day 14
IL-6 Baseline
|
41.32 pg/ml
Interval 9.79 to 67.25
|
14.22 pg/ml
Interval 7.02 to 42.07
|
|
Cytokine Levels at Baseline and Day 14
IL-6 Day 14
|
14.8 pg/ml
Interval 5.8 to 53.88
|
18.72 pg/ml
Interval 7.4 to 31.92
|
|
Cytokine Levels at Baseline and Day 14
IL-10 Baseline
|
8.06 pg/ml
Interval 6.22 to 20.81
|
5.6 pg/ml
Interval 4.67 to 6.84
|
|
Cytokine Levels at Baseline and Day 14
IL-10 Day 14
|
2 pg/ml
Interval 0.56 to 3.16
|
3.16 pg/ml
Interval 2.64 to 3.2
|
|
Cytokine Levels at Baseline and Day 14
TNF Baseline
|
10.66 pg/ml
Interval 7.38 to 11.3
|
7.06 pg/ml
Interval 5.02 to 10.5
|
|
Cytokine Levels at Baseline and Day 14
TNF Day 14
|
9.96 pg/ml
Interval 9.28 to 13.64
|
7 pg/ml
Interval 5.32 to 7.56
|
Adverse Events
1 - TPE Alone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
2 - TPE Plus Ruxolitinib
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
1 - TPE Alone
n=10 participants at risk
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
Therapeutic Plasma Exchange: 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
|
2 - TPE Plus Ruxolitinib
n=10 participants at risk
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.
Therapeutic Plasma Exchange: 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: 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.
|
|---|---|---|
|
Cardiac disorders
myocardial infarction
|
10.0%
1/10 • Number of events 1 • Adverse event data collected from date of consent through study day 28
As this was a hospitalized, critically ill patient population, adverse events in this study were defined as events deemed by the investigators to be related to study treatment (TPE and / or ruxolitinib). Adverse events occurring in greater than 5% of patients were reported. All serious adverse events (SAEs) were collected and reported. Patients were assessed daily by the critical care service study investigators.
|
0.00%
0/10 • Adverse event data collected from date of consent through study day 28
As this was a hospitalized, critically ill patient population, adverse events in this study were defined as events deemed by the investigators to be related to study treatment (TPE and / or ruxolitinib). Adverse events occurring in greater than 5% of patients were reported. All serious adverse events (SAEs) were collected and reported. Patients were assessed daily by the critical care service study investigators.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/10 • Adverse event data collected from date of consent through study day 28
As this was a hospitalized, critically ill patient population, adverse events in this study were defined as events deemed by the investigators to be related to study treatment (TPE and / or ruxolitinib). Adverse events occurring in greater than 5% of patients were reported. All serious adverse events (SAEs) were collected and reported. Patients were assessed daily by the critical care service study investigators.
|
10.0%
1/10 • Number of events 1 • Adverse event data collected from date of consent through study day 28
As this was a hospitalized, critically ill patient population, adverse events in this study were defined as events deemed by the investigators to be related to study treatment (TPE and / or ruxolitinib). Adverse events occurring in greater than 5% of patients were reported. All serious adverse events (SAEs) were collected and reported. Patients were assessed daily by the critical care service study investigators.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julie Martin, Director of Cancer Research
Prisma Health
Phone: (864) 455-3667
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place