Trial Outcomes & Findings for Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients (NCT NCT04973488)
NCT ID: NCT04973488
Last Updated: 2024-08-26
Results Overview
Number of Participants who Survived
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
30 day period
Results posted on
2024-08-26
Participant Flow
All patients included in the study were adults (\>18 years) who presented with acute respiratory failure and ARDS, had positive reverse transcriptase-polymerase chain reaction (RT-PCR) test results for SARS-CoV-2 virus and presented with clinical and/or radiological signs of COVID-19 pneumonia upon hospital admission. Exclusion criteria were represented by any of the following: Pregnancy, patients with suspected or confirmed pulmonary embolisms and patients with terminal disease.
Participant milestones
| Measure |
Treatment Arm
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=19 Participants
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 Participants
In the control arm, patients will receive standard COVID-19 treatment
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Body mass index
|
29.75 kg/m^2
STANDARD_DEVIATION 5.02 • n=99 Participants
|
27.16 kg/m^2
STANDARD_DEVIATION 6.92 • n=107 Participants
|
28.45 kg/m^2
STANDARD_DEVIATION 6.10 • n=206 Participants
|
|
Comorbidities present
|
18 participants
n=99 Participants
|
17 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Symptoms onset to treatment
|
7.68 Days
STANDARD_DEVIATION 2.49 • n=99 Participants
|
8.58 Days
STANDARD_DEVIATION 2.14 • n=107 Participants
|
8.13 Days
STANDARD_DEVIATION 2.33 • n=206 Participants
|
|
Acute Physiology and Chronic Health Evaluation (APACHE II)
|
5.74 points
STANDARD_DEVIATION 3.16 • n=99 Participants
|
7.58 points
STANDARD_DEVIATION 6.48 • n=107 Participants
|
6.65 points
STANDARD_DEVIATION 5.11 • n=206 Participants
|
|
Severe form of COVID-19
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Critical form of COVID-19
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 day periodNumber of Participants who Survived
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 Participants
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
Survival
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 7 day periodAverage Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio - P/F ratio calculated between the values from day 1 and day 7
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 Participants
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
P/F Ratio
|
141.88 ratio
Standard Deviation 37.19
|
109.61 ratio
Standard Deviation 39.25
|
SECONDARY outcome
Timeframe: 7 day periodAverage value of CRP calculated using the values from day 1 and day 7
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 Participants
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
C Reactive Protein (CRP)
|
46.17 mg/l
Standard Deviation 60.89
|
144.00 mg/l
Standard Deviation 115.3
|
SECONDARY outcome
Timeframe: 7 day periodAverage value of LDH calculated using the values from day 1 and day 7
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 Participants
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
Lactate Dehydrogenase (LDH)
|
375.11 U/l
Standard Deviation 127.41
|
548.41 U/l
Standard Deviation 218.03
|
SECONDARY outcome
Timeframe: 7 day periodAverage value of ferritin calculated using the values from day 1 and day 7
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 Participants
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
Ferritin
|
1563.23 micrograms/l
Standard Deviation 1206.05
|
1586.27 micrograms/l
Standard Deviation 1356.42
|
Adverse Events
Treatment Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 10 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Treatment Arm
n=19 participants at risk
In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused
Therapeutic plasma exchange: The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
|
Control Arm
n=19 participants at risk
In the control arm, patients will receive standard COVID-19 treatment
|
|---|---|---|
|
Cardiac disorders
Anaphylactic reaction
|
5.3%
1/19 • Number of events 1 • 1 month
Data regarding adverse event collection was obtained by the continuous monitoring of vital signs specific for the intensive care unit. During the treatment proposed in the intervention arm of this trial, a physician was supervising the vital signs of the patient to immediately stop the treatment in the event of an adverse event.
|
0.00%
0/19 • 1 month
Data regarding adverse event collection was obtained by the continuous monitoring of vital signs specific for the intensive care unit. During the treatment proposed in the intervention arm of this trial, a physician was supervising the vital signs of the patient to immediately stop the treatment in the event of an adverse event.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Novacescu Alexandru
University of Medicine and Pharmacy "Victor Babes" Timisoara
Phone: +40745064844
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place