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Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04973488
Enrollment
38
Registered
2021-07-22
Start date
2020-07-25
Completion date
2021-01-10
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Acute Respiratory Failure, COVID-19 Pneumonia, COVID-19 Respiratory Infection

Keywords

Therapeutic Plasma Exchange, Convalescent Plasma

Brief summary

Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.

Detailed description

This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.

Interventions

OTHERTherapeutic 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

Sponsors

University of Medicine and Pharmacy Victor Babes Timisoara
CollaboratorOTHER
Novacescu Alexandru
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Not masked

Intervention model description

Single group, that is divided into two arms

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* positive reverse transcriptase PCR test for COVID 19 * COVID-19 pneumonia * All patients included were adults (\>18 years) * Acute respiratory failure

Exclusion criteria

* pregnant women * patients with suspected or confirmed pulmonary embolism * patients with terminal disease

Design outcomes

Primary

MeasureTime frameDescription
Survival30 day periodNumber of Participants who Survived

Secondary

MeasureTime frameDescription
P/F Ratio7 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
C Reactive Protein (CRP)7 day periodAverage value of CRP calculated using the values from day 1 and day 7
Lactate Dehydrogenase (LDH)7 day periodAverage value of LDH calculated using the values from day 1 and day 7
Ferritin7 day periodAverage value of ferritin calculated using the values from day 1 and day 7

Countries

Romania

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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
19
Control Arm
In the control arm, patients will receive standard COVID-19 treatment
19
Total38

Baseline characteristics

CharacteristicTreatment ArmControl ArmTotal
Acute Physiology and Chronic Health Evaluation (APACHE II)5.74 points
STANDARD_DEVIATION 3.16
7.58 points
STANDARD_DEVIATION 6.48
6.65 points
STANDARD_DEVIATION 5.11
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants12 Participants17 Participants
Age, Categorical
Between 18 and 65 years
14 Participants7 Participants21 Participants
Body mass index29.75 kg/m^2
STANDARD_DEVIATION 5.02
27.16 kg/m^2
STANDARD_DEVIATION 6.92
28.45 kg/m^2
STANDARD_DEVIATION 6.1
Comorbidities present18 participants17 participants35 participants
Critical form of COVID-197 Participants9 Participants16 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
19 Participants19 Participants38 Participants
Region of Enrollment
Romania
19 participants19 participants38 participants
Severe form of COVID-1912 Participants10 Participants22 Participants
Sex: Female, Male
Female
6 Participants8 Participants14 Participants
Sex: Female, Male
Male
13 Participants11 Participants24 Participants
Symptoms onset to treatment7.68 Days
STANDARD_DEVIATION 2.49
8.58 Days
STANDARD_DEVIATION 2.14
8.13 Days
STANDARD_DEVIATION 2.33

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
10 / 1914 / 19
other
Total, other adverse events
0 / 190 / 19
serious
Total, serious adverse events
1 / 190 / 19

Outcome results

Primary

Survival

Number of Participants who Survived

Time frame: 30 day period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Treatment ArmSurvival9 Participants
Control ArmSurvival5 Participants
Secondary

C Reactive Protein (CRP)

Average value of CRP calculated using the values from day 1 and day 7

Time frame: 7 day period

ArmMeasureValue (MEAN)Dispersion
Treatment ArmC Reactive Protein (CRP)46.17 mg/lStandard Deviation 60.89
Control ArmC Reactive Protein (CRP)144.00 mg/lStandard Deviation 115.3
Secondary

Ferritin

Average value of ferritin calculated using the values from day 1 and day 7

Time frame: 7 day period

ArmMeasureValue (MEAN)Dispersion
Treatment ArmFerritin1563.23 micrograms/lStandard Deviation 1206.05
Control ArmFerritin1586.27 micrograms/lStandard Deviation 1356.42
Secondary

Lactate Dehydrogenase (LDH)

Average value of LDH calculated using the values from day 1 and day 7

Time frame: 7 day period

ArmMeasureValue (MEAN)Dispersion
Treatment ArmLactate Dehydrogenase (LDH)375.11 U/lStandard Deviation 127.41
Control ArmLactate Dehydrogenase (LDH)548.41 U/lStandard Deviation 218.03
Secondary

P/F Ratio

Average 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

Time frame: 7 day period

ArmMeasureValue (MEAN)Dispersion
Treatment ArmP/F Ratio141.88 ratioStandard Deviation 37.19
Control ArmP/F Ratio109.61 ratioStandard Deviation 39.25

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026