An interventional study of Therapeutic plasma exchange in COVID-19 Pneumonia, COVID-19 Respiratory Infection and Acute Respiratory Failure, sponsored by Novacescu Alexandru. Completed at 1 site in Romania. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Novacescu Alexandru · Not applicable, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Novacescu Alexandru as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Therapeutic plasma exchange
In the control arm, patients will receive standard COVID-19 treatment
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
Also known as: Transfusion of convalescent plasma
Survival
Number of Participants who Survived
Time frame: 30 day period
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
C Reactive Protein (CRP)
Average value of CRP calculated using the values from day 1 and day 7
Time frame: 7 day period
Lactate Dehydrogenase (LDH)
Average value of LDH calculated using the values from day 1 and day 7
Time frame: 7 day period
Ferritin
Average value of ferritin calculated using the values from day 1 and day 7
Time frame: 7 day period
| Milestone | Treatment Arm | Control Arm |
|---|---|---|
| Started | 19 | 19 |
| Completed | 19 | 19 |
| Not completed | 0 | 0 |
Number of Participants who Survived
| Participants | Treatment Arm | Control Arm |
|---|---|---|
| Survival | 9 | 5 |
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
| ratio | Treatment Arm | Control Arm |
|---|---|---|
| P/F Ratio | 141.88 ± 37.19 | 109.61 ± 39.25 |
Average value of CRP calculated using the values from day 1 and day 7
| mg/l | Treatment Arm | Control Arm |
|---|---|---|
| C Reactive Protein (CRP) | 46.17 ± 60.89 | 144.00 ± 115.3 |
Average value of LDH calculated using the values from day 1 and day 7
| U/l | Treatment Arm | Control Arm |
|---|---|---|
| Lactate Dehydrogenase (LDH) | 375.11 ± 127.41 | 548.41 ± 218.03 |
Average value of ferritin calculated using the values from day 1 and day 7
| micrograms/l | Treatment Arm | Control Arm |
|---|---|---|
| Ferritin | 1563.23 ± 1206.05 | 1586.27 ± 1356.42 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 10/19 (52.6%) | 1/19 (5.3%) | 0/19 (0%) |
| Control Arm | 14/19 (73.7%) | 0/19 (0%) | 0/19 (0%) |
| Event | Treatment Arm | Control Arm |
|---|---|---|
| Anaphylactic reactionCardiac disorders | 1/19 | 0/19 |
| Age, Categorical(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 7 | 21 |
| >=65 years | 5 | 12 | 17 |
| Sex: Female, Male(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 13 | 11 | 24 |
| Race (NIH/OMB)(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 19 | 19 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Romania | 19 | 19 | 38 |
| Body mass index(kg/m^2) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 29.75 ± 5.02 | 27.16 ± 6.92 | 28.45 ± 6.10 |
| Comorbidities present(participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Number | 18 | 17 | 35 |
| Symptoms onset to treatment(Days) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 7.68 ± 2.49 | 8.58 ± 2.14 | 8.13 ± 2.33 |
| Acute Physiology and Chronic Health Evaluation (APACHE II)(points) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 5.74 ± 3.16 | 7.58 ± 6.48 | 6.65 ± 5.11 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We plan on sharing treatment protocol, demographic data of the study cohort, primary outcomes, secondary outcomes, miscellaneous data, treatment scheme, statystical data
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.