COVID-19 PneumoniaNCT04973488
Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
A study testing Therapeutic plasma exchange in people with COVID-19 Pneumonia and COVID-19 Respiratory Infection, run by Novacescu Alexandru at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 Pneumonia, COVID-19 Respiratory Infection, Acute Respiratory Failure
- What is being tested?
- Therapeutic plasma exchange
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteRomania
- Study dates
- 25 Jul 2020to 10 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- positive reverse transcriptase PCR test for COVID 19
- COVID-19 pneumonia
- All patients included were adults (>18 years)
- Acute respiratory failure
Who cannot join
- pregnant women
- patients with suspected or confirmed pulmonary embolism
- patients with terminal disease
Trial locations and contacts
1 site in 1 country.
Romania1 site
Municipal Hospital "Dr. Teodor Andrei" Lugoj
Lugoj, Timiș County, 305500
About this study
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia, COVID-19 Respiratory Infection, Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- Being tested
- Therapeutic plasma exchange
- Keywords
- Therapeutic Plasma Exchange, Convalescent Plasma
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchangeOther
Also called Transfusion of convalescent plasma
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | 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 Receives: Other: Therapeutic plasma exchange |
| Control arm | No intervention | In the control arm, patients will receive standard COVID-19 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Number of Participants who Survived
Measured: 30 day period
Secondary outcomes (4)
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
Measured: 7 day period
C Reactive Protein (CRP)
Average value of CRP calculated using the values from day 1 and day 7
Measured: 7 day period
Lactate Dehydrogenase (LDH)
Average value of LDH calculated using the values from day 1 and day 7
Measured: 7 day period
Ferritin
Average value of ferritin calculated using the values from day 1 and day 7
Measured: 7 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start25 Jul 2020
- Primary completion10 Jan 2021
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single group, that is divided into two arms
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novacescu Alexandru
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Responsible party
- Sponsor-investigator, Novacescu Alexandru, University of Medicine and Pharmacy "Victor Babes" Timisoara
- Investigators
- Monica Licker, MD, PhD, Principal investigator, University of Medicine and Pharmacy "Victor Babes" Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973488
- Sponsor's protocol ID
- STUDYTPECVP20
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2021
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan on sharing treatment protocol, demographic data of the study cohort, primary outcomes, secondary outcomes, miscellaneous data, treatment scheme, statystical data
Publications
Novacescu AN, Duma G, Buzzi B, Baditoiu LM, Bedreag O, Papurica M, Sandesc D, Sorescu T, Vlad D, Licker M. Therapeutic plasma exchange followed by convalescent plasma transfusion in severe and critically ill COVID-19 patients: A single centre non-randomized controlled trial. Exp Ther Med. 2022 Jan;23(1):76. doi: 10.3892/etm.2021.10999. Epub 2021 Nov 24.
PubMed 34934447
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04973488
- Acronym / sponsor ID
- STUDYTPECVP20
- Conditions
- COVID-19 Pneumonia, COVID-19 Respiratory Infection, Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- Keywords
- Therapeutic Plasma Exchange, Convalescent Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novacescu AlexandruUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single group, that is divided into two arms
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Other: Therapeutic plasma exchangeIn 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 |
| Control arm | No intervention | –In the control arm, patients will receive standard COVID-19 treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- positive reverse transcriptase PCR test for COVID 19
- COVID-19 pneumonia
- All patients included were adults (>18 years)
- Acute respiratory failure
Key exclusion criteria (3 listed)
- pregnant women
- patients with suspected or confirmed pulmonary embolism
- patients with terminal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic plasma exchangeAlso: Transfusion of convalescent plasmaThe intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19 | Other | Treatment arm |
Primary outcome
Survival
Time frame: 30 day period
Number of Participants who Survived
4 secondary outcomes
P/F Ratio
Time frame: 7 day period
C Reactive Protein (CRP)
Time frame: 7 day period
Lactate Dehydrogenase (LDH)
Time frame: 7 day period
Ferritin
Time frame: 7 day period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34934447Novacescu AN, Duma G, Buzzi B, Baditoiu LM, Bedreag O, Papurica M, Sandesc D, Sorescu T, Vlad D, Licker M. Therapeutic plasma exchange followed by convalescent plasma transfusion in severe and critically ill COVID-19 patients: A single centre non-randomized controlled trial. Exp Ther Med. 2022 Jan;23(1):76. doi: 10.3892/etm.2021.10999. Epub 2021 Nov 24.
- World Health Organization. WHO Coronavirus (COVID-19) Dashboard. Geneva: 2021Link provided by the sponsor.
- Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review. JAMA.2020;324(8):782-793Link provided by the sponsor.
- Lin L, Li TS. \[Interpretation of "Guidelines for the diagnosis and treatment of novel coronavirus (2019-nCoV) infection by the national health commission (Trial Version 5)" \]. Zhonghua Yi Xue Za Zhi. 2020;100(0):E001Link provided by the sponsor.
- The ARDS Definition Task Force\*. Acute respiratory distress syndrome: The Berlin definition. JAMA. 2012;307(23):2526-2533Link provided by the sponsor.
- Franchini M, Liumbruno GM. Convalescent plasma for the treatment of severe COVID-19. Biol Targets Ther. 2021;15:31-38Link provided by the sponsor.
- Li L, Zhang W, Hu Y, et al. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: a randomized clinical trial. JAMA. 2020;324(5):460-470Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan on sharing treatment protocol, demographic data of the study cohort, primary outcomes, secondary outcomes, miscellaneous data, treatment scheme, statystical data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Licker, MD, PhD principal investigator
University of Medicine and Pharmacy "Victor Babes" Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic plasma exchange in people with COVID-19 Pneumonia and COVID-19 Respiratory Infection, run by Novacescu Alexandru at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 30 day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.