COVID-19COVID-ECPNCT05882331
Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19
A study testing Extracorporeal photopheresis in people with COVID-19, run by Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases at 1 site in Hungary.
Trial summary
Optimal approach for adult patients hospitalized with severe and critical COVID-19 non-responsive to antiviral and immunomodulatory drugs is not well established. The study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ECP) in this setting. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Extracorporeal photopheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2021to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe or critical COVID-19,
- clinical and biochemical non-response for >5 consecutive days, despite remdesivir, dexamethasone and immunomodulatory therapies (tocilizumab, baricitinib or ruxolitinib), with or without COVID-19 reconvalescent plasmatherapy, in absence of other causes.
Who cannot join
- pregnancy or breastfeeding,
- allergy or contraindications to 8-methoxypsoralen,
- pre-COVID-19 ECP,
- written informed consent was not obtainable.
- Clinical non-response is defined when ≥2 of the following are met, compared to baseline:
- persistent fever (non-contact tympanal measurement of >38.0°C) for ≥48 hours, despite antipyretics,
Show all 16Show fewer
- persistent or failing COVID-19 severity, according to World Health Organization criteria, by ≥1 stratum after ≥48 hours,
- persistent or failing partial arterial oxygen tension (PaO2) / inspired oxygen fraction (FiO2), by ≥10% after ≥48 hours, despite respiratory support,
- radiological progression by infiltrate extension on chest computed tomography (CT), by ≥10% after ≥48 hours,
- novel requirement of invasive mechanical ventilation, as deemed necessary by an intensive care unit (ICU) team.
- Biochemical non-response is defined when ≥2 of the following analytes show persistent or increasing levels by ≥20% after ≥48 hours, compared to baseline:
- serum lactate dehydrogenase (LDH),
- serum C-reactive protein (CRP),
- serum ferritin
- plasma interleukin-6 (IL-6),
- D-dimer.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
South Pest Central Hospital, National Institute of Haematology and Infectious Diseases
Budapest, 1097
About this study
Official title: Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19 Non-responsive to Remdesivir, Dexamethasone and Pharmacological Immunomodulation: an Investigational Study
Optimal approach for adult patients hospitalized with severe and critical COVID-19 non-responsive to antiviral and immunomodulatory drugs is not well established. The study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ECP) in this setting.
Read the detailed description
A prospective, single-center investigational study is olanned to be performed at a tertiary referral center for COVID-19. Patients with COVID-19 are screened, and severe or critical COVID-19 cases fulfilling pre-defined clinical and biochemical criteria of non-response for >5 days despite remdesivir, dexamethasone and immunomodulation (tocilizumab, baricitinib, ruxolitinib) are consecutively enrolled. After inclusion, two ECP sessions on two consecutive days per week for 2 weeks are applied. Patients are followed up per protocol from study inclusion, and clinical, virological and radiological outcomes are assessed at end-of-treatment (EOT)+28 days.
- Conditions
- COVID-19
- Being tested
- Extracorporeal photopheresis
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal photopheresisProcedure or surgery
Also called Therakos Cellex system
ECP is initiated on study inclusion day by Therakos Cellex system, according to manufacturers' instructions. Each patient receives two ECP cycles for 2 weeks, each consisting of two sessions on consecutive days per week (alltogether four sessions), through a peripheral or central venous route. Cycles 1 and 2 are separated by 5 consecutive days. One ECP session takes ~3 hours, and is separated into 4 phases. On priming, the system performes a series of calibrations to ensure proper operation. During collection, 1500 ml of whole blood is processed to collect a concentrated buffy coat containing white blood cells, while other cells and plasma are reinfused. During the photoactive phase, a prescribed dose of 8-methoxypsoralen is added to the buffy coat, which is then circulated through ultraviolet-A photoactivation. During reinfusion phase, treated cells are automatically reinfused to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal photopheresis arm | Experimental | Patients will receive extracorporeal photopheresis on this arm, in conjucntion to standard COVID-19 treatments (remdesivir, dexamethasone, IL-6- and/or JAK-inhibition). Receives: Procedure: Extracorporeal photopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Clinical outcomes are all-cause death, invasive mechanical ventilation and ICU admittance requirement.
Measured: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Virological outcomes
Virological outcomes are respiratory and blood SARS-CoV-2 RT-PCR positivity.
Measured: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Radiological outcomes
Radiological outcomes are radiological progression/regression or fixed infiltration on chest CT scan.
Measured: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jan 2021
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- ECP is initiated on study inclusion day by Therakos Cellex system, according to manufacturers' instructions. Each patient receives two ECP cycles for 2 weeks, each consisting of two sessions on consecutive days per week (alltogether four sessions), through a peripheral or central venous route. Cycles 1 and 2 are separated by 5 consecutive days. One ECP session takes \~3 hours, and is separated into 4 phases. On priming, the system performes a series of calibrations to ensure proper operation. During collection, 1500 ml of whole blood is processed to collect a concentrated buffy coat containing white blood cells, while other cells and plasma are reinfused. During the photoactive phase, a prescribed dose of 8-methoxypsoralen is added to the buffy coat, which is then circulated through ultraviolet-A photoactivation. During reinfusion phase, treated cells are automatically reinfused to the patient.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bálint Gergely Szabó, Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases
- Investigators
- Istvan Valyi-Nagy, Prof. Dr., Study director, South Pest Central Hospital, National Institute of Hematology and Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882331
- Sponsor's protocol ID
- COVID-ECP
- Acronym
- COVID-ECP
- Status last verified
- Aug 2024
- First submitted
- 25 May 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized, individial patient data will be available to other researchers upon reasonbla request from the principal infestigator.
Publications
Szabo BG, Remenyi P, Tasnady S, Korozs D, Gopcsa L, Reti M, Varkonyi A, Sinko J, Lakatos B, Szlavik J, Beko G, Bobek I, Valyi-Nagy I. Extracorporeal Photopheresis as a Possible Therapeutic Approach for Adults with Severe and Critical COVID-19 Non-Responsive to Standard Treatment: A Pilot Investigational Study. J Clin Med. 2023 Jul 29;12(15):5000. doi: 10.3390/jcm12155000.
PubMed 37568402
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19 Non-responsive to Remdesivir, Dexamethasone and Pharmacological Immunomodulation: an Investigational Study
- ClinicalTrials.gov ID
- NCT05882331
- Acronym / sponsor ID
- COVID-ECP / COVID-ECP
- Conditions
- COVID-19
- Keywords
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Del-Pest Central Hospital - National Institute of Hematology and Infectious DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimal approach for adult patients hospitalized with severe and critical COVID-19 non-responsive to antiviral and immunomodulatory drugs is not well established. The study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ECP) in this setting.
Detailed description
A prospective, single-center investigational study is olanned to be performed at a tertiary referral center for COVID-19. Patients with COVID-19 are screened, and severe or critical COVID-19 cases fulfilling pre-defined clinical and biochemical criteria of non-response for >5 days despite remdesivir, dexamethasone and immunomodulation (tocilizumab, baricitinib, ruxolitinib) are consecutively enrolled. After inclusion, two ECP sessions on two consecutive days per week for 2 weeks are applied. Patients are followed up per protocol from study inclusion, and clinical, virological and radiological outcomes are assessed at end-of-treatment (EOT)+28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ECP is initiated on study inclusion day by Therakos Cellex system, according to manufacturers' instructions. Each patient receives two ECP cycles for 2 weeks, each consisting of two sessions on consecutive days per week (alltogether four sessions), through a peripheral or central venous route. Cycles 1 and 2 are separated by 5 consecutive days. One ECP session takes ~3 hours, and is separated into 4 phases. On priming, the system performes a series of calibrations to ensure proper operation. During collection, 1500 ml of whole blood is processed to collect a concentrated buffy coat containing white blood cells, while other cells and plasma are reinfused. During the photoactive phase, a prescribed dose of 8-methoxypsoralen is added to the buffy coat, which is then circulated through ultraviolet-A photoactivation. During reinfusion phase, treated cells are automatically reinfused to the patient.
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal photopheresis arm | Experimental | Procedure: Extracorporeal photopheresisPatients will receive extracorporeal photopheresis on this arm, in conjucntion to standard COVID-19 treatments (remdesivir, dexamethasone, IL-6- and/or JAK-inhibition). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- severe or critical COVID-19,
- clinical and biochemical non-response for >5 consecutive days, despite remdesivir, dexamethasone and immunomodulatory therapies (tocilizumab, baricitinib or ruxolitinib), with or without COVID-19 reconvalescent plasmatherapy, in absence of other causes.
Key exclusion criteria (16 listed)
- pregnancy or breastfeeding,
- allergy or contraindications to 8-methoxypsoralen,
- pre-COVID-19 ECP,
- written informed consent was not obtainable.
- persistent fever (non-contact tympanal measurement of >38.0°C) for ≥48 hours, despite antipyretics,
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 |
|---|---|---|
| Extracorporeal photopheresisAlso: Therakos Cellex systemECP is initiated on study inclusion day by Therakos Cellex system, according to manufacturers' instructions. Each patient receives two ECP cycles for 2 weeks, each consisting of two sessions on consecutive days per week (alltogether four sessions), through a peripheral or central venous route. Cycles 1 and 2 are separated by 5 consecutive days. One ECP session takes ~3 hours, and is separated into 4 phases. On priming, the system performes a series of calibrations to ensure proper operation. During collection, 1500 ml of whole blood is processed to collect a concentrated buffy coat containing white blood cells, while other cells and plasma are reinfused. During the photoactive phase, a prescribed dose of 8-methoxypsoralen is added to the buffy coat, which is then circulated through ultraviolet-A photoactivation. During reinfusion phase, treated cells are automatically reinfused to the patient. | Procedure or surgery | Extracorporeal photopheresis arm |
Primary outcome
Clinical outcomes
Time frame: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Clinical outcomes are all-cause death, invasive mechanical ventilation and ICU admittance requirement.
Virological outcomes
Time frame: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Virological outcomes are respiratory and blood SARS-CoV-2 RT-PCR positivity.
Radiological outcomes
Time frame: All outcomes are assessed at EOT+28 days and compared to data at inclusion.
Radiological outcomes are radiological progression/regression or fixed infiltration on chest CT scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 37568402Szabo BG, Remenyi P, Tasnady S, Korozs D, Gopcsa L, Reti M, Varkonyi A, Sinko J, Lakatos B, Szlavik J, Beko G, Bobek I, Valyi-Nagy I. Extracorporeal Photopheresis as a Possible Therapeutic Approach for Adults with Severe and Critical COVID-19 Non-Responsive to Standard Treatment: A Pilot Investigational Study. J Clin Med. 2023 Jul 29;12(15):5000. doi: 10.3390/jcm12155000.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized, individial patient data will be available to other researchers upon reasonbla request from the principal infestigator.
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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.
Istvan Valyi-Nagy, Prof. Dr. study director
South Pest Central Hospital, National Institute of Hematology and Infectious Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal photopheresis in people with COVID-19, run by Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases at 1 site in Hungary.
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 2 inclusion and 16 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 6 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcomes (time frame: All outcomes are assessed at EOT+28 days and compared to data at inclusion.). The study lists 3 primary outcomes in all. 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 NCT05882331, 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 6 Aug 2024.