Therapeutic Plasma ExchangeRELAXNCT04685655
RescuE pLAsma eXchange in Severe COVID-19
A study testing Therapeutic plasma exchange in people with Therapeutic Plasma Exchange and Covid19, run by Heidelberg University at 3 sites in Germany.
Trial summary
The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Therapeutic Plasma Exchange, Covid19
- What is being tested?
- Therapeutic plasma exchange
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesGermany
- Study dates
- 7 Jan 2020to 30 Apr 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent by the study participant or their legally appointed representative.
- Age ≥ 18 years
- Evidence of acute SARS-CoV-2 infection, confirmed by PCR testing
- Invasive ventilation
- Fever ≥ 38.5°C, confirmed by a total of 3 consecutive measurements or ongoing renal replacement therapy and temperature ≥ 37.5°C
- D-dimers ≥ 2mg/L
- Dexamethasone ≥ 6mg/day or equivalent dose on at least 2 days
Who cannot join
- Age > 85 years
- Pre-existing treatment limitations
- Pregnancy
- Confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain
- ST-segment elevation myocardial infarction (STEMI)
- Participation in an intervention study elsewhere
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69120
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70174
About this study
Official title: RescuE pLAsma eXchange in Severe COVID-19 (RELAX Severe COVID-19)
The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. In addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "Severe Acute Respiratory Syndrome Coronavirus 2" (SARS-CoV-2) infection. Therapeutic plasma exchange ("TPE") is being discussed as a therapeutic alternative in patients with severe, refractory COVID-19. The idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of SARS-CoV-2 infection. In general, TPE is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ARDS of other geneses. Moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of TPE in severe COVID-19 courses with previously lacking treatment options. To further evaluate the therapeutic efficacy of TPE in severe COVID-19, a prospective randomized controlled trial of TPE in severe SARS-CoV-2 infection is being conducted at our center. Patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + TPE).
- Conditions
- Therapeutic Plasma Exchange, Covid19
- Being tested
- Therapeutic plasma exchange
- Keywords
- Plasma exchange, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchangeOther
Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 therapy according to center standard alone | No intervention | Not described |
| Therapeutic plasma exchange and COVID-19 therapy according to center standard | Active comparator | Not described Receives: Other: Therapeutic plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Intention to treat analysis
Measured: 30 days after randomization
Secondary outcomes (9)
Survival
Intention to treat \& per protocol
Measured: 15, 30, 60, 90, 365 days after randomization
Ventilator-free days
Measured: 15, 30, 60, 90 days after randomization
Length of hospital an ICU stay
Measured: through study completion, an average of 1 year
Improvement defined as two points on seven point ordinal WHO scale
Measured: through study completion, an average of 1 year
Reduction of vasopressors after TPE treatments
Measured: through study completion, an average of 1 year
Incidence of acute kidney injury, renal replacement therapy and renal recovery
AKI KDIGO criteria
Measured: 15, 30, 60, 90 days after randomization
Frequency of typical complications associated to therapeutic plasma exchange
Measured: through study completion, an average of 1 year
Reduction of inflammation mediators, (auto-)antibodies, and coagulation-associated molecules and their temporal correlation to TPE
Measured: through study completion, an average of 1 year
D-dimer-dependent assessment of therapeutic efficacy.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 Jan 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Why it stopped: Low numbers of severe COVID-19 cases with current variants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Plasma ExchangeStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Therapeutic plasma exchange in patients with severe COVID 19
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nusshag, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685655
- Sponsor's protocol ID
- S-911/2020
- Acronym
- RELAX
- Status last verified
- Apr 2025
- First submitted
- 23 Dec 2020
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RescuE pLAsma eXchange in Severe COVID-19 (RELAX Severe COVID-19)
- ClinicalTrials.gov ID
- NCT04685655
- Acronym / sponsor ID
- RELAX / S-911/2020
- Conditions
- Therapeutic Plasma Exchange, Covid19
- Keywords
- Plasma exchange, Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low numbers of severe COVID-19 cases with current variants.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 28 Dec 2020 (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.
The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. In addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "Severe Acute Respiratory Syndrome Coronavirus 2" (SARS-CoV-2) infection. Therapeutic plasma exchange ("TPE") is being discussed as a therapeutic alternative in patients with severe, refractory COVID-19. The idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of SARS-CoV-2 infection. In general, TPE is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ARDS of other geneses. Moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of TPE in severe COVID-19 courses with previously lacking treatment options. To further evaluate the therapeutic efficacy of TPE in severe COVID-19, a prospective randomized controlled trial of TPE in severe SARS-CoV-2 infection is being conducted at our center. Patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + TPE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Therapeutic plasma exchange in patients with severe COVID 19
| Arm | Type | Receives |
|---|---|---|
| COVID-19 therapy according to center standard alone | No intervention | – |
| Therapeutic plasma exchange and COVID-19 therapy according to center standard | Active comparator | Other: Therapeutic plasma exchange |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent by the study participant or their legally appointed representative.
- Age ≥ 18 years
- Evidence of acute SARS-CoV-2 infection, confirmed by PCR testing
- Invasive ventilation
- Fever ≥ 38.5°C, confirmed by a total of 3 consecutive measurements or ongoing renal replacement therapy and temperature ≥ 37.5°C
Key exclusion criteria (6 listed)
- Age > 85 years
- Pre-existing treatment limitations
- Pregnancy
- Confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain
- ST-segment elevation myocardial infarction (STEMI)
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 exchangeTreatment with therapeutic plasma exchange. Plasma from healthy donors is used. | Other | Therapeutic plasma exchange and COVID-19 therapy according to center standard |
Primary outcome
Survival
Time frame: 30 days after randomization
Intention to treat analysis
9 secondary outcomes
Survival
Time frame: 15, 30, 60, 90, 365 days after randomization
Ventilator-free days
Time frame: 15, 30, 60, 90 days after randomization
Length of hospital an ICU stay
Time frame: through study completion, an average of 1 year
Improvement defined as two points on seven point ordinal WHO scale
Time frame: through study completion, an average of 1 year
Reduction of vasopressors after TPE treatments
Time frame: through study completion, an average of 1 year
Incidence of acute kidney injury, renal replacement therapy and renal recovery
Time frame: 15, 30, 60, 90 days after randomization
Frequency of typical complications associated to therapeutic plasma exchange
Time frame: through study completion, an average of 1 year
Reduction of inflammation mediators, (auto-)antibodies, and coagulation-associated molecules and their temporal correlation to TPE
Time frame: through study completion, an average of 1 year
D-dimer-dependent assessment of therapeutic efficacy.
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Low numbers of severe COVID-19 cases with current variants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided. On request
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Therapeutic Plasma Exchange and Covid19, run by Heidelberg University at 3 sites in Germany.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 was stopped early (reason given: Low numbers of severe COVID-19 cases with current variants.). Results are not available in the source record.
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 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025.