Severe Covid-19PExCoVNCT04613986
Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19
A study testing therapeutic plasmaexchnage in people with Severe Covid-19, run by University of Zurich.
Trial summary
Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC). A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Severe Covid-19
- What is being tested?
- therapeutic plasmaexchnage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jul 2022
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven SARS-CoV2 infection
- Severe Covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation)
- Evidence of coagulopathy (indicated by D-dimer > 10 mg/L)
- Evidence of systemic inflammation (CRP > 100 mg/L , ferritin > 500 ng/mL)
Who cannot join
- • Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study.
- Extra corporeal membrane oxygenation (ECMO)
About this study
Official title: Randomized, Prospective, Open-label, Controlled Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat the Systemic Inflammatory Response Against SARS-CoV2 and the Associated Coagulopathy
Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC).
A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).
- Conditions
- Severe Covid-19
- Being tested
- therapeutic plasmaexchnage
- 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 plasmaexchnageDevice
established method to exchange plasma (in order to remove injurious disease mediators, e.g. antibodies) or to replace consumed factors (e.g. vWF cleaving proteases)
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard of care according to our current in house SOP |
| Treatment | Experimental | Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5) Receives: Device: therapeutic plasmaexchnage |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative ADAMTS13 deficiency
ADAMTS13 / VWF:Ag
Measured: day 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study startJun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Covid-19Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613986
- Sponsor's protocol ID
- SD01
- Acronym
- PExCoV
- Status last verified
- Apr 2021
- First submitted
- 2 Nov 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Open-label, Controlled Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat the Systemic Inflammatory Response Against SARS-CoV2 and the Associated Coagulopathy
- ClinicalTrials.gov ID
- NCT04613986
- Acronym / sponsor ID
- PExCoV / SD01
- Conditions
- Severe Covid-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 3 Nov 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.
Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC).
A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard of care according to our current in house SOP |
| Treatment | Experimental | Device: therapeutic plasmaexchnageStandard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proven SARS-CoV2 infection
- Severe Covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation)
- Evidence of coagulopathy (indicated by D-dimer > 10 mg/L)
- Evidence of systemic inflammation (CRP > 100 mg/L , ferritin > 500 ng/mL)
Key exclusion criteria (3 listed)
- • Participation in another study with investigational drug within the 30 days preceding and during the present study,
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 plasmaexchnageestablished method to exchange plasma (in order to remove injurious disease mediators, e.g. antibodies) or to replace consumed factors (e.g. vWF cleaving proteases) | Device | Treatment |
Primary outcome
relative ADAMTS13 deficiency
Time frame: day 1 to 7
ADAMTS13 / VWF:Ag
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic plasmaexchnage in people with Severe Covid-19, run by University of Zurich.
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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
relative ADAMTS13 deficiency (time frame: day 1 to 7). 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 29 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.