Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04613986

Acronym

PExCoV

Enrollment

Registered

2020-11-03

Start date

2021-06-30

Completion date

2022-07-31

Last updated

2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Covid-19

Brief 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. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).

Interventions

DEVICEtherapeutic plasmaexchnage

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* • 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)

Design outcomes

Primary

Measure	Time frame	Description
relative ADAMTS13 deficiency	day 1 to 7	ADAMTS13 / VWF:Ag

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026