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

NCT ID: NCT04613986

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-07-31

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).

Conditions

Severe Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard

Standard of care according to our current in house SOP

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5)

Group Type: EXPERIMENTAL

therapeutic plasmaexchnage

Intervention Type: DEVICE

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)

Interventions

therapeutic 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)

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SD01

Identifier Type: -

Identifier Source: org_study_id