NCT04613986

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

November 2, 2020

Last Update Submit

April 27, 2021

Conditions

Severe Covid-19

Outcome Measures

Primary Outcomes (1)

  • relative ADAMTS13 deficiency

    ADAMTS13 / VWF:Ag

    day 1 to 7

Study Arms (2)

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)

Device: therapeutic plasmaexchnage

Interventions

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)

Treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 3, 2020

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

April 29, 2021

Record last verified: 2021-04