Respiratory Failure Clinical Trial
— COVID-PLEXOfficial title:
Plasma Exchange (PLEX) and Convalescent Plasma (CCP) in COVID-19 Patients With Multiorgan Failure - the COVID PLEX+CCP Trial
This Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Confirmed SARS-CoV-2 (COVID-19) requiring intensive care AND - Use of Advanced respiratory support as Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system AND RRT (continuous or intermittent) -OR ECMO Exclusion Criteria: - who have received convalescent plasma for COVID-19, - who have known hypersensitivity to plasma, - who are pregnant, - who the clinical team has decided not to escalate therapy (except that for cardiac arrest; patients who are not for cardio-pulmonary-resuscitation may be enrolled). - Who have received RRT for more than 72 hours - Who have received mechanical ventilation for more than 14 days - We will not exclude patients enrolled in other interventional trials unless the protocols of the two trials collide (e.g. use of CCP by protocol). Co-enrolment agreements will be established with the sponsor/investigator to maintain an updated list of trials approved for co-enrolment ( |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Wladimir Szpirt | Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital, Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alive at Day 90th | The primary outcome is days alive and out of hospital from randomisation to day 90. | 90 days | |
Secondary | Day 8 serious adverse events | Serious adverse events - new episode of septic shock, anaphylactic reaction to CCP, invasive fungal infection, TACO, TRALI. | 8 days | |
Secondary | Day 28 all cause mortality | All-cause mortality at day 28 | 28 days | |
Secondary | Days alive without life support at day 90 | Days alive without life support at day 90 | 90 days |
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