Study of Plasma Exchange in Severe COVID-19

NCT04623255 | Completed Phase 2 Results DMC

• 1 other identifier: 132796
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale in severe COVID19 infection is to undertake PEX to aid reduction of the hyperinflammation and reduce the morbidity and mortality to the lungs, but also systemically, such as the heart, kidneys and brain. A feasibility study of PEX therapy has been undertaken and confirmed a reduction in the inflammatory markers, no VTE/arterial events and normalisation of the renal function and cardiac function throughout the period of therapy. As plasma exchange is an intensive treatment modality, blocks of 5 daily PEX will be undertaken. Further blocks of PEX treatment can be initiated as dictated by the clinical and laboratory parameters. Unlike many therapeutic schedules, there is no immunosuppression associated with PEX; indeed, the resulting decrease in inflammatory markers were shown to be associated with an increase and sustained lymphocytes count.

Conditions

COVID19

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Inflammatory Marker Reduction of at Least 50% at Any Efficacy Time Point

  The primary outcome in this study is a binary outcome indicating whether there was a reduction of at least 50% (compared to baseline) in two or more inflammatory markers \[CRP, LDH, D-Dimer\] during a"comparable duration of treatment" with either PEX or Standard of Care after study initiation.

  The inflammatory markers recorded in this study are C reactive protein (CRP), lactate dehydrogenase(LDH) and D-Dimer, and we consider whether there is a reduction during the designated follow-up period (i.e. follow-up days 6, 7, 14, 21 and 28).

• Change in Inflammatory Marker-CRP

  To compare the change in inflammatory marker CRP with Plasma Exchange and control groups in patients with severe COVID-19. Measured as number of participants who experienced a reduction of 50% at any follow-up time point.

  We consider whether there is a reduction in inflammatory marker CRP during the designated follow-up period (i.e. follow-up days 6, 7, 14, 21 and 28).

• Change in Inflammatory Marker-D Dimer

  To compare the change in inflammatory marker D-dimer with Plasma Exchange and control groups in patients with severe COVID-19. Measured as number of participants who experienced a reduction of 50% at any follow-up time point.

  We consider whether there is a reduction in inflammatory marker D-dimer during the designated follow-up period (i.e. follow-up days 6, 7, 14, 21 and 28).

• Change in Inflammatory Marker-LDH

  To compare the change in inflammatory marker LDH with Plasma Exchange and control groups in patients with severe COVID-19. Measured as number of participants who experienced a reduction of 50% at any follow-up time point.

  We consider whether there is a reduction in inflammatory marker LDH during the designated follow-up period (i.e. follow-up days 6, 7, 14, 21 and 28).

Study Arms (2)

STANDARD OF CARE

NO INTERVENTION

Standard patient care for severe COVID-19

Plasma exchange

ACTIVE COMPARATOR

Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required

Drug: OCTAPLAS

Interventions

OCTAPLAS DRUG

plasma exchange

Also known as: plasma exchange

Plasma exchange

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• Proven COVID-19/high clinical suspicion of COVID-19
• Hypoxia/respiratory compromise defined as requiring respiratory support of \>2L/min of oxygen by nasal cannulae to maintain SpO2\<96%.
• Raised inflammatory parameters: at least 2 of the following:
• Raised LDH (\> 2 x ULN)
• Raised D Dimers (\> 2X ULN)
• Raised CRP (\>2X ULN)
• Females of childbearing potential have a negative pregnancy test within 7 days prior to being randomised. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal

You may not qualify if:

• Significant co-morbid illness with treatment escalation limited to CPAP
• Active bleeding
• PF ratio \< 100 on mechanical ventilation OR noradrenaline requirement \> 0.5mcg/kg/min to maintain MAP \> 65mmHg (suggests futility)
• Known allergies to Octaplas or excipients
• Females who are pregnant

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

• Arulkumaran N, Thomas M, Stubbs M, Prasanna N, Subhan M, Singh D, Ambler G, Waller A, Singer M, Brealey D, Scully M. A randomised controlled trial of plasma exchange compared to standard of care in the treatment of severe COVID-19 infection (COVIPLEX). Sci Rep. 2024 Jul 23;14(1):16876. doi: 10.1038/s41598-024-67028-3.

  PMID: 39043682 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Prof Marie Scully
• Organization: University College London

m.scully@ucl.ac.uk

+ 44 (0)20 3447 9884

Study Officials

• Marie Scully, MD

  UCLH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: November 10, 2020
• Study Start: October 16, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)