Phase 2
N=23
Study of Plasma Exchange in Severe COVID-19
COVID19
Bottom Line
View on ClinicalTrials.gov: NCT04623255 ↗Enrolled (actual)
23
Serious AEs
45.5%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With Inflammatory Marker Reduction of at Least 50% at Any Efficacy Time Point — 5; 8 Participants — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OCTAPLAS (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University College, London
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Inflammatory Marker Reduction of at Least 50% at Any Efficacy Time Point |
5; 8 | 0.16 |
| PRIMARY Change in Inflammatory Marker-CRP |
8; 7 | 0.606 |
| PRIMARY Change in Inflammatory Marker-D Dimer |
4; 6 | 0.245 |
| PRIMARY Change in Inflammatory Marker-LDH |
5; 6 | 0.653 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Exclusion Criteria
- Significant co-morbid illness with treatment escalation limited to CPAP
- Active bleeding
- PF ratio 0.5mcg/kg/min to maintain MAP > 65mmHg (suggests futility)
- Known allergies to Octaplas or excipients
- Females who are pregnant
Data sourced from ClinicalTrials.gov (NCT04623255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.