Trial Outcomes & Findings for Study of Plasma Exchange in Severe COVID-19 (NCT NCT04623255)

Last Updated: 2024-06-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

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).

Results posted on

2024-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	STANDARD OF CARE Standard patient care for severe COVID-19	Plasma Exchange Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange
Overall Study STARTED	11	12
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Plasma Exchange in Severe COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STANDARD OF CARE n=11 Participants Standard patient care for severe COVID-19	Plasma Exchange n=12 Participants Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Population: Note: 23 patients with severe COVID-19 were randomised. One patient withdrew from the study 1 day after randomisation and their data has been excluded from the analysis. There were no follow-up data for a further two participants for this endpoint (1 from each arm) and hence they were omitted from this analysis, so data from a total of 20 participants was analysed.

Outcome measures

Outcome measures
Measure	STANDARD OF CARE n=10 Participants Standard patient care for severe COVID-19	Plasma Exchange n=10 Participants Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange
Number of Participants With Inflammatory Marker Reduction of at Least 50% at Any Efficacy Time Point	5 Participants	8 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	STANDARD OF CARE n=10 Participants Standard patient care for severe COVID-19	Plasma Exchange n=10 Participants Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange
Change in Inflammatory Marker-CRP	8 Participants	7 Participants

PRIMARY outcome

Timeframe: 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).

Population: Note: 23 patients with severe COVID-19 were randomised. One patient withdrew from the study 1 day after randomisation and their data has been excluded from the analysis. There were no follow-up data for a further three participants for this endpoint (1 from standard of care arm and 2 from plasma exchange arm) and hence they were omitted from this analysis, so data from a total of 19 participants was analysed.

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.

Outcome measures

Outcome measures
Measure	STANDARD OF CARE n=10 Participants Standard patient care for severe COVID-19	Plasma Exchange n=9 Participants Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange
Change in Inflammatory Marker-D Dimer	4 Participants	6 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	STANDARD OF CARE n=10 Participants Standard patient care for severe COVID-19	Plasma Exchange n=10 Participants Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange
Change in Inflammatory Marker-LDH	5 Participants	6 Participants

Adverse Events

STANDARD OF CARE

Serious events: 4 serious events

Other events: 11 other events

Deaths: 1 deaths

Plasma Exchange

Serious events: 6 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Prof Marie Scully

University College London

Phone: + 44 (0)20 3447 9884

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	STANDARD OF CARE n=11 participants at risk Standard patient care for severe COVID-19	Plasma Exchange n=11 participants at risk Standard patient care for severe COVID-19 with. plasma exchange daily for 5 days x 3 courses as required OCTAPLAS: plasma exchange
Investigations Blood pressure decreased	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 2 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Investigations Body temperature increased	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Investigations Heart rate increased	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Investigations Oxygen saturation decreased	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	18.2% 2/11 • Number of events 5 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Cardiac disorders Pericarditis	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Cardiac disorders Cardiac arrest	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Cardiac disorders Atrial fibrillation	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Cardiac disorders Acute myocardial infarction	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Surgical and medical procedures Oxygen therapy	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	18.2% 2/11 • Number of events 2 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Surgical and medical procedures Drug therapy	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Surgical and medical procedures Endotracheal intubation	18.2% 2/11 • Number of events 2 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	36.4% 4/11 • Number of events 4 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Surgical and medical procedures Lung assist device therapy	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
General disorders Multiple organ dysfunction syndrome	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Hepatobiliary disorders Hepatitis	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Respiratory, thoracic and mediastinal disorders Lung disorder	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Renal and urinary disorders Renal impairment	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Infections and infestations Bacterial infection	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Infections and infestations Central nervous system infection	9.1% 1/11 • Number of events 1 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.
Infections and infestations Sepsis	0.00% 0/11 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.	9.1% 1/11 • Number of events 2 • All adverse events will be recorded from consent to the end of trial (day 28 after randomisation). Serious Adverse Events associated with COVID-19 infection were not reported to Sponsor for this trial, however they were recorded in the database and are included in this report.