COVID-19
Conditions
Interventions
Trade Name: OctaplasLG
Product Name: OctaplasLG
Pharmaceutical Form: Solution for infusion
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion 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) b. Raised D Dimers (> 2X ULN) c. 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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) • Pregnancy • Known allergies to Octaplas or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare reduction in inflammatory markers between PEX and a control group in patients with severe COVID;Secondary Objective: Among patients requiring CPAP/ NIV at treatment onset, the ability to prevent deterioration to requiring mechanical ventilation Reduction in clinical thrombotic events documented by DVT, or arterial thrombus (cardiac, neurological and peripheral vascular) Reduction in the inflammatory-thrombotic response by monitoring VWFAg/ADAMTS 13 activity ratio by 50% from baseline pre PEX to the end of treatment. Stable cardiac function throughout period of PEX based on echocardiogram/troponin/BNP measurements 28 day mortality ;Primary end point(s): To compare the reduction in inflammatory markers between Plasma Exchange (PEX) and the control group in patients with severe COVID;Timepoint(s) of evaluation of this end point: These parameters will be analysed at the beginning of the trial to assess eligibility and at the end when all the data has been collected | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Primary: To compare the reduction in inflammatory markers between Plasma Exchange (PEX) and the control group in patients with severe COVID Secondary: To compare rates of mechanical ventilation between Plasma Exchange (PEX) and control groups in patients with severe COVID requiring CPAP/ NIV at treatment onset To compare rates of clinical thrombotic events either venous (deep vein thrombosis DVT or pulmonary embolism PE) or arterial thrombus (cardiac, neurological and peripheral vascular) between Plasma Exchange (PEX) and control groups in patients with severe COVID To compare reduction in the inflammatory-thrombotic response by monitoring von Willebrand factor VWFA antigen/ADAMTS 13 activity ratio between Plasma Exchange (PEX) and control groups in patients with severe COVID To compare the stability of cardiac function based on echocardiogram/troponin/BNP measurements cardiac function between Plasma Exchange (PEX) and control groups in patients with severe COVID To compare incidence of acute kidney injury as defined by KDIGO criteria between Plasma Exchange (PEX) and control groups in patients with severe COVID To compare mortality at day 28 between the PEX and control groups ;Timepoint(s) of evaluation of this end point: These parameters will be analysed at the beginning of the trial to assess eligibility and at the end when all the data has been collected | — |
Countries
United Kingdom
Outcome results
None listed