plasma exchange in severe COVID-19 infectio

Phase 1

• Conditions: COVID-19; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-002668-29-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-10
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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<96%.
•Raised inflammatory parameters: at least 2 of the following:
a.Raised LDH (> 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

• 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)
•Pregnancy
•Known allergies to Octaplas or excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified