COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002668-29/GB

University College London

Not reported

2020-06-10

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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

2

University College London

18

100

United Kingdom

Severe disease at enrollment

6: Severe disease at enrollment

40

To compare the reduction in inflammatory markers between Plasma Exchange (PEX) and the control group in patients with severe COVID

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1000, "treatment_name": "Plasma exchange", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]