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Trial - NCT04623255


Column Value
Trial registration number NCT04623255
Full text link
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04623255

First author
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Marie Scully, MD

Contact
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

m.scully@ucl.ac.uk

Registration date
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-11-10

Recruitment status
Last imported at : Nov. 7, 2022, noon
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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: raised ldh (> 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
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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) - known allergies to octaplas or excipients - females who are pregnant

Number of arms
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University College, London

Inclusion age min
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United Kingdom

Type of patients
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

20

primary outcome
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Change in Inflammatory Marker-D Dimer;Change in Inflammatory Marker-CRP;Change in Inflammatory Marker-LDH

Notes
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"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"}]