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Trial - NCT04751643


Column Value
Trial registration number NCT04751643
Full text link
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04751643

First author
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Olivier HEQUET, MD, PhD

Contact
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

olivier.hequet@efs.sante.fr

Registration date
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-12

Recruitment status
Last imported at : April 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

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

multi-center

Study aim
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - age > 18 years - hospitalized for covid-19 confirmed by reverse transcriptase-polymerase chain reaction (rt-pcr) or scanner - patients with pao2/fio2 between 100 and 200 mmhg requiring non invasive ventilation or high flow oxygen - at least two biological results suggesting a cytokine storm or hyperinflammatory condition state among : c-reactive protéine (crp)>50mg/l, procalcitonin (pct)>1µg/l, fibrinogen>5g/l, d-dimer >1000ng/ml, ferritin > 800ng/ml during the last 72 hours. - treatment with corticosteroids (at least 2 intakes of dexamethasone 6 mg or equivalent with another form of corticosteroids) - patient affiliated to a social security or similar scheme - information and written consent from the patient or if not possible from a confident person

Exclusion criteria
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- ventilated intubated patients - patient with advanced cancer and without curative possibility - bacterial or viral (hiv) infection explaining the worsening (the main reason) - body mass index > 40 - impossibility to put a central venous catheter according to investigator's judgement - severe hemodynamic instability with mean arterial pressure < 65 mmhg (whatever the noradrenaline dosage used) - immunoglobulin a (iga) deficiency with anti-iga antibodies - inclusion in another study that could interact with the covidep study (investigator's judgement) - patient under legal protection measure - pregnant or breastfeeding women - in case of allergy to amotosalen (psoralens) or ai-ffp (amotosalen inactivated fresh frozen plasma) , use se-ffp (secured fresh frozen plasma)

Number of arms
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Hospices Civils de Lyon

Inclusion age min
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

132

primary outcome
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Use of intubation and invasive ventilation (IV) between Day 0 (Inclusion Visit) and Day 10

Notes
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Not reported

Arms
Last imported at : Feb. 16, 2021, 12:31 a.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"}]