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Trial - NCT04712344


Column Value
Trial registration number NCT04712344
Full text link
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04712344

First author
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mario Schiffer, MD

Contact
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

mario.schiffer@uk-erlangen.de

Registration date
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-15

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

Unknown

Study design
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 17, 2021, 12:31 a.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 : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: male or female subject aged ≥18 years. estimated bmi ≥19kg/m² to ≤40kg/m². florid1 sars-cov-2 infection confirmed by rt-pcr in tracheo-bronchial secretion sample or pharyngeal swab sample. ards with horovitz index <300mmhg. necessity of invasive mechanical ventilation. written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in germany ( subject's assent if obtainable

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

previous exposure to covid-19 convalescent plasma. adverse reaction to plasma proteins in medical history. interval >72h since endotracheal intubation. current or imminent necessity of ecmo treatment. pre-existing copd gold stage 4. chronic congestive heart failure nyha ≥3. pre-existing left ventricular ejection fraction <30%.

Number of arms
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University of Erlangen-Nürnberg Medical School

Inclusion age min
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Germany

Type of patients
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

58

primary outcome
Last imported at : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Change in SOFA score from Baseline Visit

Notes
Last imported at : Jan. 17, 2021, 12:31 a.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 : Jan. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]