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Trial - NCT04342182


Column Value
Trial registration number NCT04342182
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04342182

First author
Last imported at : Nov. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Bart Rijnders, MD, PhD

Contact
Last imported at : Nov. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

b.rijnders@erasmusmc.nl

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-10

Recruitment status
Last imported at : April 2, 2022, 4 p.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients with pcr confirmed covid disease - admitted to the hospital - the most recent pcr positive sample is <96hrs old - written informed consent by patient or legal patient representative - age at least 18 years

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- participation in another intervention trial on the treatment of covid-19 that falls under the dutch law human research (wmo) and in which individual patients are randomized to different treatment options - known iga deficiency - invasive ventilation for already >96 hours donors: eligibility for plasma donation inclusions criteria: - a history of covid infection that was documented by pcr - known abo-resus(d) blood group - a screening for irregular antibodies with a titer ≤ 1:32 - asymptomatic for at least 14 days - written informed consent regarding the plasmapheresis procedure - tested negative for hiv, hbv, hcv, hev, htlv and syfilis

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Erasmus Medical Center

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Netherlands

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : April 2, 2022, 4 p.m.
Source : ClinicalTrials.gov

86

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first

Notes
Last imported at : Oct. 26, 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/Phase 3

Arms
Last imported at : April 13, 2022, 11:30 p.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"}]