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Trial - NCT04649879


Column Value
Trial registration number NCT04649879
Full text link
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04649879

First author
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Joakim Dillner, MD, PhD

Contact
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

joakim.dillner@ki.se

Registration date
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-02

Recruitment status
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 3, 2020, 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 : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - age greater than or equal to 18 - admitted to a study hospital - active covid-19 defined as symptoms + sars cov-2 identified from upper or lower airway samples and blood - negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential - written informed consent after meeting with a study physician and ability and willingness to complete follow up

Exclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- no matching plasma donor (exact matching in the abo system is required) - unavailability of plasma - estimated glomerular filtration rate <30 (kidney failure stage iii or more) - pregnancy (urinary-hcg) - breast feeding - inability to give informed consent

Number of arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Joakim Dillner

Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Sweden

Type of patients
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

59

primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

COVID-19 related mortality within 28 days

Notes
Last imported at : Dec. 3, 2020, 12:31 a.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 : Dec. 3, 2020, 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"}]