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Trial - NCT04748588


Column Value
Trial registration number NCT04748588
Full text link
Last imported at : Feb. 12, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04748588

First author
Last imported at : Dec. 17, 2021, 2 a.m.
Source : ClinicalTrials.gov

Alain Tremblay, MDCM

Contact
Last imported at : Dec. 17, 2021, 2 a.m.
Source : ClinicalTrials.gov

atrembla@ucalgary.ca

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

2021-02-10

Recruitment status
Last imported at : April 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Terminated

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

RCT

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

Randomized

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

Parallel

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

Treatment

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

inclusion criteria: - 18 years of age or older - has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay, in any specimen prior to randomization. - admitted to a participating centre - is nosocomially acquired infection, as defined by all of: - covid19 diagnosis being made on admission day three or later; - admitted for a reason other than covid19; - within 5 days of covid19 diagnosis based on test collection date or initial development of symptoms, which ever was earliest.

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

- plan for palliation within 24 hours - known allergy to study medication or its components (non-medicinal ingredients) - ordinal scale 6 or above - admitted to facility for non-medical reasons including primary psychiatric diagnosis or labour and delivery. - pregnancy or breast feeding - weight less than 40kg

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

3

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

University of Calgary

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

18

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

100

Countries
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Canada

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

Mild/moderate disease at enrollment

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

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : April 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

46

primary outcome
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Proportion of participants requiring mechanical ventilation or not surviving to hospital discharge

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

None

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

Phase 4

Arms
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 179, "treatment_name": "Bamlanivimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]