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Trial - NCT04606563


Column Value
Trial registration number NCT04606563
Full text link
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

James A Russell

Contact
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-28

Recruitment status
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 29, 2020, 11:31 p.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 : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

inclusion criteria: hospitalized must be first admission of covid-19, not re-admission primary reason for hospitalization or prolonged hospitalization is because of acute covid-19 diagnosis adults 18 years of age or greater laboratory-proven covid-19 within 14 days prior to hospital admission

Exclusion criteria
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

hypotension (sap < 100 mmhg or dap < 50 mmhg or map < 65 mmhg) hyperkalemia (> 5.5 mmol/l) acute kidney injury (urine output < 0.5 ml/kg/hr and new creatinine > 200 mmol/l, or increase > 100 mmol/l, or gfr < 30 ml/min) use of aliskiren in patients with diabetes mellitus (type 1 or type 2) or moderate-severe renal impairment (gfr less than 60ml/min) use of arb/acei within 7 days of presentation pregnant or breastfeeding have a known allergy to arbs or any component of the drug product have written legal document to withhold life-sustaining (patients not wishing to receive cardiopulmonary resuscitation (cpr) can participate if other medical treatments will be given) have signed a do no resuscitate (dnr) form

Number of arms
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University of British Columbia

Inclusion age min
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

Canada;France

Type of patients
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

341

primary outcome
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mortality

Notes
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

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

Phase 3

Arms
Last imported at : Feb. 17, 2023, noon
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 86, "treatment_name": "Angiotensin receptor blocker (arb)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]