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Trial - NCT04401423


Column Value
Trial registration number NCT04401423
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04401423

First author
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Jeanine D'Armiento, MD, PhD

Contact
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

jmd12@cumc.columbia.edu

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

2020-05-26

Recruitment status
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Completed

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

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-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: - severe covid-19: adult patients admitted to the hospital through the emergency department (ed) requiring oxygen therapy (any level) to maintain oxygen saturation (sao2) > 90% - covid positive by polymerase chain reaction (pcr) on hospital admission - hospitalized patients aged 18 years or greater

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

- pre-existing chronic kidney disease - new use of or change in dose of ace-inhibitors or angiotensin receptor blocker (arb) within the last 6 months - acute kidney injury at the time of enrollment defined as either increase pf serum creatinine by more than 50% or 0.3 mg/dl above baseline or estimated creatinine clearance (by mdrd) of less than 60 ml/min (if no baseline serum creatinine available) - pregnant and breastfeeding women - contraindicated medications: new use or change of medications from start of trial (start of an ace inhibitor or arb within 6 months of trial).

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

Columbia University

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

70

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

United States

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

Moderate/severe disease at enrollment

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

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

22

primary outcome
Last imported at : July 28, 2022, 3 p.m.
Source : ClinicalTrials.gov

Change of Serum Creatinine;Number of Participants Requiring Intubation

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

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

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 85, "treatment_name": "Angiotensin 1-7", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]