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Trial - NCT04508985


Column Value
Trial registration number NCT04508985
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04508985

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

Abhinav Sharma, MD

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

abhinav.sharma@mcgill.ca

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

2020-08-11

Recruitment status
Last imported at : Oct. 3, 2022, 7 a.m.
Source : ClinicalTrials.gov

Unknown

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

Sequential assignment

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

unclear

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: - age ≥ 18 years old. - hospitalization with a covid-19 infection - chronically treated with raas blockers (ace inhibitors or arbs on the last prescription prior to admission with a treatment duration ≥ 1 month - diagnosis of covid-19 confirmed by the presence of sars-cov-2 on any biological sample - participants are within 48 hours of diagnosis of covid-19 or have received a diagnosis of covid-19 from another facility and are within 48 hours of transfer to a study recruitment site

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

- shock requiring vasoactive agents. - requiring invasive mechanical ventilation. - history of malignant hypertension - use of five or more antihypertensive drugs. - history of heart failure with reduced ejection fraction - history of hospitalization for acute heart failure in past 3 months - history of hospitalization for hemorrhagic stroke in the past 3 months. - history of ckd with an egfr <45 ml/min/1.73m2 - history of copd gold iii/iv - history of end-stage dementia - history of active liver cirrhosis - raas blockers therapy previously stopped > 48h. - anticipated discharge in less than 24 hours. - history of current active cancer receiving chemotherapy - inability to obtain informed consent.

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

McGill University Health Centre/Research Institute of the McGill University Health Centre

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

100

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

None

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

40

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

Global rank score

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

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

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

[{"arm_notes": "", "treatment_id": 1104, "treatment_name": "Renin-angiotensin-system-blockade", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 412, "treatment_name": "Discontinuation renin-angiotensin-system-blockad", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]