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Trial - NCT05122182


Column Value
Trial registration number NCT05122182
Full text link
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05122182

First author
Last imported at : April 1, 2023, 8 a.m.
Source : ClinicalTrials.gov

Meg Jardine

Contact
Last imported at : April 1, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

2021-11-16

Recruitment status
Last imported at : April 1, 2023, 8 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adults aged ≥ 18 years (maximum 65 years old in india). laboratory-confirmed diagnosis of sars-cov-2 infection within 10 days prior to randomisation. (confirmation must be through reverse transcription polymerase chain reaction [rt-pcr] method) intended for hospital admission for management of covid-19. patients with moderate (respiratory rate of ≥ 24/minute or spo2: 90% to ≤ 93% on room air) or severe (respiratory rate of ≥ 30/minute or spo2: <90% on room air) covid-19. systolic blood pressure (sbp) ≥ 120 mmhg or sbp ≥ 115 mmhg and currently treated with a non-raasi bp lowering agent that can be ceased. willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. documented informed consent.

Exclusion criteria
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

currently treated with an acei, arb or aldosterone antagonist, aliskiren, or arni intolerance of arbs serum potassium >5.5 mmol/l an estimated glomerular filtration rate (egfr) <30ml/min/1.732m known biliary obstruction, known severe hepatic impairment (child-pugh-turcotte score 10-15) pregnancy, lactation, or inadequate contraception. participation in a study of a novel investigational product within 28 days prior to randomisation. plans to participate in another study of a novel investigational product during this study.

Number of arms
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

University of Sydney

Inclusion age min
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 30, 2022, 3 p.m.
Source : ClinicalTrials.gov

India

Type of patients
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : April 1, 2023, 8 a.m.
Source : ClinicalTrials.gov

49

primary outcome
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Clinical Health Score at day 14

Notes
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 248, "treatment_name": "Candesartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2063, "treatment_name": "Candesartan+repagermanium", "treatment_type": "Cardiovascular agents+other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]