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Trial - NCT04643691


Column Value
Trial registration number NCT04643691
Full text link
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04643691

First author
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Pierre SIMEONE

Contact
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

pierre.simeone@ap-hm.fr

Registration date
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-11-25

Recruitment status
Last imported at : Nov. 7, 2022, noon
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

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

single-center

Study aim
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - adult patient - patient with respiratory distress requiring oxygen support of 6 liters per minute or more. - news-score greater than 6 pcr sars-cov-2 positive in a pharyngeal or respiratory specimen, - informed consent

Exclusion criteria
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- minor patient, - patient deprived of liberty, - refusal of the patient to participate in the study, - patient for whom measures of therapeutic limitation have been issued justifying the absence of recourse to mechanical ventilation, - patient of 80 years or older, - pregnant or breastfeeding woman, - patient with prior treatment with ara2 or ace inhibitors, - hypotension justifying treatment with norepinephrine, - acute renal failure with a clearance of less than 60ml/min, - severe liver failure. - intolerance or contraindication to losartan or spironolactone

Number of arms
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Assistance Publique Hopitaux De Marseille

Inclusion age min
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

90

primary outcome
Last imported at : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

SOFA score

Notes
Last imported at : Nov. 27, 2020, 12:31 a.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 : Nov. 27, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1617, "treatment_name": "Losartan+spironolactone", "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"}]