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Trial - NCT04359511


Column Value
Trial registration number NCT04359511
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04359511

First author
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Sylvain MARCHAND-ADAM

Contact
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

s.marchandadam@univ-tours.fr

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

2020-04-24

Recruitment status
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

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 : May 15, 2021, 12:32 a.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: - adult patients ≥ 18 years old, - hospitalized with a proven diagnosis of covid-19 (sars-cov-2 positive in rtpcr), in medicine or in intensive care. - with a need for oxygen therapy ≥ 2 l / min to maintain a sp02> 92% or a need for oxygen therapy to maintain a pao2 / fio2> 300 mmhg (for intubated patients). - with a chest scanner at least 7 days after the onset of symptoms, and whose centralized interpretation shows a ct scan aspect suggestive of intense and predominant dad which can explain the patient's oxygen dependence. - signature of a free, written and informed consent by the patient, or the person of trust - affiliate or beneficiary of a social security scheme.

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

- patients already treated by cs for a chronic disease. - patients with a known contraindication to sc, such as hypersensitivity. - patients at risk of dying within 48 hours. - pregnant or breastfeeding women. - patients under guardianship, curatorship, safeguard of justice. - poor understanding of the french language.

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

University Hospital, Tours

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

None

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

Moderate disease at enrollment

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

3: Moderate disease at enrollment

Total sample size
Last imported at : May 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

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

Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days.

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 3

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

[{"arm_notes": "", "treatment_id": 1021, "treatment_name": "Prednisone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]