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Trial - NCT04765371


Column Value
Trial registration number NCT04765371
Full text link
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04765371

First author
Last imported at : May 24, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

Edouard DEVAUD

Contact
Last imported at : May 24, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

not reported

Registration date
Last imported at : Feb. 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-21

Recruitment status
Last imported at : May 24, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patient ≥ 18 years old - patient with sars-cov-2 pneumopathy documented by nasopharyngeal or bronchoalveolar lavage fluid rt-pcr or any documented clinical symptoms support by ct scan - patient with spao2 ≤ 94 % in room air (90% for patient with respiratory failure) and requiring an oxygen therapy - negative pregnancy test for women of childbearing age - informed and written informed consent (ic) obtained - patients with affiliation to the social security system

Exclusion criteria
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- patient with corticosteroids as background treatment (≥ 10 mg equivalent) - patient under supplemental oxygen > 6 l/min - immunocompromised patient (aids, bone marrow or solid organ transplants, etc.) - patient who received a corticosteroid dose within 3 days for covid-19 - medical history of hypersensitivity to prednisolone or dexamethasone; or lactose / galactose (excipients with known effect) - another active virus such hepatitis, herpes, varicella, shingles …. - psychotic state not controlled by treatment

Number of arms
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : July 28, 2023, 8 a.m.
Source : ClinicalTrials.gov

Hôpital NOVO

Inclusion age min
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : May 24, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

89

primary outcome
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mortality assessment at D28

Notes
Last imported at : Feb. 23, 2021, 12:31 a.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 : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1020, "treatment_name": "Prednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]