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Trial - NCT04356495


Column Value
Trial registration number NCT04356495
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04356495

First author
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Denis MALVY

Contact
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

denis.malvy@chu-bordeaux.fr

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

2020-04-22

Recruitment status
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

Completed

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

Open label

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

multi-center

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

Treatment

Inclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - clinical picture suggestive of covid-19 dated 7 days or less. - positivity of a test proving an acute sars-cov-2 infection, according to current recommendations. - absence of criteria for hospitalization or oxygen therapy according to current recommendations. - age : - greater than or equal to 60 years of age without any risk factor - or between 50 and 59 years of age and the presence of at least one of the following risk factors : - arterial hypertension under treatment (all stages) - obesity (bmi ≥30 kg/m2) - diabetes under treatment (all types) - ischemic heart disease (all stages) - heart failure (all stages) - stroke history - chronic obstructive pulmonary disease (all stages) - stage 3 chronic renal failure (30 ≤ estimated gfr < 60 ml/min/1.73 m²) - malignancies (solid tumours or blood malignancies) that are progressive or were diagnosed less than 5 years ago. - immunodeficiency - of therapeutic origin (solid organ transplant or hematopoietic stem cell transplant, cancer chemotherapy, immunosuppressive therapy, corticosteroids > 15 mg/d of prednisone equivalent taken for at least 2 months); - hiv infection with cd4<200/mm3. - valid, ambulatory person, fully able to understand the issues of the trial - beneficiary of a social security scheme - signed informed consent

Exclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- asymptomatic person - inability to make a decision to participate (dementia, person under legal protection, curatorship or guardianship) - ongoing illness or chronic treatment contraindicated by taking one of the trial drugs.

Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4

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

University Hospital, Bordeaux

Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

50

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

France

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

Mild disease at enrollment

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

1: Mild disease at enrollment

Total sample size
Last imported at : Feb. 6, 2022, 2 p.m.
Source : ClinicalTrials.gov

412

primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Efficacy phase: Death;Efficacy phase: oxygen therapy;Pilot Phase: Proportion of participants who had a Grade 3 or 4 adverse event;Efficacy phase: hospitalization

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 2/Phase 3

Arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1274, "treatment_name": "Telmisartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 672, "treatment_name": "Interferon beta 1b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 282, "treatment_name": "Ciclesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1365, "treatment_name": "Vitamin", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]