COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04361474

Mary DAVAL

mdaval@for.paris

2020-04-24

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - patient over 18 years of age; - patient with a suspected sars-cov-2 infection in a epidemic context, whether or not confirmed by pcr, or contact close to a pcr-confirmed case, typical chest ct scan (unsystematized frosted glass areas predominantly sub-pleural, and at a later stage of alveolar condensation with no excavations neither nodules nor masses) or positive serology ; - patient with isolated acute hyposmia persisting at d30. of the onset of signs of ca-mrsa-cov-2 infection; - absence of pcr-confirmed sars-cov-2 portage at the time of inclusion

- known hypersensitivity to budesonide or to any of the excipients of the medicine; - hemostasis disorder, or epistaxis; - oromo-oral-nasal and ophthalmic herpes virus infection; - long-term corticosteroid treatment; - treatment with potent cyp3a4 inhibitors (e.g., cyp3a4 inhibitors); ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and hiv proteases) ; - forms of cov-2-sars with respiratory signs or other than anosmia persisting at 30 days from the onset of symptoms; - hyposmia persisting for more than 90 days after onset of symptoms; - other causes of hyposmia revealed on interrogation or an mri;

2

Fondation Ophtalmologique Adolphe de Rothschild

18

None

France

No restriction on type of patients

0: No restriction on type of patients

120

Patient with more than 2 points on the ODORATEST

None

Phase 3

[{"arm_notes": "", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]