Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesTo assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severity and with persistent hyposmia 30 days after the onset of symptoms.To search for an association between the presence of an obstruction on MRI and the severity of olfactory loss, at inclusion and after 30 days of treatment.Trial designTwo center, open-label, 2-arm (1:1 ratio) parallel group randomized controlled superiority trial.ParticipantsInclusion criteria- Patient over 18 years of age;- Patient with a suspected SARS-CoV-2 infection, whether or not confirmed by PCR, or close contact with a PCR-confirmed case, typical chest CT scan (unsystematic frosted glass patches with predominantly sub-pleural appearance, and at a later stage, alveolar condensation without excavation or nodules or masses) or positive serology ;- Patient with isolated sudden onset hyposmia persisting 30 days after the onset of symptoms of CoV-2 SARS infection;- Affiliate or beneficiary of a social security scheme;- Written consent to participate in the study.Non-inclusion criteria- Known hypersensitivity to budesonide or any of the excipients;- Hemostasis disorder or epistaxis;- Oral-nasal and ophthalmic herpes virus infection;- Long-term corticosteroid treatment;- Treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin...
Source: Trials - Category: Research Source Type: clinical trials