Status:
COMPLETED
Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
Hopital Lariboisière
Conditions:
Budesonide
Olfaction Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The initial symptoms described in the first cases of COVID-19 were mainly fever and respiratory signs. Recently, there has been an increase in cases of hyposmia without associated nasal obstruction or...
Detailed Description
This is a multicenter randomized trial to evaluate the efficacy of local budesonide (nasal irrigation) in the management of persistent hyposmia in COVID-19 patients.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04361474
Start Date
May 18 2020
End Date
June 25 2021
Last Update
January 6 2026
Active Locations (1)
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1
Amélie YAvchitz
Paris, France, 75019