Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity (COVIDORL)

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Completed; Phase 3

Conditions: Olfaction Disorders; Anosmia; SARS-CoV-2; Budesonide

Treatments: Drug: Budesonide Nasal; Other: Physiological serum

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04361474

2020-001667-85 (EudraCT Number)

MDL_2020_10

Details and patient eligibility

About

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 rhinorrhea. Although we do not yet know the long-term consequences of COVID-19 on olfaction, there is evidence in the literature demonstrating that post-viral hyposmias are an important source of long-term olfactory disorders, impacting quality of life.

Usually, the treatment of viral hyposmias is based on local and/or general corticosteroid treatment combined with saline nasal irrigation at the onset of signs. Because of the possible development of severe forms of the SARS-Cov-2 infection, the French Society of Otorhinolaryngology has advised against treatment by corticosteroid therapy and nasal irrigation. However, as the virus is present in the nasal fossae on average for 20 days, persistent hyposmia at 30 days would probably result from an inflammatory or neurological damage to the nasal slits or olfactory bulb. Local treatment with corticosteroids could then be instituted from 30 days after the onset of symptoms of COVID-19 without risk of dissemination.

In persistent hyposmia other than chronic rhinosinusitis, the only treatment that has proven its efficacy is nasal irrigation associated with budesonide and olfactory rehabilitation. However, this drug does not have marketing authorisation in France for this indication.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Nasal irrigation with budesonide and physiological saline (Budesonide 1mg/2mL diluted in 250mL of physiological saline 9°/00): 3 syringes of 20mL in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.

Treatment:

Drug: Budesonide Nasal

Control group

Placebo Comparator group

Description:

Nasal irrigation with physiological saline 9°/00 only: 3 syringes of 20cc in each nasal cavity, morning and evening, for 30 days, in addition to olfactory re-education twice a day.

Treatment:

Other: Physiological serum