A randomized controlled trial evaluating the efficacy of local budesonide therapy in the management of hyposmia in COVID-19 patients without signs of severity

A randomized controlled trial evaluating the efficacy of local budesonide therapy in the management of hyposmia in COVID-19 patients without signs of severity - COVIDORL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001667-85-FR

Enrollment

120

Registered

2020-04-28

Start date

2020-05-15

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with persistent hyposmia related to a SARS-CoV-2 infection

Interventions

Trade Name: Budesonide Teva 1mg/2ml, suspension pour inhalation par nébuliseur en récipient unidose Pharmaceutical Form: Nebuliser suspension Pharmaceutical form of the placebo: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 apperance, 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion 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, telithromycin, nefazodone and HIV protease inhibitors); - Severe forms of SARS-CoV-2 with respiratory or other signs ; - Hyposmia persisting for more than 45 days after the onset of symptoms - Other causes of hyposmia found on interrogation or MRI; - Patient benefiting from a legal protection measure ; - Pregnant or breastfeeding woman

Design outcomes

Primary

Measure	Time frame
Main Objective: To 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;Secondary Objective: 1-In patients who have fully recovered after 30 days of treatment, to assess the persistence of olfactory recovery 1 month after stopping treatment. 2-In the budesonide-treated group, in COVID-19 patients who have not fully recovered after 30 days of treatment, to assess the benefit of continuing budesonide for an additional 30 days. 3-In the control group, in COVID-19 patients who have not fully recovered after 30 days of treatment, to assess the benefit of initiating budesonide therapy for 30 days. 4-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. 5-To assess safety of budenoside. 6-To describe patients' olfactory and taste capacities using a self-assessment questionnaire ;Primary end point(s): Percentage of patients with an improvement of more than 2 points on the ODORATEST score (5) after 30 days of treatment;Timepoint(s) of evaluation of this end point: D30	—

Measure

Time frame

Main Objective: To 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;Secondary Objective: 1-In patients who have fully recovered after 30 days of treatment, to assess the persistence of olfactory recovery 1 month after stopping treatment. 2-In the budesonide-treated group, in COVID-19 patients who have not fully recovered after 30 days of treatment, to assess the benefit of continuing budesonide for an additional 30 days. 3-In the control group, in COVID-19 patients who have not fully recovered after 30 days of treatment, to assess the benefit of initiating budesonide therapy for 30 days. 4-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. 5-To assess safety of budenoside. 6-To describe patients' olfactory and taste capacities using a self-assessment questionnaire ;Primary end point(s): Percentage of patients with an improvement of more than 2 points on the ODORATEST score (5) after 30 days of treatment;Timepoint(s) of evaluation of this end point: D30

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Secondary

Measure	Time frame
Secondary end point(s): 1- Percentage of patients with an improvement of more than 2 points on the ODORATEST score 30 days after the end of treatment (i.e. 60 days after randomization). 2- Percentage of patients with an improvement of more than 2 points on the ODORATEST score after 60 days of treatment with budesonide. 3- Percentage of patients with an improvement of more than 2 points on the ODORATEST score 30 days after initiation of budesonide therapy (i.e. 60 days after randomization). 4- Presence of an inflammatory filling of the olfactory cleft on MRI or presence of a neurological damage to the olfactory bulb. 5- Description of adverse events and serious adverse events. 6- Self-assessment questionnaire. ;Timepoint(s) of evaluation of this end point: D30 an D60	—

Measure

Time frame

Secondary end point(s): 1- Percentage of patients with an improvement of more than 2 points on the ODORATEST score 30 days after the end of treatment (i.e. 60 days after randomization). 2- Percentage of patients with an improvement of more than 2 points on the ODORATEST score after 60 days of treatment with budesonide. 3- Percentage of patients with an improvement of more than 2 points on the ODORATEST score 30 days after initiation of budesonide therapy (i.e. 60 days after randomization). 4- Presence of an inflammatory filling of the olfactory cleft on MRI or presence of a neurological damage to the olfactory bulb. 5- Description of adverse events and serious adverse events. 6- Self-assessment questionnaire. ;Timepoint(s) of evaluation of this end point: D30 an D60

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Countries

France

Contacts

Public ContactClinical research Director

HôpiTal Fondation Adolphe de Rothschild

pvachey@for.paris

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026