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

NCT04361474 | Completed Phase 3

• 2 other identifiers: MDL_2020_102020-001667-85
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient with more than 2 points on the ODORATEST

  Percentage of patients with an improvement of more than 2 points on the ODORATEST score (5) after 30 days of treatment

  30 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Budesonide Nasal

Control group

PLACEBO COMPARATOR

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.

Other: Physiological serum

Interventions

Budesonide Nasal DRUG

Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.

Also known as: Experimental group

Experimental group

Physiological serum OTHER

Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Hopital Lariboisière: collaborator

Study Sites (1)

Amélie YAvchitz

Paris, 75019, France

Location

Related Publications (2)

• Hautefort C, Corre A, Poillon G, Jourdaine C, Housset J, Eliezer M, Verillaud B, Slama D, Ayache D, Herman P, Yavchitz A, Guillaume J, Herve C, Bakkouri WE, Salmon D, Daval M. Local budesonide therapy in the management of persistent hyposmia in suspected non-severe COVID-19 patients: Results of a randomized controlled trial. Int J Infect Dis. 2023 Nov;136:70-76. doi: 10.1016/j.ijid.2023.08.022. Epub 2023 Aug 29.

  PMID: 37652094 RESULT

• Daval M, Corre A, Palpacuer C, Housset J, Poillon G, Eliezer M, Verillaud B, Slama D, Ayache D, Herman P, Jourdaine C, Herve C, El Bakkouri W, Salmon D, Hautefort C. 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. Trials. 2020 Jul 20;21(1):666. doi: 10.1186/s13063-020-04585-8.

  PMID: 32690074 DERIVED

MeSH Terms

Conditions

Olfaction Disorders; Anosmia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mary DAVAL

  Hopital Fondation A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients with persistent hyposmia related to a SARS-CoV-2 infection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: May 18, 2020
• Primary Completion: November 24, 2020
• Study Completion: June 25, 2021
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)