BudesonidePhase 3COVIDORLNCT04361474
Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
A Phase 3 study testing Budesonide Nasal and Physiological serum in people with Budesonide and Olfaction Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Budesonide, Olfaction Disorders, SARS-CoV-2
- What is being tested?
- Budesonide Nasal and Physiological serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2020to 25 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
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.
Read the 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.
- Conditions
- Budesonide, Olfaction Disorders, SARS-CoV-2, Anosmia
- Being tested
- Budesonide Nasal, Physiological serum
- Medical subject headings
- Olfaction Disorders, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide NasalDrug
Also called Experimental group
Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
Physiological serumOther
Also called Control group
Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physiological serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start18 May 2020
- Primary completion24 Nov 2020
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BudesonideStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with persistent hyposmia related to a SARS-CoV-2 infection
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Hopital Lariboisière
- Responsible party
- Sponsor
- Investigators
- Mary DAVAL, Principal investigator, Hopital Fondation A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361474
- Sponsor's protocol ID
- MDL_2020_10
- Other IDs
- 2020-001667-85
- Acronym
- COVIDORL
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2020
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37652094Daval 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.
PubMed 32690074
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
- ClinicalTrials.gov ID
- NCT04361474
- Acronym / sponsor ID
- COVIDORL / MDL_2020_10
- Conditions
- Budesonide, Olfaction Disorders, SARS-CoV-2, Anosmia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Hopital Lariboisière
- Study start
- 18 May 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with persistent hyposmia related to a SARS-CoV-2 infection
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Budesonide NasalNasal 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. |
| Control group | Placebo comparator | Other: Physiological serumNasal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide NasalAlso: Experimental groupNasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day. | Drug | Experimental group |
| Physiological serumAlso: Control groupNasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day. | Other | Control group |
Primary outcome
Patient with more than 2 points on the ODORATEST
Time frame: 30 days
Percentage of patients with an improvement of more than 2 points on the ODORATEST score (5) after 30 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 37652094Hautefort 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.
- Derived from this study: PubMed 32690074Daval 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary DAVAL principal investigator
Hopital Fondation A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide Nasal and Physiological serum in people with Budesonide and Olfaction Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient with more than 2 points on the ODORATEST (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04361474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.