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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001667-85 | EudraCT Number |
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| Name | Class |
|---|---|
| Hopital Lariboisière | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide Nasal | Drug | Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary DAVAL | Hopital Fondation A de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amélie YAvchitz | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37652094 | Result | 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. | |
| 32690074 |
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Patients with persistent hyposmia related to a SARS-CoV-2 infection
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Patients with persistent hyposmia related to a SARS-CoV-2 infection
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| Physiological serum | Other | Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day. |
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| Derived |
| 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. |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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