Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity (COVIDORL)
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|ClinicalTrials.gov Identifier: NCT04361474|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : May 12, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Budesonide Olfaction Disorders SARS-CoV-2 Anosmia||Drug: Budesonide Nasal Other: Physiological serum||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients with persistent hyposmia related to a SARS-CoV-2 infection|
|Masking Description:||Patients with persistent hyposmia related to a SARS-CoV-2 infection|
|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|
|Actual Study Start Date :||May 18, 2020|
|Actual Primary Completion Date :||November 24, 2020|
|Estimated Study Completion Date :||June 25, 2021|
Experimental: Experimental group
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
Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
Other Name: Experimental group
Placebo Comparator: Control group
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
Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.
Other Name: Control group
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361474
|Paris, France, 75019|
|Principal Investigator:||Mary DAVAL||Hopital Fondation A de Rothschild|