Amélie YAvchitz
Paris, 75019, France
NCT Number: NCT04361474
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Paris, 75019, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
Other names: Experimental group
Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.
Other names: Control group
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
Fondation Ophtalmologique Adolphe de Rothschild
Network
A Randomized Controlled Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
Acronym: COVIDORL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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