Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity (COVIDORL)
Primary Purpose
Budesonide, Olfaction Disorders, SARS-CoV-2
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Budesonide Nasal
Physiological serum
Sponsored by
About this trial
This is an interventional treatment trial for Budesonide
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
Sites / Locations
- Amélie YAvchitz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04361474
First Posted
April 22, 2020
Last Updated
August 2, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Hopital Lariboisière
1. Study Identification
Unique Protocol Identification Number
NCT04361474
Brief Title
Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
Acronym
COVIDORL
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
November 24, 2020 (Actual)
Study Completion Date
June 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Hopital Lariboisière
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Budesonide, Olfaction Disorders, SARS-CoV-2, Anosmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients with persistent hyposmia related to a SARS-CoV-2 infection
Masking
Participant
Masking Description
Patients with persistent hyposmia related to a SARS-CoV-2 infection
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Budesonide Nasal
Other Intervention Name(s)
Experimental group
Intervention Description
Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
Intervention Type
Other
Intervention Name(s)
Physiological serum
Other Intervention Name(s)
Control group
Intervention Description
Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.
Primary Outcome Measure Information:
Title
Patient with more than 2 points on the ODORATEST
Description
Percentage of patients with an improvement of more than 2 points on the ODORATEST score (5) after 30 days of treatment
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary DAVAL
Organizational Affiliation
Hopital Fondation A de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amélie YAvchitz
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32690074
Citation
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.
Results Reference
derived
Learn more about this trial
Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity
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