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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 : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Hopital Lariboisière
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.


Condition or disease Intervention/treatment Phase
Budesonide Olfaction Disorders SARS-CoV-2 Anosmia Drug: Budesonide Nasal Other: Physiological serum Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with persistent hyposmia related to a SARS-CoV-2 infection
Masking: Single (Participant)
Masking Description: Patients with persistent hyposmia related to a SARS-CoV-2 infection
Primary Purpose: Treatment
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 : May 18, 2020
Estimated Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 60 days after onset of symptoms;
  • Other causes of hyposmia revealed on interrogation or an MRI;

Information from the National Library of Medicine

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


Contacts
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Contact: Mary Daval 0148036870 mdaval@for.paris
Contact: Amélie Yavchitz 0148036870 ayavchitz@for.paris

Locations
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France
Amélie YAvchitz Recruiting
Paris, France, 75019
Contact: Amélie Yavchitz       ayavchitz@for.paris   
Principal Investigator: Mary Daval         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Hopital Lariboisière
Investigators
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Principal Investigator: Mary DAVAL Hopital Fondation A de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04361474    
Other Study ID Numbers: MDL_2020_10
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists