Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity (COVIDORL)

August 2, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

A Randomized Controlled Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Amélie YAvchitz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

Hopital Lariboisière

Investigators

  • Principal Investigator: Mary DAVAL, Hôpital Fondation A de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Actual)

November 24, 2020

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDL_2020_10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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