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Anosmia and Covid-19 (COVANOS)

Primary Purpose

Anosmia, SARS CoV 2 Infection

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Olfactory Training
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anosmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed (positive laboratory antigen test) or suspected COVID-19 infection
  • Sudden onset of smell loss
  • Smell loss of at least 4 weeks
  • Reduced smell function through psycho-physical testing (Brief Smell Identification Test score of 8 or less)

Exclusion Criteria:

-

Sites / Locations

  • Barts Health NHS Foundation Trust
  • Guy's and St. Thomas' NHS Foundation Trust
  • Wrightington, Wigan and Leigh NHS Foundation Trust
  • James Paget and Norfolk & Norwich University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

12 weeks of observation, safety information provided

12-weeks of daily olfactory training

Outcomes

Primary Outcome Measures

Brief Smell Identification Test (BSIT)
The absolute difference between the intervention and control arms in BSIT score smell improvement, measured as a change from baseline at 12-weeks.

Secondary Outcome Measures

Quality of Life Score
Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline
Compliance (anecdotal)
Participant compliance to olfactory training through anecdotal reporting
Safety (anecdotal)
Safety of the use of Sniffin' Sticks through anecdotal reporting

Full Information

First Posted
February 17, 2022
Last Updated
February 17, 2022
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT05246059
Brief Title
Anosmia and Covid-19
Acronym
COVANOS
Official Title
SARS-CoV-2 Infection/Covid-19 and Anosmia - Prevalence Study, Molecular Analysis and Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
August 8, 2021 (Actual)
Study Completion Date
August 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

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
Our study aims to determine the prevalence of anosmia in patients SARS-Cov-2/Covid-19 infection (both by symptom reporting and smell testing), the efficacy of early olfactory training for the treatment of anosmia caused by infection and the long-term impact of smell dysfunction with a one-year follow-up.
Detailed Description
Around 10-15% of patients with acquired anosmia have Post Viral Olfactory Loss (PVOL). Coronaviruses are a known cause for anosmia. At the onset of the COVID-19 pandemic, reports from China, South Korea, US and Europe suggest that a significant proportion of COVID-19 patients describe a loss of smell and taste as the only symptoms or as part of mild flu-like symptoms. It is now well-established that these symptoms are important components of the COVID-19 sequelae with persistent dysfunction described in a subset of individuals. For this study, individuals, mainly comprising mainly healthcare workers in the UK, with persistent and sudden loss of sense of smell (at least 4 weeks) were recruited to ascertain the prevalence of COVID-19 associated smell dysfunction. A positive COVID-19 test was not a requirement for participation if not readily available nor accessible, however, information regarding COVID-19 antigen and antibody testing was collected post-hoc from those for who data are readily available. All participants (n=227) underwent initial psychophysical smell testing using the Brief Smell Identification Test (BSIT), gustatory testing using Taste Strips and completed the Smell Qx questionnaire. This questionnaire collected relevant demographic information, medical history, details of COVID-19 symptoms experienced, as well as information on olfactory and gustatory function, including those related to quality-of-life. Participants, who scored 8 or below on the BSIT (indicative of semi-quantitative smell loss) were further invited to participate in the early olfactory training randomized controlled trial. Participants were randomized to undergo either 12 weeks of olfactory training or receive safety information. At the end of the 12-weeks, participants completed a follow-up BSIT and survey. All participants enrolled at baseline within the eligible timeframe, for whom a valid email address was available, were further invited to participate in 1 year follow-up assessments. This included all participants irrespective of baseline BSIT result and RCT participation. The follow-up included a final electronic survey and BSIT. In addition to questions related to their sense of smell, which were identical to those in the baseline and 12-week follow-up surveys, participants were also asked about any symptoms of long-Covid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia, SARS CoV 2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
12 weeks of observation, safety information provided
Arm Title
Treatment
Arm Type
Experimental
Arm Description
12-weeks of daily olfactory training
Intervention Type
Other
Intervention Name(s)
Olfactory Training
Intervention Description
Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)
Primary Outcome Measure Information:
Title
Brief Smell Identification Test (BSIT)
Description
The absolute difference between the intervention and control arms in BSIT score smell improvement, measured as a change from baseline at 12-weeks.
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Quality of Life Score
Description
Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline
Time Frame
12-weeks
Title
Compliance (anecdotal)
Description
Participant compliance to olfactory training through anecdotal reporting
Time Frame
12-weeks
Title
Safety (anecdotal)
Description
Safety of the use of Sniffin' Sticks through anecdotal reporting
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed (positive laboratory antigen test) or suspected COVID-19 infection Sudden onset of smell loss Smell loss of at least 4 weeks Reduced smell function through psycho-physical testing (Brief Smell Identification Test score of 8 or less) Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie J. Lund, MD FRCS
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matt Lechner, MD FRCS
Organizational Affiliation
University College London, Barts Health NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Foundation Trust
City
London
State/Province
England
Country
United Kingdom
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
State/Province
England
Country
United Kingdom
Facility Name
Wrightington, Wigan and Leigh NHS Foundation Trust
City
Wigan
State/Province
England
Country
United Kingdom
Facility Name
James Paget and Norfolk & Norwich University Hospitals
City
Gorleston-on-Sea
State/Province
Great Yarmouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Anosmia and Covid-19

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