Anosmia and Covid-19

SARS CoV 2 Infection Clinical Trial

— COVANOS  

Official title:

SARS-CoV-2 Infection/Covid-19 and Anosmia - Prevalence Study, Molecular Analysis and Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246059
• Other study ID #: EDGE132692
• Secondary ID: IRAS No. 283758
• Status: Completed
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: August 8, 2021

Study information

• Verified date: February 2022
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 8, 2021
• Est. primary completion date: August 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Anosmia
• COVID-19
• Infections

Intervention

Other:
• Olfactory Training
Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)

Locations

Country	Name	City	State
United Kingdom	James Paget and Norfolk & Norwich University Hospitals	Gorleston-on-Sea	Great Yarmouth
United Kingdom	Barts Health NHS Foundation Trust	London	England
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London	England
United Kingdom	Wrightington, Wigan and Leigh NHS Foundation Trust	Wigan	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12-weeks
Secondary	Quality of Life Score	Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline	12-weeks
Secondary	Compliance (anecdotal)	Participant compliance to olfactory training through anecdotal reporting	12-weeks
Secondary	Safety (anecdotal)	Safety of the use of Sniffin' Sticks through anecdotal reporting	12-weeks