Anosmia and Covid-19 (COVANOS)

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

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.

Study Overview

• Status: Completed
• Conditions: Anosmia; SARS CoV 2 Infection
• Intervention / Treatment: Other: Olfactory Training

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 12 weeks of observation, safety information provided
Experimental: Treatment; 12-weeks of daily olfactory training	Other: Olfactory Training; Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Valerie J. Lund, MD FRCS, University College, London; Principal Investigator: Matt Lechner, MD FRCS, University College London, Barts Health NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): August 8, 2021
• Study Completion (Actual): August 8, 2021

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; COVID-19; Infections; Anosmia
• Other Study ID Numbers: EDGE132692; IRAS No. 283758 (Other Identifier: NHS Health Research Authority)

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