Anosmia and Covid-19

Study Overview
=================
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.

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

Conditions
-----------------
Anosmia, SARS CoV 2 Infection

Intervention / Treatment
-----------------
* Other: Olfactory Training


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |