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OpenTrials
Completed

NCT Number: NCT05246059

Anosmia and Covid-19

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts Health NHS Foundation Trust, London, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Olfactory Training

Other

Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)

Primary outcomes

  1. Brief Smell Identification Test (BSIT)

    Time frame: 12-weeks

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

Secondary outcomes

  1. Quality of Life Score

    Time frame: 12-weeks

    Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline

  2. Compliance (anecdotal)

    Time frame: 12-weeks

    Participant compliance to olfactory training through anecdotal reporting

  3. Safety (anecdotal)

    Time frame: 12-weeks

    Safety of the use of Sniffin' Sticks through anecdotal reporting

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: COVANOS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2022
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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