Anosmia and Covid-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2021-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Pathogenesis of Olfactory Disorders in COVID-19

NCT04366934

Coronavirus Infection Severe Acute Respiratory Syndrome Sars-CoV2

COMPLETED

COVID-19 Anosmia Study

NCT04495816

Anosmia Covid19

COMPLETED PHASE2

Efficacy of Olfactive Training on Loss of Smell and Taste Caused by SARS CoV2 COVID-19 (Covid-Smell)

NCT07190911

COVID - 19

COMPLETED NA

Rapid Screening for Olfactory Disorders in Covid-19 Infection

NCT04696601

Olfaction Disorders COVID-19 Testing

WITHDRAWN NA

Olfactory Training As a Treatment for Olfactory Dysfunction Post COVID-19

NCT05384561

Hyposmia COVID-19 Parosmia +2 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anosmia SARS CoV 2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

12 weeks of observation, safety information provided

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

12-weeks of daily olfactory training

Group Type EXPERIMENTAL

Olfactory Training

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olfactory Training

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)