Anosmia and Covid-19

NCT05246059 | Completed

• 2 other identifiers: EDGE132692IRAS No. 283758
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

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.

Conditions

Anosmia; SARS CoV 2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of Life Score

  12-weeks

• Compliance (anecdotal)

  12-weeks

• Safety (anecdotal)

  12-weeks

Study Arms (2)

Control

NO INTERVENTION

12 weeks of observation, safety information provided

Treatment

EXPERIMENTAL

12-weeks of daily olfactory training

Other: Olfactory Training

Interventions

Olfactory Training OTHER

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Study Sites (4)

Barts Health NHS Foundation Trust

London, England, United Kingdom

Location

Guy's and St. Thomas' NHS Foundation Trust

London, England, United Kingdom

Location

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, England, United Kingdom

Location

James Paget and Norfolk & Norwich University Hospitals

Gorleston-on-Sea, Great Yarmouth, United Kingdom

Location

MeSH Terms

Conditions

Anosmia; COVID-19

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Valerie J. Lund, MD FRCS

  University College, London

  PRINCIPAL INVESTIGATOR

• Matt Lechner, MD FRCS

  University College London, Barts Health NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 18, 2022
• Study Start: June 3, 2020
• Primary Completion: August 8, 2021
• Study Completion: August 8, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)