Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection

NCT04466982 | Completed

• 1 other identifier: REC Ref: 20/SC/0231
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to investigate the acuity of olfactory dysfunction in COVID-19 positive patients in the United Kingdom. In particular defining severity with objective testing and determining if this has any predictive value on the outcome of the SARS CoV-2 infection. In addition, this study will strive to determine duration / natural history of olfactory dysfunction in these patients in respect to a positive SARS CoV-2 diagnosis. It should also demonstrate the impact of olfactory dysfunction on patient Quality of Life (QOL).

Conditions

Olfactory Disorder; COVID19; SARS-CoV-2; Anosmia; Microsomia; Smell Disorder; Quality of Life

Outcome Measures

Primary Outcomes (1)

• UPSIT scores

  I. Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients

  At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study

Secondary Outcomes (3)

• UPSIT scores

  at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

• eQOD scores

  at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

• SNOT 22 scores

  at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group will comprise patients diagnosed with the SARS Cov-2 infection at the local site.

You may qualify if:

• Patients who are presenting to hospital with symptoms of SARS CoV-2 infection.
• Patients who go on to develop a positive SARS CoV-2 test.
• Patients who can give a valid written informed consent.
• Patients who are motivated to participate in the study.
• Adult patients aged 18 years - 85 years.

You may not qualify if:

• Patients who cannot give a valid written informed consent.
• Patients who are not willing or not motivated to participate in the study.
• Patients with negative SARS CoV-2 tests.
• Patients with nasal pathologies like severe deviated nasal septum, nasal masses, head trauma or previously known chronic rhinosinusitis with polyps or on medication for more than 6 months/year for at least one year for chronic rhinosinusitis.
• Patients with any diagnosed neurological disease known to affect olfactory function will be excluded from the study.
• Patients unable to read in the English language.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Imperial College Healthcare NHS Trust: collaborator
• Royal Cornwall Hospitals Trust: collaborator

Study Sites (3)

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Anosmia; Fetal Growth Retardation; Olfaction Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Otolaryngology, Head & Neck Surgery

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 10, 2020
• Study Start: July 2, 2020
• Primary Completion: December 30, 2022
• Study Completion: March 30, 2023
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)