Finding Out if COVID-19 Infection Can be pREdicted by ChAnges in Smell and/or Taste

NCT04377815 | Completed

• 2 other identifiers: 13231120/HRA/1879
• Study Type: observational
• Target: 569
• Locations: 1 country
• Sites: 2

Brief Summary

The FORECAST Study is an observational cohort study looking at two cohorts of patients presenting with COVID-19: a general public cohort, aiming to investigate if new loss or reduced sense of smell and/or taste are early signs of COVID-19 and a hospital cohort, which will investigate if taste/smell changes can predict the clinical course of a COVID-19 infection.

Conditions

COVID-19; Anosmia

Keywords

COVID-19; anosmia; taste

Outcome Measures

Primary Outcomes (2)

• Percentage of people reporting changes in smell/taste

  percentage of people who report loss/reduced sense of smell or taste

  4 weeks

• mortality rate

  to compare the case mortality rate in COVID-19 patients who experienced smell/taste changes compared to mortality in those who did not experience smell/taste changes.

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Percentage of people with change in smell/taste before other symptoms

  4 weeks

• proportion of other COVID-19 linked symptoms in people with smell and/or taste change

  4 weeks

• Percentage of people with persistent changes in smell and/or taste

  12 weeks

• Percentage of hospitalisation

  12 weeks

• co-morbidities association

  through study completion, an average of 1 year

Study Arms (2)

General Public cohort

General Public

Other: General Public cohort

Hospital cohort

Medical records of patients hospitalised due to COVID-19

Interventions

General Public cohort OTHER

No intervention is being tested

Also known as: Hospital cohort

General Public cohort

Eligibility Criteria

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

Study Population

General public FORECAST cohort Participating GP practices will send out text messages to potentially eligible patients registered with the practice inviting those who have noticed a recent (within the past 4 weeks) change (loss/decrease) in their sense of smell and/or taste to take part in a research study related to COVID-19 infection. Hospital FORECAST cohort For Hospital FORECAST, patients admitted with COVID-19 to UCLH and The Whittington Hospital will be identified through clinical coding. Their records will be reviewed by an appropriately qualified healthcare professional against the study's inclusion/exclusion criteria.

You may not qualify if:

• Age over 18 years;
• Able to read and write English;
• Access to a computer or smartphone with internet access and ability to access video calling;
• Willingness to undertake a COVID-19 screening test;
• Willingness for their GP to be informed of their participation in the study.
• Pre-existing smell or taste impairment of longer than 6 weeks duration;
• People lacking capacity.
• Admitted to hospital due to COVID-19 and documentation of either presense or absence of loss/reduced sense of smell and/or taste.
• Changes in smell and/or taste either present or absent not documented.
• Admission due to other reason with later diagnosis of COVID-19 as an inpatient.
• Incomplete medical records.
• Patients with longstanding pre-existing smell and/or taste impairment.

Sponsors & Collaborators

• University College, London: lead

Study Sites (2)

University College London Hospital

London, WC1E 6JF, United Kingdom

Location

GP Practices

London, United Kingdom

Location

Related Publications (2)

• Makaronidis J, Firman C, Magee CG, Mok J, Balogun N, Lechner M, Carnemolla A, Batterham RL. Distorted chemosensory perception and female sex associate with persistent smell and/or taste loss in people with SARS-CoV-2 antibodies: a community based cohort study investigating clinical course and resolution of acute smell and/or taste loss in people with and without SARS-CoV-2 antibodies in London, UK. BMC Infect Dis. 2021 Feb 25;21(1):221. doi: 10.1186/s12879-021-05927-w.

  PMID: 33632171 DERIVED

• Makaronidis J, Mok J, Balogun N, Magee CG, Omar RZ, Carnemolla A, Batterham RL. Seroprevalence of SARS-CoV-2 antibodies in people with an acute loss in their sense of smell and/or taste in a community-based population in London, UK: An observational cohort study. PLoS Med. 2020 Oct 1;17(10):e1003358. doi: 10.1371/journal.pmed.1003358. eCollection 2020 Oct.

  PMID: 33001967 DERIVED

MeSH Terms

Conditions

COVID-19; Anosmia

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; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 6, 2020
• Study Start: April 23, 2020
• Primary Completion: May 14, 2020
• Study Completion: June 24, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

GB (2)