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

January 15, 2021 updated by: University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The main of objective of this study is to investigate whether loss/or reduced sense of smell and/or taste in the absence of fever and/or persistent cough are indicative of Coronavirus Infectious disease 2019 (COVID-19) infection. In addition, the study aims to investigate whether loss/or reduced sense of smell and/or taste precede the development of fever and persistent cough in people with COVID-19 infection and also whether loss of/reduced sense of smell and/or taste changes can be used to predict the clinical course of the disease.

General public FORECAST: Participants over the age of 18 will be sent a text message invite through participating GP practices' patient messaging systems. This will direct participants to a website (hosted by Dendrite Clinical Systems) where study subjects will find the participant information sheet, screening checks and consent form. Enrolled participants will complete an online questionnaire containing questions about smell and taste changes, as well as other symptoms of COVID-19. Participants will then be sent a near-patient rapid antibody test kit for COVID-19 to be undertaken only under medical supervision. Participants will be booked for a video conference appointment with either a doctor or nurse and the screening test will be performed under medical supervision. The outcome of the test will be documented, discussed with the patient and appropriate advice given. Four weeks after completing the first questionnaire participant will be sent an email and / or text message asking them to complete a second questionnaire.

This second questionnaire will contain questions about resolution of smell/taste symptoms and other symptoms of COVID-19. In case COVID-19 positive patients are subsequently admitted to hospital as a result of COVID-19, consent will be obtained to collect information on the outcome of the admission from discharge letter via GP. The data obtained will be analysed to determine if smell/taste symptoms alone are indicative of COVID-19 infection, whether smell/taste symptoms are early symptoms fo COVID-19 infection and whether smell/taste changes can be used to predict the clinical course of COVID-19 disease.

Hospital FORECAST: clinical records of patients admitted to University College London Hospital (UCLH) and the Whittington Hospital as a result of COVID-19 will be reviewed. The clinical notes of COVID-19 positive patients where absence or presence of smell/taste changes have been documented will be selected for review. Anonymised clinical data will be collected about symptoms on admission, the course of illness and outcomes. The study primary outcome will be to compare case fatility rate in COVID-19 postivite with documented history of loss/reduced sense of smell and/or taste compared to COVID-19 postive with documented history of no loss/reduced sense of smell and/or taste. The study will investigate whether loss/reduced sense of smell and/or taste can predict the course of illness and outcomes in COVID-19.

Study Type

Observational

Enrollment (Actual)

569

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 6JF
        • University College London Hospital
      • London, United Kingdom
        • GP practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

General public FORECAST cohort: Participants will confirm their eligibility on the online form by confirming they meet the following inclusion and exclusion criteria:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pre-existing smell or taste impairment of longer than 6 weeks duration;
  • People lacking capacity.

Hospital FORECAST cohort: The patient records to be included in this part of the study will be selected by a healthcare professional based on the following inclusion and exclusion criteria

Inclusion Criteria:

  • Admitted to hospital due to COVID-19 and documentation of either presense or absence of loss/reduced sense of smell and/or taste.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General Public cohort
General Public
Other: General Public cohort
No intervention is being tested
Other Names:
  • Hospital cohort
Hospital cohort
Medical records of patients hospitalised due to COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of people reporting changes in smell/taste
Time Frame: 4 weeks
percentage of people who report loss/reduced sense of smell or taste
4 weeks
mortality rate
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of people with change in smell/taste before other symptoms
Time Frame: 4 weeks
To identify the percentage of people who report changes in taste and/or smell before developing either fever or persistent cough who are positive for SARS-CoV-2 IgM and IgG
4 weeks
proportion of other COVID-19 linked symptoms in people with smell and/or taste change
Time Frame: 4 weeks
To examine the proportion of other COVID-19 linked symptoms in people with smell and/or taste change who are positive positive for SARS-CoV-2 IgM and IgG who never develop fever and/or cough.
4 weeks
Percentage of people with persistent changes in smell and/or taste
Time Frame: 12 weeks
To determine the percentage of people whose smell and/or taste symptoms persist for greater than 4 weeks in people who are positive for SARS-CoV-2 IgM and IgG
12 weeks
Percentage of hospitalisation
Time Frame: 12 weeks
To determine the percentage of patients who report loss/decrease in sense of smell and/or taste changes before or in the absence of other symptoms of COVID-19, who are admitted to hospital with COVID-19
12 weeks
co-morbidities association
Time Frame: through study completion, an average of 1 year
To investigate whether loss/reduced sense of smell and/or taste are associated with the course of illness and outcomes in COVID-19
through study completion, an average of 1 year
prevalence of changes in smell/taste
Time Frame: through study completion, an average of 1 year
Assessing the prevalence of previous loss/decrease in sense of smell and/or taste changes in patients admitted to secondary care with COVID-19 infection.
through study completion, an average of 1 year
clinical outcomes
Time Frame: through study completion, an average of 1 year
Correlating the presence of loss/decrease in sense of smell and/or taste changes to clinical outcomes including case fatality rate.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2020

Primary Completion (ACTUAL)

May 14, 2020

Study Completion (ACTUAL)

June 24, 2020

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132311
  • 20/HRA/1879 (OTHER: Queen Square REC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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