COVID-19FORECASTNCT04377815
Finding Out if COVID-19 Infection Can be pREdicted by ChAnges in Smell and/or Taste
An observational study of COVID-19 and Anosmia, run by University College, London at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- General Public cohort
- How many people
- 569 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Apr 2020to 24 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Admitted to hospital due to COVID-19 and documentation of either presense or absence of loss/reduced sense of smell and/or taste.
Who cannot join
- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University College London Hospital
London, WC1E 6JF
GP Practices
London
About this study
Official title: 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.
Read the 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.
- Being tested
- General Public cohort
- Keywords
- COVID-19, anosmia, taste
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Public cohortOther
Also called Hospital cohort
No intervention is being tested
| Study group | Role | What they receive |
|---|---|---|
| General Public cohort | General Public Receives: Other: General Public cohort | |
| Hospital cohort | Medical records of patients hospitalised due to COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of people reporting changes in smell/taste
percentage of people who report loss/reduced sense of smell or taste
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Percentage of people with change in smell/taste before other symptoms
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
Measured: 4 weeks
proportion of other COVID-19 linked symptoms in people with smell and/or taste change
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.
Measured: 4 weeks
Percentage of people with persistent changes in smell and/or taste
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
Measured: 12 weeks
Percentage of hospitalisation
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
Measured: 12 weeks
co-morbidities association
To investigate whether loss/reduced sense of smell and/or taste are associated with the course of illness and outcomes in COVID-19
Measured: through study completion, an average of 1 year
prevalence of changes in smell/taste
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.
Measured: through study completion, an average of 1 year
clinical outcomes
Correlating the presence of loss/decrease in sense of smell and/or taste changes to clinical outcomes including case fatality rate.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start23 Apr 2020
- Primary completion14 May 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377815
- Sponsor's protocol ID
- 132311
- Other IDs
- 20/HRA/1879
- Acronym
- FORECAST
- Status last verified
- Jan 2021
- First submitted
- 24 Apr 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33632171Makaronidis 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.
PubMed 33001967
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FORECAST Study: Finding Out if COVID-19 Infection Can be pREdicted by ChAnges in Smell and/or Taste
- ClinicalTrials.gov ID
- NCT04377815
- Acronym / sponsor ID
- FORECAST / 132311
- Keywords
- COVID-19, anosmia, taste
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Public cohort | – | Other: General Public cohortGeneral Public |
| Hospital cohort | – | –Medical records of patients hospitalised due to COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Public cohortAlso: Hospital cohortNo intervention is being tested | Other | General Public cohort |
Primary outcome
Percentage of people reporting changes in smell/taste
Time frame: 4 weeks
percentage of people who report loss/reduced sense of smell or taste
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.
7 secondary outcomes
Percentage of people with change in smell/taste before other symptoms
Time frame: 4 weeks
proportion of other COVID-19 linked symptoms in people with smell and/or taste change
Time frame: 4 weeks
Percentage of people with persistent changes in smell and/or taste
Time frame: 12 weeks
Percentage of hospitalisation
Time frame: 12 weeks
co-morbidities association
Time frame: through study completion, an average of 1 year
prevalence of changes in smell/taste
Time frame: through study completion, an average of 1 year
clinical outcomes
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 33632171Makaronidis 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.
- Derived from this study: PubMed 33001967Makaronidis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Anosmia, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of people reporting changes in smell/taste (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377815, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.