Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 11:29 PM
Study NCT ID:
NCT04377815
Status:
None
Last Update Posted:
2021-01-19 00:00:00
First Post:
2020-04-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Finding Out if COVID-19 Infection Can be pREdicted by ChAnges in Smell and/or Taste
Sponsor:
None
Organization:
Study Overview
Official Title:
FORECAST Study: Finding Out if COVID-19 Infection Can be pREdicted by ChAnges in Smell and/or Taste
Status:
None
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORECAST
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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: