Immune Defence COVID Pandemic Study
Research type
Research Study
Full title
Reducing recurrent respiratory infections in primary care: The Immune Defence COVID pandemic Study
IRAS ID
282321
Contact name
Paul Little
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Respiratory tract infections (RTIs; colds, sore throats, sinus, chest or ear infections, flu) are the commonest reason for people to be off work, to seek help from the NHS, and to be admitted to hospital in winter months. COVID-19 is a viral RTI that is currently causing a worldwide pandemic. During the pandemic period there have been, and will continue to be, a range of other viruses circulating which also cause RTIs. The combined effect of both the ‘normal’ viruses and the COVID virus still pose a significant risk to society and could still potentially causes a major problem for the NHS during the coming 2020-21 winter season. There is promising evidence that using nasal sprays, or alternatively reducing stress and increasing exercise, could help people’s immune defences, reduce the number of people getting infections, reduce how severe illnesses are and how long they last.
The NIHR has funded the RECUR Programme to develop and trial interventions to reduce the incidence of infections. We have developed a website called IMMUNE DEFENCE which will help us to see if using nasal sprays or getting more physically active and reducing stress can help people get fewer of these types of infections. We have involved both a range of patients and also patient representatives as collaborators in the design of our study to help ensure the procedures are relevant and appropriate to patients. We had initially planned a large feasibility study this year in the 2020-21 winter season, and a full trial in a normal year in the 2021-2023 winter seasons. However, the stage of development this year and our previous experience of running large similar trials we are planning a much larger full trial among at risk groups to help address prevention during the COVID pandemic in a timely manner.
This study will involve approximately 200 GP practices nationally and up to 20,000 patients who are at risk from respiratory infections. Patients will be invited to take part in the study through invitation letters from their GP surgery, Eligible patients will be randomised to one of the following groups for 12 months: i) Antiviral nasal spray (Vicks First Defence) ii) Saline nasal spray, iii) Getting Active and Reducing Stress or iv) Usual Care. Participants will be asked to complete monthly questionnaires for 6 months, and more detailed questions at 6 months and a year about any infections and about their general health. Patients happy to do so will perform a swab of their nose to send off to see what virus is causing the illness, and/or complete a daily diary of symptoms if they do become unwell to give a more detailed understanding of the course of each illness A sample patients and healthcare practitioners will be asked to take part in a telephone interview about their experiences of taking part in the trial.REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0127
Date of REC Opinion
4 Aug 2020
REC opinion
Unfavourable Opinion