Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19)

NCT04664075 | Terminated Results

• 1 other identifier: 20SM6170
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

Conditions

Influenza; SARS (Severe Acute Respiratory Syndrome); Respiratory Viral Infection; Respiratory Tract Infections; Infection, Bacterial; Infection Viral; Covid19; RNA Virus Infections

Keywords

Flu; Influenza; SARS-CoV-2; Covid19; Respiratory; Predict; Infection; RNA

Outcome Measures

Primary Outcomes (3)

• Describe the Aetiology of Influenza-like Illness in Hospitalised Adults

  The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

  Day 0 to Day 28

• Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults

  Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.

  Day 0 to Day 28

• Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults

  Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults

  Day 0 to Day 28

Secondary Outcomes (1)

• Identify Changes in Cytokine Levels During Influenza-like Illness in Hospitalised Adults

  Day 0 to Day 28

Interventions

Respiratory infections BIOLOGICAL

With biological samples and longitudinal observations, the aim is to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In-patients admitted to hospital with a confirmed or suspected respiratory infection.

You may qualify if:

• Healthy persons aged ≥ 18, and able to give informed consent
• Patient is admitted to hospital
• Primary reason for hospital admission is clinical suspicion of a new episode of ARI
• Onset of the following symptoms within the last 7 days: i. Sudden onset of self-reported fever OR temperature of ≥ 38°C at presentation AND ii. At least one respiratory symptom (cough, sore throat, runny or congested nose, dyspnoea) AND iii. At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness).

You may not qualify if:

• Patient lacks capacity to provide informed consent
• Patient has been transferred from another hospital
• Patient has been previously enrolled in the study

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and nasal scrapes (using RhinoPro) for analysis by transcriptomics and qPCR.

MeSH Terms

Conditions

Influenza, Human; Severe Acute Respiratory Syndrome; Respiratory Tract Infections; Bacterial Infections; Virus Diseases; COVID-19; RNA Virus Infections; Infections

Interventions

Cold Temperature

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Bacterial Infections and Mycoses; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Limitations and Caveats

This study only recruited 8 participants of the 100 total recruitment target.

Results Point of Contact

• Title: Senior Clinical Research Nurse
• Organization: Imperial College London

flu-rsv-study@imperial.ac.uk

02083833231

Study Officials

• Christopher Chiu, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 11, 2020
• Study Start: January 25, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available approximately 12 months from the last patient's last visit and remain available indefinitely
• Access Criteria: According to study protocol

Locations

GB (1)