Identification of Novel Factors Leading to Activated Macrophage Expansion in COVID19 - INFLAME Study
INFLAME
1 other identifier
observational
2,000
1 country
1
Brief Summary
This project aims to undertake a high-resolution analysis of previous cases of COVID19 infection to determine from all available clinical data recorded over the timeline of admission, who might benefit best from specific interventions designed to target a hyper inflammatory response in this condition. This approach offers a timely contribution to the field where the first phase of unselected clinical trials is already underway, and the second phase will require a more targeted approach. Southampton offers a unique opportunity to undertake this work, as it is widely accepted that the investigators lead the UK in clinical data informatics. This project links the investigators research efforts at the clinical level to current understanding of disease pathways, for which the investigators have effective interventions and the problem the investigators aim to solve is, who will benefit from the available novel anti-inflammatory approaches and when should this treatment be given?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2024
CompletedMay 27, 2021
May 1, 2021
4 years
May 25, 2021
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality in those groups with high Soton hyperinflammation score vs low score
Death recorded. Higher scores associated with increased mortality.
Day 28
Secondary Outcomes (2)
Mortality in those groups with and without secondary Haemophagocytic lymphohistiocytosis
Day 28
Comparison of HScore (0-302) vs Soton hyperinflammation score (0-44)
within 2 days following virus diagnosis
Study Arms (2)
COVID-19 - no hyperinflammation
Confirmed Sars-CoV-2 infection Hospitalised case
COVID-19 - hyperinflammation
Sars-CoV-2 infection Hospitalised case
Interventions
Score for hyperinflammation defined by blood parameters and other physiological measurements
Score for secondary haemophagocytic lymphohistiocytosis validated in prior publications
Eligibility Criteria
All individuals with possible COVID19 at University Hospitals NHS Foundation Trust will be included. As a further control group, a control cohort will be recruited, reflecting various key stratification aspects of the COVID19 patient cohort (e.g. by age and sex, or by hyperinflammation status) from hospital inpatients without a COVID19 diagnosis.
You may qualify if:
- Sars-CoV-2 confirmed
- Hospitalized case
You may not qualify if:
- Sars-CoV-2 not confirmed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Ardern-Jones, DPhil FRCP
University of Southampton
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 27, 2021
Study Start
June 30, 2020
Primary Completion
June 24, 2024
Study Completion
June 24, 2024
Last Updated
May 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- starting 6 months after publication
Data will be disclosed only upon request and approval of the proposed use of the data by the chief investigator of the INFLAME study, and in alignment with the relevant governance and ethical approval. Data will be de-identified for participant, key identifying factors and will be available with a signed data access agreement.