Profiling the Inflammatory Cascade of COVID-19

NCT06511024 | Completed

• 1 other identifier: AC20054
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 is a new and poorly understood virus. It is imperative that the scientific community develops an understanding of the viral mechanisms and human immunological response in order to develop effective therapies and assess their efficacy. This research study is being initiated in response to the ongoing COVID-19 pandemic and will provide much needed insight into the temporal immune response which can lead to rapid respiratory failure in infected patients.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Determine levels of cytokines and chemokines to elucidate the temporal inflammatory cascade in COVID-19

  We will determine levels of select cytokines and chemokines in plasma and serum samples from patients and control subjects.

  Up to 20 days

Secondary Outcomes (1)

• Identification, quantification and phenotyping of inflammatory cells and biomarkers.

  Up to 20 days

Study Arms (2)

COVID-19

* Patients in the community * Patients at hospital admission * Rapidly deteriorating patients * Ventilated, critically ill patients With confirmed COVID-19 infection

Other: Blood sample

Control

No clinical suspicion of COVID-19 infection

Other: Blood sample

Interventions

Blood sample OTHER

Serial blood sampling to monitor immune cells in patient with COVID 19 infection and compare with control group who have no evidence of COVID-19 infection

COVID-19; Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 COVID-19 Patients with confirmed COVID-19 infection (n=200) Cohort 2 Control Patients who have not tested positive for COVID-19 infection (n=20)

You may qualify if:

• All participants:
• Aged over 16 years
• Provision of consent (either from the patient or by a personal legal representative)
• COVID-19 Cohort only:
• Confirmed COVID-19 infection
• Control Cohort only:
• No clinical suspicion of COVID-19

You may not qualify if:

• All participants:
• Deemed unsuitable for participation by attending clinician

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and other clinically available samples (e.g. BAL)

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: July 19, 2024
• Study Start: May 12, 2020
• Primary Completion: April 10, 2021
• Study Completion: August 10, 2022
• Last Updated: October 16, 2024

Record last verified: 2024-07

Locations

GB (1)