PROSAIC-19 - Prospective Longitudinal Assessment in a COVID-19 Infected Cohort

NCT04444609 | Unknown

• 1 other identifier: 20IC5943
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

DESIGN Longitudinal prospective observational multicentre study. Primary objective: Understand the immune mechanisms driving COVID-19 disease in patients with a history of lung disease

Conditions

COVID-19; SARS-CoV 2; ARDS, Human; Immune System Disorder

Outcome Measures

Primary Outcomes (4)

• Anti-viral cytokine levels in blood samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Anti-viral cytokine protein concentration in blood samples by ELISA

  Through study completion an average of 1 year

• Anti-viral cytokines profiles within sputum samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Inflammatory cytokine protein concentration in sputum samples by ELISA

  Through study completion an average of 1 year

• Anti-viral cytokine profiles within nasal lavage samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection associated with susceptibility to severe COVID-19 infection

  Inflammatory cytokine protein concentration in nasal lavage samples by ELISA

  Through study completion an average of 1 year

• Expression of inflammatory gene expression in upper respiratory epithelial airway cells using nasal brush specimens in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Inflammatory gene expression in upper airway respiratory epithelial cells by RNA sequencing.

  Through study completion an average of 1 year

Secondary Outcomes (7)

• Identify the T cell antigens and B cell epitopes in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Through study completion an average of 1 year

• Peripheral blood mononuclear cell (PBMC) interferon mediated immune responses to pathogen recognition receptor agonists in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Through study completion an average of 1 year

• Identify endothelial function in chronic respiratory disease associated with susceptibility to severe COVID-19 infection using EndoPAT testing

  Through study completion an average of 1 year

• Endothelial cell inflammation biomarkers in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Through study completion an average of 1 year

• Identify sputum 16S rRNA and ITS sequences in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

  Through study completion an average of 1 year

Study Arms (4)

COVID -19 with chronic lung disease

Subjects with swab confirmed COVID-19 and underlying chronic lung disease (n=60) Severe (n=30) (defined by presence of ARDS, sepsis or severe pneumonia) Mild/Moderate ( n =30) (absence of severe criteria)

Other: Blood tests sputum, nasal lavage and brushing

COVID-19 without chronic lung disease

Subjects with swab confirmed COVID-19 and no chronic lung disease (n=60) Severe (n=30) (defined by presence of ARDS, sepsis or severe pneumonia) Mild/Moderate ( n =30) (absence of severe criteria)

Other: Blood tests sputum, nasal lavage and brushing

Chronic Lung disease

Subjects with chronic lung disease (identified as requiring shielding based on severity) but no COVID-19 (n=80) * Asthma (defined as severe) - (n=20) * CF (FEV1% predicted baseline \<50%) - (n=20) * COPD (FEV1% predicted baseline \<50%) - (n=20) * Idiopathic Pulmonary Fibrosis (n=20)

Other: Blood tests sputum, nasal lavage and brushing

Healthy volunteers

Healthy subjects with no COVID-19 (n=30)

Other: Blood tests sputum, nasal lavage and brushing

Interventions

Blood tests sputum, nasal lavage and brushing OTHER

Venesection, sputum nasal lavage and brushing if appropriate

Also known as: Blood tests, Sputum, Nasal lavage, Nasal brushings, EndoPAT

COVID -19 with chronic lung disease; COVID-19 without chronic lung disease; Chronic Lung disease; Healthy volunteers

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with swab confirmed COVID-19 and underlying chronic lung disease (n=60) * Severe (n=30) (defined by presence of ARDS, sepsis or severe pneumonia) * Mild/Moderate ( n =30) Absence of features of severe disease Subjects with swab confirmed COVID-19 and no chronic lung disease (n=60) * Severe (n=30) (defined by presence of ARDS, sepsis or severe pneumonia) * Mild/Moderate ( n =30) Absence of features of severe disease Subjects with chronic lung disease (identified as requiring shielding based on severity) but no COVID-19 (n=80) * Asthma (defined as severe) - (n=20) * CF (FEV1% predicted baseline \<50%) - (n=20) * COPD (FEV1% predicted baseline \<50%) - (n=20) * Idiopathic Pulmonary Fibrosis (n=20) 3.Healthy subjects with no COVID-19 (n=30)

You may qualify if:

• All patients ≥16 years old with confirmation of COVID-19
• All patients ≥ 16 years old with chronic lung disease (CF, non-CF bronchiectasis, asthma, COPD or Idiopathic Pulmonary Fibrosis) or with no evidence of prior chronic lung disease
• Healthy volunteers

You may not qualify if:

• None

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Royal Brompton & Harefileld NHS Trusts

London, SW3 6PP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Spontaneously expectorated sputum, nasal lavage, brushings and nasal synthetic absorptive matrix (SAM) samples Venous blood (60mls) will be taken into Lithium Heparin tubes and PAXgene RNA tubes PAXgene tubes will be stored at -80C for further host genetic sequencing analysis. Further immunological analysis using yeast surface display for serum antibody profiling, single B cell sorting to generate monoclonal antibodies and ELISPOT to analyse CD4 and CD8 T cell ELISPOT to SARS CoV-2 peptide pools.

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Immune System Diseases

Interventions

Nasal Lavage; Toothbrushing; Hematologic Tests

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; Respiration Disorders

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Oral Hygiene; Preventive Dentistry; Dentistry; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter Kelleher, MD PhD

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Peter Kelleher, MD PhD

CONTACT

00 44 (0) 331 58228; p.kelleher@imperial.ac.uk

Anand Shah, MD PhD

CONTACT

00 44 (0) 352 8121; s.anand@imperial.ac.uk

Study Design

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

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 23, 2020
• Study Start: June 18, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

GB (1)