Nasal Epithelial Genetic and Single Cell RNA COVID-19 Study

NCT04359459 | Withdrawn

• 1 other identifier: CIPOLLINI
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients. Objective: The main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development. Study design: Prospective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \& 3 at day 3, at day 14, and before detubation Study population: A total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups: Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation. Main study parameters/endpoints: The primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Nasal epithelial transcriptional response to SARS-CoV2

  To assess how the nasal epithelial transcriptional response to SARS-CoV2 is different in patients with mild, severe, or very severe disease.

  Observational-baseline

Secondary Outcomes (1)

• ACE2-AngII system

  Observational-baseline

Study Arms (3)

Mild COVID-19

Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.

Severe COVID-19

Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.

Very Severe COVID-19

Patients with very severe disease admitted to intensive care, who require mechanical ventilation.

Eligibility Criteria

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

Study Population

Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.

You may qualify if:

• Patients have to be tested (PCR) positive for SARS-CoV2 infection.
• Provided written informed consent

You may not qualify if:

• \. No comprehension of Dutch or English language

Sponsors & Collaborators

• University Medical Center Groningen: lead

Biospecimen

Retention: SAMPLES WITH DNA

* Blood sampling: 1x serum, 1x plasma + buffycoat, 1x protease inhibitor tube, 1x PAXgene RNA tube * Nasal brushes: 5 nasal brushes will be collected, 1x RNAProtect Cell solution, 2x 10Xgenomic (single cell sequencing), 1 x DNA methylation in empty tube, 1 x in 2mL universal virus transport medium. * Stool sample - 1 tube

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Dirk-Jan Slebos, MD PhD

  UMCG, Department of pulmonology

  PRINCIPAL INVESTIGATOR

• Janesh Pillay, MD PhD

  UMCG, Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: November 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11