Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19

NCT04904692 | Active Not Recruiting

• 1 other identifier: BC-07492
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a prospective, observational multicentric study. The study population entails adult patients hospitalized with a high clinical suspicion of COVID-19 and consists of two study arms (SARS-CoV2- vs. SARS-CoV2+).This combined fundamental research project has a dual goal: on the one hand assessing immunological predisposing factors for severe infection and investigating the immunological impact of SARS-CoV2 infection, on the other hand studying viral characteristics. Furthermore, a substudy will examine the pharmacokinetics and pharmacodynamics of hydroxychloroquine in patients receiving this antiviral treatment (REVIVE susbstudy). To answer these research questions, samples will be collected from patients with a high clinical suspicion of COVID-19, hospitalized at UZ Gent and 2 participating hospitals in Ghent (AZ Maria Middelares en AZ Jan Palfijn).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Identification of cytokines and chemokines associated with COVID-19 severity and outcome.

  Cytokine and chemokine analysis (U-plex Mesoscale Diagnostics) on the plasma and BAL fluid will be correlated to disease severity and outcome

  6 months

• Identification of cellular subsets that can predict COVID-19 severity and outcome.

  By using high-dimensional flow cytometry on cryopreserved PBMCs, the investigators will assess whether the phenotype and intracellular signaling can predict COVID-19 severity and disease outcome.

  6 months

• SARS CoV-2 sequencing.

  Whole genome sequencing and viral metagenomics analysis will be performed on selected nasopharyngeal swabs and bronchoalveolar lavage fluid.

  6 months

Secondary Outcomes (4)

• Single-cell RNA sequencing of BAL fluid and matched PBMC samples.

  6 months

• Measurement of plasma hydroxychloroquine and N-desethylhydroxychloroquine (REVIVE).

  6 months

• Analysis of micronutrients Cu, Fe and Zn in plasma samples from COVID-19 + and COVID-19 - patients.

  12 months

• Analysis of micronutrient Se in plasma samples from COVID-19 + and COVID-19 - patients.

  12 months

Study Arms (2)

COVID-19 positive

Peripheral blood draw: * Day 1 of admission: blood draw. * Day 7-10 of hospitalization: blood draw. * Follow-up consultation: blood draw (selected patients). Bronchoscopic sampling: Material from bronchoscopic sampling (lavage fluid) will be collected only in those subjects in whom there is a diagnostic or therapeutic need for this procedure. Swabs for SARS-CoV-2 PCR: * Day 1 of admission: Extra oropharyngeal, nasal and nasopharyngeal (NP) swabs will be collected after the result of the initial diagnostic swab is known. In case of shortage of swabs, sputum samples will be collected as an alternative. * Day 7-14 of hospitalization: NP swab or clinically available alternative will be executed on day 7 repeated weekly.

Procedure: Blood draw; Procedure: Bronchoalveolar lavage; Procedure: SARS CoV-2 swabs

COVID-19 negative

Peripheral blood draw: * Day 1 of admission: blood draw. * Follow-up consultation: blood draw (selected patients). Bronchoscopic sampling: Material from bronchoscopic sampling (lavage fluid) will be collected only in those subjects in whom there is a diagnostic or therapeutic need for this procedure. Swabs for SARS-CoV-2 PCR: o Day 1 of admission: Extra oropharyngeal, nasal and nasopharyngeal (NP) swabs will be collected after the result of the initial diagnostic swab is known. In case of shortage of swabs, sputum samples will be collected as an alternative.

Procedure: Blood draw; Procedure: Bronchoalveolar lavage; Procedure: SARS CoV-2 swabs

Interventions

Blood draw PROCEDURE

8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.

COVID-19 negative; COVID-19 positive

Bronchoalveolar lavage PROCEDURE

Only in case of diagnostic or therapeutic indication.

COVID-19 negative; COVID-19 positive

SARS CoV-2 swabs PROCEDURE

Nasopharyngeal, oropharyngeal and nasal swabs

COVID-19 negative; COVID-19 positive

Eligibility Criteria

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

Study Population

The study population consists of patients hospitalised with symptoms with upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19, who require hospitalisation.

You may qualify if:

• Upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19
• Requiring hospitalization

You may not qualify if:

• Known pregnancy at the time of screening
• Inability to give informed consent or absence of legal representative who can give informed consent.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator
• Chan Zuckerberg Initiative: collaborator
• Flanders Institute for Biotechnology: collaborator

Study Sites (3)

AZ Jan Palfijn

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, PBMC), bronchoalveolar lavage fluid, nasopharyngeal swabs

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection; Bronchoalveolar Lavage

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; Therapeutic Irrigation

Study Officials

• Linos Vandekerckhove, Prof. MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: May 27, 2021
• Study Start: March 23, 2020
• Primary Completion: July 23, 2020
• Study Completion: September 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months

Locations

BE (3)