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Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19

Active, not recruiting
Conditions
COVID-19
Registration Number
NCT04904692
Lead Sponsor
University Hospital, Ghent
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
109
Inclusion Criteria
  • Upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19
  • Requiring hospitalization
Exclusion Criteria
  • Known pregnancy at the time of screening
  • Inability to give informed consent or absence of legal representative who can give informed consent.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Identification of cytokines and chemokines associated with COVID-19 severity and outcome.6 months

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

Identification of cellular subsets that can predict COVID-19 severity and outcome.6 months

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.

SARS CoV-2 sequencing.6 months

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

Secondary Outcome Measures
NameTimeMethod
Single-cell RNA sequencing of BAL fluid and matched PBMC samples.6 months

Single -cell RNA sequencing will be performed on fresh BAL fluid and matched PBMCs by using 10X Genomics technology. The aim of the project is to study the transcriptional activity in different immune cells in the lung in COVID-19 patients with differing disease severity and compare these to non-COVID-19 respiratory infections.

Analysis of micronutrient Se in plasma samples from COVID-19 + and COVID-19 - patients.12 months

Total serum or plasma concentrations (µg/L) of Se will be measured using a benchtop TXRF spectrometer (S4 T-STAR, Bruker Nano GmbH, Berlin, Germany) by prof. Gijs Du Laing and the laboratory of Prof. Lutz Schomburg.

Measurement of plasma hydroxychloroquine and N-desethylhydroxychloroquine (REVIVE).6 months

In this pilot substudy (REVIVE study), the investigators aim to measure plasma hydroxychloroquine, measuring range 10-2250 ng/mL, and the active metabolite, plasma N-desethylhydroxychloroquine, measuring range 2-2250 ng/m, in patients treated with hydroxychloroquine.

Analysis of micronutrients Cu, Fe and Zn in plasma samples from COVID-19 + and COVID-19 - patients.12 months

Total serum or plasma concentrations (mg/L) of Cu, Fe and Zn will be measured using a benchtop TXRF spectrometer (S4 T-STAR, Bruker Nano GmbH, Berlin, Germany) by prof. Gijs Du Laing and the laboratory of Prof. Lutz Schomburg.

Trial Locations

Locations (3)

AZ Jan Palfijn

🇧🇪

Gent, Oost-Vlaanderen, Belgium

AZ Maria Middelares

🇧🇪

Gent, Oost-Vlaanderen, Belgium

UZ Gent

🇧🇪

Gent, Oost-Vlaanderen, Belgium

AZ Jan Palfijn
🇧🇪Gent, Oost-Vlaanderen, Belgium

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