Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19
- 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
- Upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19
- Requiring hospitalization
- 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
Name Time Method 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
Name Time Method 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