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NCT Number: NCT04904692

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Jan Palfijn, Ghent, Oost-Vlaanderen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draw

Procedure

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

Bronchoalveolar lavage

Procedure

Only in case of diagnostic or therapeutic indication.

SARS CoV-2 swabs

Procedure

Nasopharyngeal, oropharyngeal and nasal swabs

Primary outcomes

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

    Time frame: 6 months

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

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

    Time frame: 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.

  3. SARS CoV-2 sequencing.

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Chan Zuckerberg Initiative
  • Flanders Institute for Biotechnology
  • Fund for Scientific Research, Flanders, Belgium

Registry information

Acronym: Co-Vim

Important dates

Study start
2020
Primary completion
2020
Study completion
2024
First posted
May 27, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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