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Clinical Trials/NCT04904692
NCT04904692Active, not recruitingNot Applicable

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

University Hospital, Ghent3 sites in 1 country109 target enrollmentStarted: March 23, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
109
Locations
3
Primary Endpoint
Identification of cytokines and chemokines associated with COVID-19 severity and outcome.

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

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.

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

  • Single-cell RNA sequencing of BAL fluid and matched PBMC samples.(6 months)
  • Analysis of micronutrient Se in plasma samples from COVID-19 + and COVID-19 - patients.(12 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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