Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University Hospital, Ghent
- 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)