Clinical trial NCT04904692: Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19
Official title: Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Chan Zuckerberg Initiative
name: Flanders Institute for Biotechnology
First posted: 2021-05-27
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients hospitalised with symptoms with upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19, who require hospitalisation.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of cytokines and chemokines associated with COVID-19 severity and outcome.
timeFrame: 6 months
measure: Identification of cellular subsets that can predict COVID-19 severity and outcome.
timeFrame: 6 months
measure: SARS CoV-2 sequencing.
timeFrame: 6 months
Secondary outcomes:
measure: Single-cell RNA sequencing of BAL fluid and matched PBMC samples.
timeFrame: 6 months
measure: Measurement of plasma hydroxychloroquine and N-desethylhydroxychloroquine (REVIVE).
timeFrame: 6 months
measure: Analysis of micronutrients Cu, Fe and Zn in plasma samples from COVID-19 + and COVID-19 - patients.
timeFrame: 12 months
measure: Analysis of micronutrient Se in plasma samples from COVID-19 + and COVID-19 - patients.
timeFrame: 12 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Jan Palfijn
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Linos Vandekerckhove, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: