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Active Not RecruitingNCT04904692

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
109 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREBlood draw8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
PROCEDUREBronchoalveolar lavageOnly in case of diagnostic or therapeutic indication.
PROCEDURESARS CoV-2 swabsNasopharyngeal, oropharyngeal and nasal swabs

Timeline

Start date
2020-03-23
Primary completion
2020-07-23
Completion
2024-09-30
First posted
2021-05-27
Last updated
2024-09-19

Locations

3 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04904692. Inclusion in this directory is not an endorsement.