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

Ghent University Hospital (UZ)

Status: Active, not recruiting

Conditions: COVID-19

Treatments: Procedure: SARS CoV-2 swabs; Procedure: Bronchoalveolar lavage; Procedure: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT04904692

BC-07492

Details and patient eligibility

About

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).

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

109 participants in 2 patient groups

COVID-19 positive

Description:

Peripheral blood draw: * Day 1 of admission: blood draw. * Day 7-10 of hospitalization: blood draw. * Follow-up consultation: blood draw (selected patients). Bronchoscopic sampling: Material from bronchoscopic sampling (lavage fluid) will be collected only in those subjects in whom there is a diagnostic or therapeutic need for this procedure. Swabs for SARS-CoV-2 PCR: * Day 1 of admission: Extra oropharyngeal, nasal and nasopharyngeal (NP) swabs will be collected after the result of the initial diagnostic swab is known. In case of shortage of swabs, sputum samples will be collected as an alternative. * Day 7-14 of hospitalization: NP swab or clinically available alternative will be executed on day 7 repeated weekly.

Treatment:

Procedure: Bronchoalveolar lavage

Procedure: Blood draw

Procedure: SARS CoV-2 swabs

COVID-19 negative

Description:

Peripheral blood draw: * Day 1 of admission: blood draw. * Follow-up consultation: blood draw (selected patients). Bronchoscopic sampling: Material from bronchoscopic sampling (lavage fluid) will be collected only in those subjects in whom there is a diagnostic or therapeutic need for this procedure. Swabs for SARS-CoV-2 PCR: o Day 1 of admission: Extra oropharyngeal, nasal and nasopharyngeal (NP) swabs will be collected after the result of the initial diagnostic swab is known. In case of shortage of swabs, sputum samples will be collected as an alternative.

Treatment:

Procedure: Bronchoalveolar lavage

Procedure: Blood draw

Procedure: SARS CoV-2 swabs