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

NCT ID: NCT04904692

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-23

Study Completion Date

2024-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 positive

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.

Blood draw

Intervention Type PROCEDURE

8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.

Bronchoalveolar lavage

Intervention Type PROCEDURE

Only in case of diagnostic or therapeutic indication.

SARS CoV-2 swabs

Intervention Type PROCEDURE

Nasopharyngeal, oropharyngeal and nasal swabs

COVID-19 negative

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.

Blood draw

Intervention Type PROCEDURE

8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.

Bronchoalveolar lavage

Intervention Type PROCEDURE

Only in case of diagnostic or therapeutic indication.

SARS CoV-2 swabs

Intervention Type PROCEDURE

Nasopharyngeal, oropharyngeal and nasal swabs

Interventions

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Blood draw

8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.

Intervention Type PROCEDURE

Bronchoalveolar lavage

Only in case of diagnostic or therapeutic indication.

Intervention Type PROCEDURE

SARS CoV-2 swabs

Nasopharyngeal, oropharyngeal and nasal swabs

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

Chan Zuckerberg Initiative

OTHER

Sponsor Role collaborator

Flanders Institute for Biotechnology

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linos Vandekerckhove, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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AZ Jan Palfijn

Ghent, Oost-Vlaanderen, Belgium

Site Status

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

Site Status

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BC-07492

Identifier Type: -

Identifier Source: org_study_id

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