Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19

COVID-19 Clinical Trial

— Co-Vim  

Official title:

Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04904692
• Other study ID #: BC-07492
• Status: Active, not recruiting
• Start date: March 23, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: September 30, 2024
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Blood draw
8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
• Bronchoalveolar lavage
Only in case of diagnostic or therapeutic indication.
• SARS CoV-2 swabs
Nasopharyngeal, oropharyngeal and nasal swabs

Locations

Country	Name	City	State
Belgium	AZ Jan Palfijn	Gent	Oost-Vlaanderen
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen
Belgium	UZ Gent	Gent	Oost-Vlaanderen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Ghent	Chan Zuckerberg Initiative, Flanders Institute for Biotechnology, Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of cytokines and chemokines associated with COVID-19 severity and outcome.	Cytokine and chemokine analysis (U-plex Mesoscale Diagnostics) on the plasma and BAL fluid will be correlated to disease severity and outcome	6 months
Primary	Identification of cellular subsets that can predict COVID-19 severity and outcome.	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.	6 months
Primary	SARS CoV-2 sequencing.	Whole genome sequencing and viral metagenomics analysis will be performed on selected nasopharyngeal swabs and bronchoalveolar lavage fluid.	6 months
Secondary	Single-cell RNA sequencing of BAL fluid and matched PBMC samples.	Single -cell RNA sequencing will be performed on fresh BAL fluid and matched PBMCs by using 10X Genomics technology. The aim of the project is to study the transcriptional activity in different immune cells in the lung in COVID-19 patients with differing disease severity and compare these to non-COVID-19 respiratory infections.	6 months
Secondary	Measurement of plasma hydroxychloroquine and N-desethylhydroxychloroquine (REVIVE).	In this pilot substudy (REVIVE study), the investigators aim to measure plasma hydroxychloroquine, measuring range 10-2250 ng/mL, and the active metabolite, plasma N-desethylhydroxychloroquine, measuring range 2-2250 ng/m, in patients treated with hydroxychloroquine.	6 months
Secondary	Analysis of micronutrients Cu, Fe and Zn in plasma samples from COVID-19 + and COVID-19 - patients.	Total serum or plasma concentrations (mg/L) of Cu, Fe and Zn will be measured using a benchtop TXRF spectrometer (S4 T-STAR, Bruker Nano GmbH, Berlin, Germany) by prof. Gijs Du Laing and the laboratory of Prof. Lutz Schomburg.	12 months
Secondary	Analysis of micronutrient Se in plasma samples from COVID-19 + and COVID-19 - patients.	Total serum or plasma concentrations (µg/L) of Se will be measured using a benchtop TXRF spectrometer (S4 T-STAR, Bruker Nano GmbH, Berlin, Germany) by prof. Gijs Du Laing and the laboratory of Prof. Lutz Schomburg.	12 months