COVID-19Co-VimNCT04904692
Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19
An observational study of COVID-19, run by University Hospital, Ghent at 3 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Blood draw, Bronchoalveolar lavage and SARS CoV-2 swabs
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 3 sitesBelgium
- Study dates
- 23 Mar 2020to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19
- Requiring hospitalization
Who cannot join
- Known pregnancy at the time of screening
- Inability to give informed consent or absence of legal representative who can give informed consent.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
AZ Jan Palfijn
Ghent, Oost-Vlaanderen, 9000
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
UZ Gent
Ghent, Oost-Vlaanderen, 9000
About this study
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
- COVID-19
- Being tested
- Blood draw, Bronchoalveolar lavage, SARS CoV-2 swabs
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
Bronchoalveolar lavageProcedure or surgery
Only in case of diagnostic or therapeutic indication.
SARS CoV-2 swabsProcedure or surgery
Nasopharyngeal, oropharyngeal and nasal swabs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood draw; Procedure: Bronchoalveolar lavage; Procedure: SARS CoV-2 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. Receives: Procedure: Blood draw; Procedure: Bronchoalveolar lavage; Procedure: SARS CoV-2 swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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.
Measured: 6 months
SARS CoV-2 sequencing.
Whole genome sequencing and viral metagenomics analysis will be performed on selected nasopharyngeal swabs and bronchoalveolar lavage fluid.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start23 Mar 2020
- Primary completion23 Jul 2020
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Chan Zuckerberg Initiative, Flanders Institute for Biotechnology
- Responsible party
- Sponsor
- Investigators
- Linos Vandekerckhove, Prof. MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904692
- Sponsor's protocol ID
- BC-07492
- Acronym
- Co-Vim
- Status last verified
- Sep 2024
- First submitted
- 28 May 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19
- ClinicalTrials.gov ID
- NCT04904692
- Acronym / sponsor ID
- Co-Vim / BC-07492
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Chan Zuckerberg Initiative, Flanders Institute for Biotechnology
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Procedure: Blood draw, Procedure: Bronchoalveolar lavage, Procedure: SARS CoV-2 swabsPeripheral 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. |
| COVID-19 negative | – | Procedure: Blood draw, Procedure: Bronchoalveolar lavage, Procedure: SARS CoV-2 swabsPeripheral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19
- Requiring hospitalization
Key exclusion criteria (2 listed)
- Known pregnancy at the time of screening
- Inability to give informed consent or absence of legal representative who can give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy. | Procedure or surgery | COVID-19 negative, COVID-19 positive |
| Bronchoalveolar lavageOnly in case of diagnostic or therapeutic indication. | Procedure or surgery | COVID-19 negative, COVID-19 positive |
| SARS CoV-2 swabsNasopharyngeal, oropharyngeal and nasal swabs | Procedure or surgery | COVID-19 negative, COVID-19 positive |
Primary outcome
Identification of cytokines and chemokines associated with COVID-19 severity and outcome.
Time frame: 6 months
Cytokine and chemokine analysis (U-plex Mesoscale Diagnostics) on the plasma and BAL fluid will be correlated to disease severity and outcome
Identification of cellular subsets that can predict COVID-19 severity and outcome.
Time frame: 6 months
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.
SARS CoV-2 sequencing.
Time frame: 6 months
Whole genome sequencing and viral metagenomics analysis will be performed on selected nasopharyngeal swabs and bronchoalveolar lavage fluid.
4 secondary outcomes
Single-cell RNA sequencing of BAL fluid and matched PBMC samples.
Time frame: 6 months
Measurement of plasma hydroxychloroquine and N-desethylhydroxychloroquine (REVIVE).
Time frame: 6 months
Analysis of micronutrients Cu, Fe and Zn in plasma samples from COVID-19 + and COVID-19 - patients.
Time frame: 12 months
Analysis of micronutrient Se in plasma samples from COVID-19 + and COVID-19 - patients.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linos Vandekerckhove, Prof. MD principal investigator
University Hospital, Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Ghent at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cytokines and chemokines associated with COVID-19 severity and outcome. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.