COVID-19CIPOLLININCT04359459
Nasal Epithelial Genetic and Single Cell RNA COVID-19 Study
An observational study of COVID-19, run by University Medical Center Groningen.
Trial summary
Rationale: The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Nov 2022
- 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: Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.
Who may be able to join
- Patients have to be tested (PCR) positive for SARS-CoV2 infection.
- Provided written informed consent
Who cannot join
- 1. No comprehension of Dutch or English language
About this study
Official title: Nasal CIliated EPithelial Genetic And Single Cell RNA prOfiLes of miLd, Severe and Very Severe COVID-Nineteen patIents (CIPOLLINI) Study
Rationale:
The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients.
Read more
Objective:
The main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development.
Study design:
Prospective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \& 3 at day 3, at day 14, and before detubation
Study population:
A total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups:
Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.
Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.
Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.
Main study parameters/endpoints:
The primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.
Read the detailed description
Rationale:
The currently ongoing world-crippling pandemic with the new SARS-CoV2 virus shows the desperate and urgent need for a better understanding of the biological pathways activated by the virus inducing Coronavirus disease 2019 (COVID-19) in infected patients. A subset of COVID-19 patients develop very severe respiratory symptoms requiring hospital admission with or without the need for mechanical ventilation, whereas others experience mild flu-like symptoms. The biological mechanisms underlying this striking difference in clinical outcome and the long term consequences are unknown, yet a genetic factor seems likely. SARS-CoV2 enters cells via the ACE2 receptor and the activating protease TMPRSS2 which have recently been shown to be strongly enriched in nasal epithelium. The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients.
Objective:
The main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development.
Study design:
Prospective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \& 3 at day 3, at day 14, and before detubation. Study subjects will be retrospectively allocated to the groups.
Study population:
A total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups:
Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.
Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.
Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.
Main study parameters/endpoints:
The primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild COVID-19 | Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. | |
| Severe COVID-19 | Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. | |
| Very Severe COVID-19 | Patients with very severe disease admitted to intensive care, who require mechanical ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal epithelial transcriptional response to SARS-CoV2
To assess how the nasal epithelial transcriptional response to SARS-CoV2 is different in patients with mild, severe, or very severe disease.
Measured: Observational-baseline
Secondary outcomes (1)
ACE2-AngII system
To assess the role of the ACE2-AngII system during SARS-CoV2 in relation to disease outcome (mild, severe, very severy COVID)
Measured: Observational-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Nov 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: COVID-19 pandemie ended
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 Medical Center GroningenThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten van den Berge, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, UMCG, Department of pulmonologyJanesh Pillay, MD PhD, Principal investigator, UMCG, Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359459
- Sponsor's protocol ID
- CIPOLLINI
- Acronym
- CIPOLLINI
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal CIliated EPithelial Genetic And Single Cell RNA prOfiLes of miLd, Severe and Very Severe COVID-Nineteen patIents (CIPOLLINI) Study
- ClinicalTrials.gov ID
- NCT04359459
- Acronym / sponsor ID
- CIPOLLINI / CIPOLLINI
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemie ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Apr 2020 (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.
Rationale:
The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients.
Objective:
The main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development.
Study design:
Prospective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \& 3 at day 3, at day 14, and before detubation
Study population:
A total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups:
Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.
Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.
Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.
Main study parameters/endpoints:
The primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.
Detailed description
Rationale:
The currently ongoing world-crippling pandemic with the new SARS-CoV2 virus shows the desperate and urgent need for a better understanding of the biological pathways activated by the virus inducing Coronavirus disease 2019 (COVID-19) in infected patients. A subset of COVID-19 patients develop very severe respiratory symptoms requiring hospital admission with or without the need for mechanical ventilation, whereas others experience mild flu-like symptoms. The biological mechanisms underlying this striking difference in clinical outcome and the long term consequences are unknown, yet a genetic factor seems likely. SARS-CoV2 enters cells via the ACE2 receptor and the activating protease TMPRSS2 which have recently been shown to be strongly enriched in nasal epithelium. The investigators hypothesize that genetics and the nasal epithelial response to SARS-CoV2 are critical determinants of the immune response to viral infection, and predict clinical outcome in COVID-19 patients.
Objective:
The main objective is to assess whether genetic background and/or the nasal epithelial gene expression in response to SARS-CoV2 is different in patients with mild, severe or very severe disease. The secondary goal of this study is to investigate a) the role of the ACE2-AngII system during SARS-CoV2 in relation to outcome b) the long-term consequences of mild, severe, and very severe COVID-19 infection c) the association between mild, severe and very severe COVID-19 with clinical \& molecular markers of disease progression d) whether the faeces microbiome, virome or metabolomics profile predicts clinical outcome in COVID-19 patients and e) to investigate whether pre-existing antibodies towards other coronaviruses play a role in severe disease development.
Study design:
Prospective open label clinical observational study. In this study samples will be collected from 150 COVI-19 patients ( 50 mild (group 1), 50 severe (group 2) and 50 very severe (group 3) ). Blood, nasal brushes and stool will be collected for all groups at hospital admission and 3 months after recovery, and for groups 2 \& 3 at day 3, at day 14, and before detubation. Study subjects will be retrospectively allocated to the groups.
Study population:
A total of 150 patients diagnosed with COVID-19 will be included. The investigators aim for 50 patients per group, divided over 3 groups:
Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization.
Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care.
Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.
Main study parameters/endpoints:
The primary endpoint of this study is the identification of genes, pathways and cell populations that associate with clinical outcome and disease progression in mild, severe and very severe COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild COVID-19 | – | –Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. |
| Severe COVID-19 | – | –Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. |
| Very Severe COVID-19 | – | –Patients with very severe disease admitted to intensive care, who require mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 Patients with mild disease who tested positively for SARS-CoV2 infection, but only experience mild symptoms and do not need hospitalization. Group 2 Patients with severe disease admitted to hospital, without the need to be admitted to the intensive care. Group 3 Patients with very severe disease admitted to intensive care, who require mechanical ventilation.
Key inclusion criteria (2 listed)
- Patients have to be tested (PCR) positive for SARS-CoV2 infection.
- Provided written informed consent
Key exclusion criteria (1 listed)
- 1. No comprehension of Dutch or English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasal epithelial transcriptional response to SARS-CoV2
Time frame: Observational-baseline
To assess how the nasal epithelial transcriptional response to SARS-CoV2 is different in patients with mild, severe, or very severe disease.
1 secondary outcome
ACE2-AngII system
Time frame: Observational-baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided. Data can be shared on request.
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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.
Dirk-Jan Slebos, MD PhD principal investigator
UMCG, Department of pulmonology
Janesh Pillay, MD PhD principal investigator
UMCG, Intensive Care Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Medical Center Groningen.
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 1 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: withdrawn, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Nasal epithelial transcriptional response to SARS-CoV2 (time frame: Observational-baseline). 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 4 Nov 2022.