Covid-19NCT04363385
Collection of Biological Samples With Clinical Characterization of Covid-19 Patients
A study testing Biological test in people with Covid-19, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Biological collection (blood sample) associated with clinical data from Covid-19 patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19
- What is being tested?
- Biological test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2020to 31 May 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of COVID-19 confirmed on RT-PCR test or chest scanner
- Any age
- Membership in the general social security system
- Inform consent signed by the patient or by legal representatives for minors
Who cannot join
- Refusal of the patient or one of the legal representatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort of Patients With Covid19: Constitution of Blood Samples Collections With Clinical Characterization
Biological collection (blood sample) associated with clinical data from Covid-19 patients
Read the detailed description
SARS-Cov2 is an emerging respiratory virus in the coronavirus family, responsible of the pandemic since November 2019. France, which has more than 17,000 deaths from the virus, is one of the main outbreaks. As of 16 April 2020, more than 76,000 individuals in France have been hospitalized, corresponding to 69% of confirmed cases (https://www.santepubliquefrance.fr).
Most affected patients have more or less marked clinical signs associating fever, cough, dyspnea, myalgia, anosmia, ageusia, digestive disorders. In some cases, the progression is worse with lung disease of varying severity. Indications for hospitalization are essentially the severe forms of Covid-19 disease, characterized by hypoxemic lung disease.
Risk factors for developing severe Covid-19 disease have been identified already: age, co-morbidity such as diabetes, obesity-overweight or cardiovascular diseases. It is assumed that other host-related factors, including genetics, may contribute to the existence of this phenotypic heterogeneity. At present, these factors are not known.
The objective of this research is to constitute a DNA collection from patients with Covid-19, in order to be able to search for genetic factors modulating the clinical phenotype.
- Conditions
- Covid-19
- Being tested
- Biological test
- Keywords
- Blood samples, ADN, ARN, plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological testBiological
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Collection of blood sample | Other | Not described Receives: Biological: Biological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype/genotype correlation research modulating the severity of Covid-19 disease
Clinical aggravation markers (admission in intensive care)
Measured: Anytime in the period of 10 years
Secondary outcomes (8)
Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease
Severity at the Covid-19 Lung Scanner
Measured: Anytime in the period of 10 years
Phenotype/biomarker correlation research modulating the severity of Covid-19 disease
Severity at the Covid-19 Lung Scanner
Measured: Anytime in the period of 10 years
Development of clinical-biological scores in the severity of Covid-19 disease
Evolution of scanographic lesions or pulmonary ultrasound
Measured: Anytime in the period of 10 years
Development of predictive imaging scores in the severity of Covid-19 disease
Evolution of scanographic lesions or pulmonary ultrasound
Measured: Anytime in the period of 10 years
Identification of pathophysiological pathways to susceptibility to Covid-19 disease
Duration of oxygen therapy, artificial ventilation
Measured: Anytime in the period of 10 years
Identification of genetic markers for treatment response
Genome sequencing
Measured: Anytime in the period of 10 years
Identification of transcriptomic markers for treatment response
Sequencing transcriptome
Measured: Anytime in the period of 10 years
Identification of proteomic for treatment response
Proteomic sequencing
Measured: Anytime in the period of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start31 May 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: No more inclusion
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Collection of blood samples in a cohort of Covid-19 patients
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363385
- Sponsor's protocol ID
- COVIGENET
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With Covid19: Constitution of Blood Samples Collections With Clinical Characterization
- ClinicalTrials.gov ID
- NCT04363385
- Acronym / sponsor ID
- COVIGENET
- Conditions
- Covid-19
- Keywords
- Blood samples, ADN, ARN, plasma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more inclusion
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 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.
Biological collection (blood sample) associated with clinical data from Covid-19 patients
Detailed description
SARS-Cov2 is an emerging respiratory virus in the coronavirus family, responsible of the pandemic since November 2019. France, which has more than 17,000 deaths from the virus, is one of the main outbreaks. As of 16 April 2020, more than 76,000 individuals in France have been hospitalized, corresponding to 69% of confirmed cases (https://www.santepubliquefrance.fr).
Most affected patients have more or less marked clinical signs associating fever, cough, dyspnea, myalgia, anosmia, ageusia, digestive disorders. In some cases, the progression is worse with lung disease of varying severity. Indications for hospitalization are essentially the severe forms of Covid-19 disease, characterized by hypoxemic lung disease.
Risk factors for developing severe Covid-19 disease have been identified already: age, co-morbidity such as diabetes, obesity-overweight or cardiovascular diseases. It is assumed that other host-related factors, including genetics, may contribute to the existence of this phenotypic heterogeneity. At present, these factors are not known.
The objective of this research is to constitute a DNA collection from patients with Covid-19, in order to be able to search for genetic factors modulating the clinical phenotype.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Collection of blood samples in a cohort of Covid-19 patients
| Arm | Type | Receives |
|---|---|---|
| Collection of blood sample | Other | Biological: Biological test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COVID-19 confirmed on RT-PCR test or chest scanner
- Any age
- Membership in the general social security system
- Inform consent signed by the patient or by legal representatives for minors
Key exclusion criteria (1 listed)
- Refusal of the patient or one of the legal representatives
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 |
|---|---|---|
| Biological testBlood sample | Biological | Collection of blood sample |
Primary outcome
Phenotype/genotype correlation research modulating the severity of Covid-19 disease
Time frame: Anytime in the period of 10 years
Clinical aggravation markers (admission in intensive care)
8 secondary outcomes
Phenotype/transcriptomic correlation research modulating the severity of Covid-19 disease
Time frame: Anytime in the period of 10 years
Phenotype/biomarker correlation research modulating the severity of Covid-19 disease
Time frame: Anytime in the period of 10 years
Development of clinical-biological scores in the severity of Covid-19 disease
Time frame: Anytime in the period of 10 years
Development of predictive imaging scores in the severity of Covid-19 disease
Time frame: Anytime in the period of 10 years
Identification of pathophysiological pathways to susceptibility to Covid-19 disease
Time frame: Anytime in the period of 10 years
Identification of genetic markers for treatment response
Time frame: Anytime in the period of 10 years
Identification of transcriptomic markers for treatment response
Time frame: Anytime in the period of 10 years
Identification of proteomic for treatment response
Time frame: Anytime in the period of 10 years
Results and safety
The study was stopped early (reason given: No more inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological test in people with Covid-19, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study was stopped early (reason given: No more inclusion). 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?
Phenotype/genotype correlation research modulating the severity of Covid-19 disease (time frame: Anytime in the period of 10 years). 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 12 Apr 2024.