SARS-CoV-2 InfectionCOV-CREMNCT04365322
Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)
An observational study of SARS-CoV-2 Infection, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Additional biological samples
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2020to 20 Apr 2025
- How long will I take part?
- 5 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with COVID-19 or convalescent.
Who may be able to join
- COVID-19 PCR positive,
- Hospitalized patients with illness of any duration, and/or SpO2 ≤ 92% on room air.
- Cohorte C : patients with cancer (hematological malignancies and solid tumors).
Who cannot join
- Refusal to participate,
- Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study,
- Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus,
- Active autoimmune disease that required a systemic treatment, with the following exceptions:
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,
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- Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
- Patients currently exposed to chemotherapy, anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy or biotherapy (except for patients in cohort C),
- Previous prescribing of biotherapy or treatment for the management of COVID-19 is not an exclusion criterion,
- Patient under guardianship, curatorship or under the protection of justice.
Trial locations and contacts
1 site in 1 country.
Kevin BOUILLER, MD contact
France1 site, 1 recruiting
- Recruiting
CHU Jean Minjoz
Besançon, 25030
Marie KROEMER, PharmD PhD, mkroemer@chu-besancon.fr
Kevin BOUILLER, MD, kbouiller@chu-besancon.fr
About this study
Official title: Étude Des réponses Immunitaires Lymphocytaires spécifiques Chez Des Patients infectés Par le Virus SARS-CoV-2 : Caractéristiques Des Réponses Effectrices et Mémoires
SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Additional biological samples
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biological samplesOther
Also called Additional blood samples will be realized as part of the care
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Severe COVID-19 infection | Not described Receives: Other: Additional biological samples | |
| Light to moderate COVID-19 infection | Not described Receives: Other: Additional biological samples | |
| Cancer patients with COVID-19 infection | Not described Receives: Other: Additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific immune responses
Intensity and diversity of immune responses specific for SARS-COV-2
Measured: During COVID-19 infection or one month after COVID-19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start20 Apr 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 160 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365322
- Sponsor's protocol ID
- 2020/502
- Acronym
- COV-CREM
- Status last verified
- May 2020
- First submitted
- 25 Apr 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Des réponses Immunitaires Lymphocytaires spécifiques Chez Des Patients infectés Par le Virus SARS-CoV-2 : Caractéristiques Des Réponses Effectrices et Mémoires
- ClinicalTrials.gov ID
- NCT04365322
- Acronym / sponsor ID
- COV-CREM / 2020/502
- Conditions
- SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 28 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.
SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe COVID-19 infection | – | Other: Additional biological samples |
| Light to moderate COVID-19 infection | – | Other: Additional biological samples |
| Cancer patients with COVID-19 infection | – | Other: Additional biological samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 or convalescent.
Key inclusion criteria (3 listed)
- COVID-19 PCR positive,
- Hospitalized patients with illness of any duration, and/or SpO2 ≤ 92% on room air.
- Cohorte C : patients with cancer (hematological malignancies and solid tumors).
Key exclusion criteria (10 listed)
- Refusal to participate,
- Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study,
- Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus,
- Active autoimmune disease that required a systemic treatment, with the following exceptions:
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
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 |
|---|---|---|
| Additional biological samplesAlso: Additional blood samples will be realized as part of the carePeripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. | Other | Cancer patients with COVID-19 infection, Light to moderate COVID-19 infection, Severe COVID-19 infection |
Primary outcome
Specific immune responses
Time frame: During COVID-19 infection or one month after COVID-19 infection
Intensity and diversity of immune responses specific for SARS-COV-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
Kevin BOUILLER, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection, run by Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 10 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 14 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie KROEMER, PharmD PhD (0370632281, mkroemer@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific immune responses (time frame: During COVID-19 infection or one month after COVID-19 infection). 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 14 Jul 2020.