CClinicalTrials.gg
RecruitingNCT04365322COV-CREMUpdated Jul 14, 2020

Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)

An observational study in SARS-CoV-2 Infection, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2020, 6 years 1 month ago, but the record still lists the study as recruiting.
  • Started Apr 2020; still recruiting 6 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • SARS-CoV-2 Infection

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 160 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with COVID-19 or convalescent.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • OtherAdditional biological samples

    Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.

    Also known as: Additional blood samples will be realized as part of the care

06

What researchers measure

Primary outcomes

  1. Specific immune responses

    Intensity and diversity of immune responses specific for SARS-COV-2

    Time frame: During COVID-19 infection or one month after COVID-19 infection

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04365322
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Apr 28, 2020
Start date
Apr 20, 2020
Primary completion
Sep 1, 2020 (estimated)
Completion
Apr 20, 2025 (estimated)
Last update
Jul 14, 2020

Study contacts

Marie KROEMER, PharmD PhD
Contact
mkroemer@chu-besancon.fr
0370632281
Kevin BOUILLER, MD
Contact
kbouiller@chu-besancon.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion