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Study of Immune Response During SARS-CoV-2 Infection - (COVID-19) (CovImmune)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355351
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response.

The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1


Condition or disease Intervention/treatment Phase
New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2 Other: blood sampling Other: additional blood tubes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Immune Response During SARS-CoV-2 Infection
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : October 22, 2020
Estimated Study Completion Date : October 22, 2020

Arm Intervention/treatment
hospital staff exposed to SARS-Cov-2 Other: blood sampling
blood sampling done on hospital staff without sars-coV-2 symptoms

SARS-Cov-2 infected patient Other: additional blood tubes
Additionnal blood tube taken during the classical blood sampling in hospital




Primary Outcome Measures :
  1. Level of IFN-gamma after a non-specific stimulation of T lymphocytes [ Time Frame: 6 months ]
    Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

1/ Medical personnel exposed to SARS-CoV-2 infection

Inclusion criteria:

  • Every willing member of medical personnel who is in charge of care, treatment or transfer of patients with COVID-19, in the hospitals of Nice, Cannes and Antibes
  • The absence of infection with SARS-CoV-2 at enrolment
  • Age > 18 years
  • Having signed an informed consent
  • Valid health insurance

Non-inclusion criteria:

  • Age < 18 years
  • Under custody, in prison or diagnosed with a mental illness
  • Refusal to give informed consent or its withdrawal
  • Pregnant or breastfeeding
  • Known immunodeficiency
  • Previous immunosuppressive therapy

    2) Subjects hospitalized for a SARS-CoV-2 infection

Inclusion criteria:

  • All adult patients hospitalized in the intensive care or in infectious diseases units, or receiving follow-up at the dermatology unit, in Nice University Hospital, diagnosed with COVID-19 (as defined by the positivity to SARS-CoV-2 by two PCR multiplex)
  • Age > 18 years
  • Having signed an informed consent

Non-inclusion criteria:

  • Age < 18 years
  • Under custody, in prison or diagnosed with a mental illness
  • Refusal to give informed consent or its withdrawal
  • Pregnant or breastfeeding
  • Known immunodeficiency
  • Previous immunosuppressive therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355351


Contacts
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Contact: Barbara SEITZ-POLSKI, MCUPH 33 4 92 03 55 02 seitz-polski.b@chu-nice.fr

Locations
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France
Antibes Hospital Recruiting
Antibes, France
Contact: sonia BOYER-SUAVET, PH       soniaboyer@hotmail.fr   
Cannes Hospital Recruiting
Cannes, France
Contact: Matteo VASSALLO, PH       M.VASSALLO@ch-cannes.fr   
Nice Hospital Recruiting
Nice, France, 06000
Contact: Barbara SEITZ-POLSKI, MCUPH    33 4 92 03 55 02    seitz-polski.b@chu-nice.fr   
Sub-Investigator: Jean DELLAMONICA, PUPH         
Sub-Investigator: elisa DEMONCHY, PH         
Sub-Investigator: johanna PLANCHARD, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04355351    
Other Study ID Numbers: 20-PP-05
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases