NCT04355351

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

May 5, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

April 17, 2020

Last Update Submit

May 16, 2024

Conditions

New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Level of IFN-gamma after a non-specific stimulation of T lymphocytes

    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.

    6 months

Study Arms (2)

hospital staff exposed to SARS-Cov-2

OTHER
Other: blood sampling

SARS-Cov-2 infected patient

OTHER
Other: additional blood tubes

Interventions

blood samplingOTHER

blood sampling done on hospital staff without sars-coV-2 symptoms

hospital staff exposed to SARS-Cov-2
additional blood tubesOTHER

Additionnal blood tube taken during the classical blood sampling in hospital

SARS-Cov-2 infected patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • \) Subjects hospitalized for a SARS-CoV-2 infection
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Antibes Hospital

Antibes, France

Location

Cannes Hospital

Cannes, France

Location

Nice Hospital

Nice, 06000, France

Location

Related Publications (1)

  • Buscot M, Cremoni M, Graca D, Brglez V, Courjon J, Allouche J, Teisseyre M, Boyer L, Barriere J, Chamorey E, Carles M, Seitz-Polski B. Breakthrough infections due to SARS-CoV-2 Delta variant: relation to humoral and cellular vaccine responses. Front Immunol. 2023 Mar 30;14:1145652. doi: 10.3389/fimmu.2023.1145652. eCollection 2023.

    PMID: 37063916DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

May 5, 2020

Primary Completion

December 4, 2021

Study Completion

June 22, 2022

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)