Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19

NCT04379466 | Completed

• 2 other identifiers: APHP2005442020-A01245-34
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The specificity of the adaptive immune response (AIR), and its balance between effector T cells (Teffs) and regulatory T cells (Tregs), is most likely a major determinant of the outcome of a Covid-19 infection. We aim to analyze (i) the cellular components and (ii) the specificity of the AIR to COVID-19 in 60 patients with moderate and severe form of the disease. This should have important implications for (i) understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and (iii) designing treatments and vaccines.

Conditions

COVID-19

Keywords

COVID-19; T cell receptor; Effector T cells; Regulatory T cells; Single cell sequencing; Modelisation; Pathophysiology; Biomarkers

Outcome Measures

Primary Outcomes (1)

• A list of COVID-19 specific TCR sequences

  at day1

Secondary Outcomes (2)

• One or more measures from peripheral blood immunophenotyping that is/are associated with COVID-19 outcome

  at day1

• Group of COVID-19 specific TCR sequences that is associated with COVID-19 outcome

  at day1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men or women, aged 18 to 75, infected with SARS-CoV-2 and admitted to the Pitié-Salpêtrière hospital for treatment

You may qualify if:

• Age≥18 and ≤75 years
• Presenting a confirmed diagnosis of COVID-19 disease in accordance with WHO diagnostic criteria;
• Good venous capital ;
• Affiliation to a social security system;
• Having declared his/her non-opposition to participation in research (for patients hospitalized in intensive care units who are not able to communicate, the non-opposition of a trusted person will be sought.)

You may not qualify if:

• Psychiatric illness or addiction that could interfere with the ability to comply with the requirements of the protocol or to give consent to participate in the study;
• Patient benefiting from a legal protection measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitie Salpétrère

Paris, 75013, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David KLATZMANN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 11, 2020
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

FR (1)