Predictive Immune Biomarkers for COVID-19 Pathogenesis

NCT04385108 | Completed DMC

• 1 other identifier: RC31/20/0162
• Study Type: interventional
• Target: 565
• Locations: 1 country
• Sites: 1

Brief Summary

The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.

Conditions

COVID-19

Keywords

SARS-CoV-2; COVID-19; predictive medicine; pathophysiology; immune responses

Outcome Measures

Primary Outcomes (2)

• Immune signature

  Analysis of the phenotypic profiling of blood T-cells by multicolor fluorescence-activated cell sorter (FACS) analysis assessing T cell subsets through the expression of a wide range of surface and intracellular markers

  Day 0

• Dosage of cytokines and chemokines in plasma samples

  Analysis on plasma samples of a wide range of cytokines and chemokines using multiplex

  Day 0

Secondary Outcomes (11)

• Immune signature

  Day 2

• Immune signature

  Day 4

• Immune signature

  Day 8

• Immune signature

  Day 12

• Immune signature

  Day 30 (or in discharge)

Study Arms (2)

hospitalized patients

EXPERIMENTAL

very well-defined population of COVID-19 patients with the following outcomes: * Patients with severe disease requiring on admission ICU management for ARDS, * Non-severe hospitalized patients with secondary clinical worsening requiring ICU management, * Non-severe hospitalized patients without clinical worsening requiring ICU management.

Biological: Blood collection on admission and longitudinally

healthcare workers

EXPERIMENTAL

mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited

Biological: Blood collection on their first consultation and 10 to 14 days later

Interventions

Blood collection on admission and longitudinally BIOLOGICAL

33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)

hospitalized patients

Blood collection on their first consultation and 10 to 14 days later BIOLOGICAL

33 mL of blood collected on their first consultation and 10 to 14 days later

healthcare workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For COVID-19 hospitalized patients
• Polymerase chain reaction (PCR) proven SARS-CoV-2 infection
• Participation to Toulouse clinical cohort
• For COVID-19 healthcare workers attending dedicated clinics
• PCR proven SARS-CoV-2 infection

You may not qualify if:

• Pregnancy or breastfeeding
• Participation in another interventional clinical study involving exploratory treatment or blood sampling.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Purpan University Hospital

Toulouse, 31059, France

Location

Related Publications (3)

• Dimeglio C, Herin F, Da-Silva I, Gernigon C, Porcheron M, Chapuy-Regaud S, Izopet J. Decreased Efficiency of Neutralizing Antibodies from Previously Infected or Vaccinated Individuals against the B.1.617.2 (Delta) SARS-CoV-2 Variant. Microbiol Spectr. 2022 Aug 31;10(4):e0270621. doi: 10.1128/spectrum.02706-21. Epub 2022 Jul 5.

  PMID: 35867411 DERIVED

• Dimeglio C, Herin F, Da-Silva I, Jougla I, Pradere C, Porcheron M, Martin-Blondel G, Chapuy-Regaud S, Izopet J. Heterologous ChAdOx1-S/BNT162b2 Vaccination: Neutralizing Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2022 Apr 9;74(7):1315-1316. doi: 10.1093/cid/ciab705. No abstract available.

  PMID: 34383902 DERIVED

• Kreutmair S, Unger S, Nunez NG, Ingelfinger F, Alberti C, De Feo D, Krishnarajah S, Kauffmann M, Friebel E, Babaei S, Gaborit B, Lutz M, Jurado NP, Malek NP, Goepel S, Rosenberger P, Haberle HA, Ayoub I, Al-Hajj S, Nilsson J, Claassen M, Liblau R, Martin-Blondel G, Bitzer M, Roquilly A, Becher B. Distinct immunological signatures discriminate severe COVID-19 from non-SARS-CoV-2-driven critical pneumonia. Immunity. 2021 Jul 13;54(7):1578-1593.e5. doi: 10.1016/j.immuni.2021.05.002. Epub 2021 May 9.

  PMID: 34051147 DERIVED

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

• Guillaume MARTIN-BLONDEL, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

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: May 5, 2020
• First Posted: May 12, 2020
• Study Start: March 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 24, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)