Human Ab Response & immunoMONItoring of COVID-19 Patients

NCT04373200 | Completed

• 2 other identifiers: 35RC20_9795_HARMONICOV2020-A01100-39
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, mono centric study on COVID-19 patients with or without acute respiratory distress syndrome (ARDS) to analyse the dynamics of the immune response and to search for biomarkers of evolution

Conditions

SARS-CoV-2 Coronavirus; Acute Respiratory Distress Syndrome

Keywords

COVID-19; SARS-CoV-2 coronavirus; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (3)

• Number of increased immune population

  Blood sample

  Month 4

• Number of decreased immune population

  Blood sample

  Month 4

• Number of statically different phenotypes compared to control patients

  Blood sample

  Month 4

Secondary Outcomes (6)

• Gain or loss of functional phenotypic markers between D1 and D14

  Day 14

• Gain or loss of functional phenotypic markers between between acute and mild infections

  Day 14

• Gain or loss of functional phenotypic markers between D1 and month 4

  Month 4

• Evaluation of V, D, J gene usage alterations in the immunoglobulin and T cell receptor (TCR) repertoires during ARDS linked to COVID-19

  Day 14

• Identification of the Ig classes and of V, D, J sequences of anti-CoV-2 antibodies

  Month 4

Study Arms (3)

COVID-19 patients with associated ARDS

EXPERIMENTAL

Biological: Blood samples collection; Other: Saliva collection

COVID-19 patients without associated ARDS

ACTIVE COMPARATOR

Biological: Blood samples collection; Other: Saliva collection

Patients with ARDS from other causes

ACTIVE COMPARATOR

Biological: Blood samples collection

Interventions

Blood samples collection BIOLOGICAL

Blood sample collection at Day 1, day 7, day 14 for all patients. At month 4 for 25 survivors COVID-19 patients

COVID-19 patients with associated ARDS; COVID-19 patients without associated ARDS; Patients with ARDS from other causes

Saliva collection OTHER

Saliva collection at Month 4 for 25 survivors COVID-19 patients

COVID-19 patients with associated ARDS; COVID-19 patients without associated ARDS

Eligibility Criteria

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

You may qualify if:

• Patient older than 18 years old
• Patients COVID-19 :
• hospitalized for less than 48 hours in intensive care unit (ICU) with ARDS (PaO2/Fi02 \< 200) or
• hospitalized with respiratory syndrome without need of invasive mechanical ventilation
• Patients hospitalized for less than 48 hours in intensive care unit (ICU) with ARDS (PaO2/Fi02 \< 200) from other causes
• Patients who have given their consent or included in an emergency situation
• Patients affiliated to medical care insurance

You may not qualify if:

• Pregnant women
• Preexisting immune disorders (HIV-infection, malignancy, graft, treatment with immunosuppressive agents)
• Patients legally protected (under judicial protection, guardianship), persons deprived of liberty

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, 35033, France

Location

Related Publications (3)

• Pascal V, Dupont M, de Rouault P, Rizzo D, Rossille D, Jeannet R, Daix T, Francois B, Genebrier S, Cornic M, Monneret G, Venet F, Ferrant J, Roussel M, Reizine F, Le Souhaitier M, Tadie JM, Tarte K, Feuillard J, Cogne M. Demultiplexing Ig repertoires by parallel mRNA/DNA sequencing shows major differential alterations in severe COVID-19. iScience. 2023 Mar 17;26(3):106260. doi: 10.1016/j.isci.2023.106260. Epub 2023 Feb 21.

  PMID: 36845033 RESULT

• Roussel M, Ferrant J, Reizine F, Le Gallou S, Dulong J, Carl S, Lesouhaitier M, Gregoire M, Bescher N, Verdy C, Latour M, Bezier I, Cornic M, Vinit A, Monvoisin C, Sawitzki B, Leonard S, Paul S, Feuillard J, Jeannet R, Daix T, Tiwari VK, Tadie JM, Cogne M, Tarte K. Comparative immune profiling of acute respiratory distress syndrome patients with or without SARS-CoV-2 infection. Cell Rep Med. 2021 Jun 15;2(6):100291. doi: 10.1016/j.xcrm.2021.100291. Epub 2021 May 6.

  PMID: 33977279 RESULT

• Hamzeh-Cognasse H, Mansour A, Reizine F, Mismetti P, Gouin-Thibault I, Cognasse F. Platelet-derived sCD40L: specific inflammatory marker for early-stage severe acute respiratory syndrome coronavirus 2 infection. Virol J. 2021 Oct 29;18(1):211. doi: 10.1186/s12985-021-01680-3.

  PMID: 34715884 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Comparative study with 3 cohorts of 25 adult patients: * Cohort A: 25 COVID-19 associated ARDS * Cohort B: 25 COVID-19 without ARDS * Cohort C: 25 ARDS from other causes

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 4, 2020
• Study Start: May 25, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

FR (1)