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Human Ab Response & immunoMONItoring of COVID-19 Patients (HARMONICOV)

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ClinicalTrials.gov Identifier: NCT04373200
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Coronavirus Acute Respiratory Distress Syndrome Biological: Blood samples collection Other: Saliva collection Not Applicable

Detailed Description:

Assessed by World Health Organisation as a pandemic on March 11, COVID-19 is caused by the SARS-CoV-2 coronavirus. The spectrum of its clinical manifestations is strikingly broad and extends from mild disease (resembling an ordinary bout of flu or even asymptomatic) to pneumonia. The latter cases convey a high risk of evolution towards acute respiratory distress syndrome (ARDS), eventually fatal when worsening with cytokine storm and multiple organ failure or with superinfection and sepsis. In the absence of overt variations of the virus itself, its interactions with the host immune system are likely crucial. Clinical features of patients with severe forms of COVID-19 were reported, but immunological description of biomarkers for exacerbation and mortality vs recovery remains superficial. Globally decreased white blood cells, notably T-cells, suggest that CoV-2 might trigger or exploit an immune defect. This could correspond to gaps in immune cell subpopulations, kinetics of activation or repertoires. Immune failure would then be responsible for exacerbations and a poor outcome in intensive care unit (ICU) patients. The objective of the study is to characterize the kinetics of the immune response and of immune dysregulation in ARDS patients. In addition to studying severe ARDS patients, an inverse image of immune repertoires should appear in healed up patients, after they have reached an undetectable viral load and acquired protective antibodies (Abs). Humoral immunity mediated by specific anti-viral Abs was a key factor for recovery from SARS-CoV-1 infection, and this is also expected for CoV-2, making the Ig repertoire also of special interest for its inclusion of anti-viral neutralizing Abs (nAbs).

Altogether, there is thus an urgent need for high-resolution characterization of the anti-CoV-2 immune response, correlating the dynamics of immune activation, cytokine production and immune repertoires with clinical evolution. In addition to providing biomarkers for prognosis evaluation and for monitoring innovative treatments this will also participate to the urgent quest of as many possible monoclonal antibodies (mAb) candidates for immunotherapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Human Ab Response & immunoMONItoring of COVID-19 Patients
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : November 25, 2020


Arm Intervention/treatment
Experimental: COVID-19 patients with associated ARDS Biological: Blood samples collection
Blood sample collection at Day 1, day 7, day 14 for all patients. At month 4 for 25 survivors COVID-19 patients

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

Active Comparator: COVID-19 patients without associated ARDS Biological: Blood samples collection
Blood sample collection at Day 1, day 7, day 14 for all patients. At month 4 for 25 survivors COVID-19 patients

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

Active Comparator: Patients with ARDS from other causes Biological: Blood samples collection
Blood sample collection at Day 1, day 7, day 14 for all patients. At month 4 for 25 survivors COVID-19 patients




Primary Outcome Measures :
  1. Number of increased immune population [ Time Frame: Month 4 ]
    Blood sample

  2. Number of decreased immune population [ Time Frame: Month 4 ]
    Blood sample

  3. Number of statically different phenotypes compared to control patients [ Time Frame: Month 4 ]
    Blood sample


Secondary Outcome Measures :
  1. Gain or loss of functional phenotypic markers between D1 and D14 [ Time Frame: Day 14 ]
    Qualitative identification of immune subpopulations showing a significant variation compared to controls and quantification of this variation (at D1 and/or D14)

  2. Gain or loss of functional phenotypic markers between between acute and mild infections [ Time Frame: Day 14 ]
    Qualitative identification of immune subpopulations showing a significant variation between acute and mild COVID-19 and quantification of this variation (at D1 and/or D14)

  3. Gain or loss of functional phenotypic markers between D1 and month 4 [ Time Frame: Month 4 ]
    Qualitative identification of immune subpopulations showing a significant variation between acute stage and recovery (at 4 months) and quantification of this variation

  4. Evaluation of V, D, J gene usage alterations in the immunoglobulin and T cell receptor (TCR) repertoires during ARDS linked to COVID-19 [ Time Frame: Day 14 ]
    Blood sample

  5. Identification of the Ig classes and of V, D, J sequences of anti-CoV-2 antibodies [ Time Frame: Month 4 ]
    Blood sample

  6. Characterization of a new set of human antibodies from patients who have recovered of COVID-19 [ Time Frame: Month 4 ]
    Blood sample



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT04373200


Contacts
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Contact: Florian REIZINE, MD 02 99 28 42 48 florian.reizine@chu-rennes.fr

Locations
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France
CHU Rennes Recruiting
Rennes, France, 35033
Contact: Florian REIZINE, MD       florian.reizine@chu-rennes.fr   
Sub-Investigator: Jean-Marc TADIE, MD, PhD         
Sub-Investigator: Mathieu LESOUHAITIER, MD         
Sub-Investigator: Karin TARTE, MD, PhD         
Sub-Investigator: Michel COGNE, MD, PhD         
Sub-Investigator: Mikaël ROUSSEL, MD         
Sub-Investigator: Isabelle GOUIN, MD         
Sub-Investigator: Alexandre MANSOUR, MD         
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04373200    
Other Study ID Numbers: 35RC20_9795_HARMONICOV
2020-A01100-39 ( Other Identifier: ANSM (N°ID-RCB) )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
COVID-19
SARS-CoV-2 coronavirus
Acute Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Coronavirus Infections
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Injury