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Host-pathogen Interactions During SARS-CoV-2 Infection (HPI-COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04376476
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.

In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.

Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.

In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.


Condition or disease Intervention/treatment Phase
Infection, Coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 Biological: Blood sample Biological: Low or upper respiratory tract sample Biological: Stool collection or fecal swab Genetic: Blood sample for whole genome sequencing Other: phone call Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : June 5, 2021
Estimated Study Completion Date : June 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adult group A1
Adults with confirmed pauci-symptomatic COVID-19 infection recruited through the blood collection centers set up by the occupational health services. Hospital visits (for clinical examination, biology, immunology, virology measurements) are scheduled at day 0, day 3, day 7, day 14, day 21; phone call is scheduled at day 10.
Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Biological: Low or upper respiratory tract sample

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0


Biological: Stool collection or fecal swab

The stool collection or fecal swab will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0


Genetic: Blood sample for whole genome sequencing
The blood sample for whole genome sequencing will be performed at day 0 for group A1 and A2.

Other: phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14

Experimental: Adult group A2
Adults with confirmed COVID-19 infection of moderate clinical severity recruited within participating units. Follow-up visits (for clinical examination, biology, immunology, virology measurements) are scheduled at day 0, day 3, day 7, day 14, day 21, and in case of worsening; a day 10 visit will be performed by phone or onsite if the patient is still hospitalized.
Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Biological: Low or upper respiratory tract sample

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0


Biological: Stool collection or fecal swab

The stool collection or fecal swab will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0


Genetic: Blood sample for whole genome sequencing
The blood sample for whole genome sequencing will be performed at day 0 for group A1 and A2.

Other: phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14

Experimental: Adult group A3
Adults with confirmed non-COVID-19 viral infection pauci-symptomatic recruited through the blood collection centers set up by the occupational health services. Hospital visits (for clinical examination, biology, immunology, virology measurements) are scheduled at day 0, day 3, day 7, day 14, day 21; phone call is scheduled at day 10.
Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Biological: Low or upper respiratory tract sample

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0


Biological: Stool collection or fecal swab

The stool collection or fecal swab will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0


Other: phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14

Experimental: Children group E1
Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Biological: Low or upper respiratory tract sample

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0


Other: phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14

Experimental: Children group E2
Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized).
Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Biological: Low or upper respiratory tract sample

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0


Biological: Stool collection or fecal swab

The stool collection or fecal swab will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0


Experimental: Children group E3
Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
Biological: Blood sample
blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0

Biological: Low or upper respiratory tract sample

Low or upper respiratory tract sample will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0


Biological: Stool collection or fecal swab

The stool collection or fecal swab will be collected in order to take virology measurements:

Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0


Other: phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14




Primary Outcome Measures :
  1. Initial biological profile of children and adults with COVID-19 infection [ Time Frame: Day 0 ]

    Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation

    measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.


  2. Initial immunological profile of children and adults with COVID-19 infection [ Time Frame: Day 0 ]
    measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.


Secondary Outcome Measures :
  1. Clinical worsening [ Time Frame: Within 21 days following inclusion ]
    Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection

  2. Evolution of the immunological profile of children and adults with COVID-19 [ Time Frame: Within 21 days following inclusion ]
    measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening

  3. Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 [ Time Frame: Day 0 ]
    Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation

  4. titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 [ Time Frame: Day 0 ]
    Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation

  5. titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19 [ Time Frame: Day 0 ]
    Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation

  6. Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19 [ Time Frame: Within 21 days following inclusion ]
    Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening

  7. titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19 [ Time Frame: Within 21 days following inclusion ]
    Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

  8. titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19 [ Time Frame: Within 21 days following inclusion ]
    Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

  9. Genetic profile of adults with COVID-19 infection [ Time Frame: Day 0 ]
    Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.

  10. Genetic profile of adults with COVID-19 infection [ Time Frame: Within 21 days following inclusion ]
    Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Group A1:

  • Age ≥ 18 years and ≤ 70 years;
  • Infection with the SARS-CoV-2 virus confirmed by Reverse transcription polymerase chain reaction (RT-PCR) on a upper or low respiratory tract sample
  • Clinical evolution ≤ 5 days at inclusion;
  • No hospitalization criteria (National Early Warning Score (NEWS-2 score) ≤ 4);
  • No risk factor for serious outcome;
  • Absence of therapeutic limitation decided a priori (level of care = 1);
  • Patients having been informed of the study, not objecting to participating in it and having signed the consent;
  • Beneficiary of a social security scheme.

Group A2:

  • Age ≥ 18 years and ≤ 70 years;
  • Infection with the SARS-CoV-2 virus confirmed by RT-PCR on a upper or low respiratory tract sample
  • Clinical evolution ≤ 5 days at inclusion;
  • Hospitalization in medical unit with oxygen dependence (need for oxygen to reach an peripheral oxygen saturation (SpO2) ≥ 94%) but flow ≤ 3 liter/minute (L / min);
  • Absence of therapeutic limitation decided a priori (level of care = 1);
  • Patients having been informed of the study, not objecting to participating in it and having signed the consent;
  • Beneficiary of a social security scheme.

Group A3:

  • Age ≥ 18 years and ≤ 70 years;
  • Negative SARS-CoV-2 PCR on at least one respiratory sample, and other confirmed viral infection
  • Clinical evolution ≤ 5 days at inclusion;
  • No hospitalization criteria (NEWS-2 score ≤ 4);
  • No risk factor for serious outcome
  • Absence of therapeutic limitation decided a priori (level of care = 1);
  • Patients having been informed of the study, not objecting to participating in it and having signed the consent;
  • Beneficiary of a social security scheme.

Group E1:

  • Age from birth to <18 years old;
  • Weight> 3 kilogram (kg);
  • Infection with SARS-CoV-2 virus confirmed by RT-PCR on upper respiratory tract sample
  • No fever or respiratory symptoms;
  • Not requiring hospitalization;
  • Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
  • Beneficiary of a social security scheme

Group E2:

  • Age from birth to <18 years old;
  • Weight> 3kg;
  • Infection with the SARS-CoV-2 virus confirmed by RT-PCR on a upper or low respiratory tract sample or pneumonia with scanner suggesting SARS-CoV-2 infection;
  • Hospitalized in a pediatric intensive care unit or in a general pediatrics unit
  • Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
  • Beneficiary of a social security scheme

Group E3:

  • Age from birth to <18 years old;
  • Weight> 3 kg;
  • Negative SARS-CoV-2 PCR on at least one respiratory sample, and other confirmed viral infection
  • Hospitalized in a pediatric intensive care unit or in a general pediatrics unit, for a respiratory reason;
  • Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
  • Beneficiary of a social security scheme

Exclusion Criteria:

Group A1:

  • Proven or suspected bacterial or viral co-infection;
  • Presence of a hospitalization criterion: respiratory, neurological or hemodynamic distress (NEWS-2 score > 4);
  • Presence of a serious risk factor
  • Patients treated or going to be treated with an immunomodulator (including interferon);
  • Patients who have received immunosuppressive therapy, biotherapy and / or corticosteroid therapy at a dose greater than 10 milligram per day (mg/d) of prednisone equivalent for more than 2 weeks in the 3 months preceding the virological diagnosis;
  • Patients who have been treated with rituximab;
  • Patients who received systemic anti-cancer chemotherapy for solid tumor or hemopathy in the 6 months preceding the virological diagnosis;
  • Patients with splenectomy or asplenia
  • Infection with the human immunodeficiency virus (HIV);
  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Pregnancy
  • Levels of care ≥ 2 (therapeutic limitation posed a priori, whatever its extent);
  • Patient under legal protection measure or unable to consent to the study.

Group A2:

  • Proven or suspected bacterial or viral co-infection;
  • Patients treated or going to be treated with an immunomodulator (including interferon);
  • Patients who have received immunosuppressive therapy, biotherapy and / or corticosteroid therapy at a dose greater than 10 mg / d of prednisone equivalent for more than 2 weeks in the 3 months preceding the virological diagnosis;
  • Patients who have been treated with rituximab;
  • Patients who received systemic anti-cancer chemotherapy for solid tumor or hemopathy in the 6 months preceding the virological diagnosis;
  • Patients with splenectomy or asplenia
  • Infection with the human immunodeficiency virus (HIV);
  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Pregnancy ;
  • Levels of care ≥ 2 (therapeutic limitation posed a priori, whatever its extent);
  • Patient under legal protection measure or unable to consent to the study

Group A3:

  • Presence of a hospitalization criterion: respiratory, neurological or hemodynamic distress (NEWS-2 score> 4);
  • Presence of a serious risk factor
  • Patients treated or going to be treated with an immunomodulator (including interferon);
  • Patients who have received immunosuppressive therapy, biotherapy and / or corticosteroid therapy at a dose greater than 10 mg / d of prednisone equivalent for more than 2 weeks in the 3 months preceding the virological diagnosis;
  • Patients who have been treated with rituximab;
  • Patients who received systemic anti-cancer chemotherapy for solid tumor or hemopathy in the 6 months preceding the virological diagnosis;
  • Patients with splenectomy or asplenia
  • Infection with the human immunodeficiency virus (HIV);
  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Pregnancy ;
  • Levels of care ≥ 2 (therapeutic limitation posed a priori, whatever its extent);
  • Patient under legal protection measure or unable to consent to the study

Group E1:

  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Pregnancy.

Group E2:

  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Pregnancy.

Group E3:

  • Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
  • Infection with the SARS-CoV-2 virus known among the relatives
  • Pregnancy.

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): NCT04376476


Contacts
Layout table for location contacts
Contact: Florent VALOUR, PhD 0472 071 107 ext +33 florent.valour@chu-lyon.fr
Contact: Tiphanie Ginhoux 0427 857 723 ext +33 tiphanie.ginhoux01@chu-lyon.fr

Locations
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France
Groupement Hospitalier Nord-Daupine Not yet recruiting
Bourgoin-Jallieu, France, 38300
Contact: Marie BAILS-DE-GEORGES, MD,PhD       mdegeorges@ghnd.fr   
Principal Investigator: Marie BAILS-DE-GEORGES, MD,PhD         
Hôpital femme-mère-enfant Recruiting
Bron, France, 69677
Contact: Etienne JAVOUHEY, PU,PH    04.72.12.97.35 ext +33    etienne.javouhey@chu-lyon.fr   
Principal Investigator: Etienne JAVOUHEY, PU,PH         
Hôpital Louis Pradel Recruiting
Bron, France, 69677
Contact: Aurélie PORTEFAIX, MD,PhD       aurelie.portefaix@chu-lyon.fr   
Contact: Vincent COTTIN, PU,PH       vincent.cottin@chu-lyon.fr   
Principal Investigator: Aurélie PORTEFAIX, MD,PhD         
Principal Investigator: Vincent COTTIN, PU,PH         
Hôpital Louis Mourier Not yet recruiting
Colombes, France, 92700
Contact: Romain BASMACI, PU,PH       romain.basmaci@aphp.fr   
Principal Investigator: Romain BASMACI, PU,PH         
Centre Hospitalo-Universitaire de Grenoble Not yet recruiting
La Tronche, France, 38700
Contact: Guillaume MORTAMET, MD,PhD       gmortamet@chu-grenoble.fr   
Principal Investigator: Guillaume MORTAMET, MD,PhD         
Hopital de la Croix-Rousse Recruiting
Lyon, France, 69317
Contact: Florent VALOUR, PhD    04.72.07.11.07 ext +33    florent.valour@chu-lyon.fr   
Principal Investigator: Florent VALOUR, PhD         
Principal Investigator: Yvan JAMILLOUX, PhD         
Principal Investigator: Thomas JULLIEN, PhD         
Hôpital Edouard Herriot Not yet recruiting
Lyon, France, 69437
Contact: Thomas BARBA, MD,PhD       thomas.barba@chu-lyon.fr   
Principal Investigator: Thomas BARBA, MD,PhD         
Hôpital mère - enfant Nantes Not yet recruiting
Nantes, France, 44093
Contact: Nicolas JORAM, MD,PhD       nicolas.joram@chu-nantes.fr   
Contact: Christèle GRAS-LE-GUEN, PU,PH       christele.grasleguen@chu-nantes.fr   
Principal Investigator: Nicolas JORAM, MD,PhD         
Principal Investigator: Christèle GRAS-LE-GUEN, PU,PH         
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre-Bénite, France, 69495
Contact: Hervé LOBBES, MD,PhD       herve.lobbes@chu-lyon.fr   
Contact: Sébastien COURAUD, PU,PH       sebastien.couraud@chu-lyon.fr   
Principal Investigator: Hervé LOBBES, MD,PhD         
Principal Investigator: Sébastien COURAUD, PU,PH         
Principal Investigator: Cyrille CONFAVREUX, PU,PH         
Hôpital Nord de Saint Etienne Not yet recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Hugues PATURAL, PU,PH       hugues.patural@chu-st-etienne.fr   
Principal Investigator: Hugues PATURAL, PU,PH         
Hôpital Nord-Ouest Not yet recruiting
Villefranche-sur-Saône, France, 69655
Contact: Philippe REBAUD, MD,PhD       prebaud@lhopitalnordouest.fr   
Principal Investigator: Philippe REBAUD, MD,PhD         
Centre Hospitalier D'Annecy-Genevois Not yet recruiting
Épagny, France, 74370
Contact: Clémence JARRASSE, MD,PhD       cjarrasse@ch-annecygenevois.fr   
Principal Investigator: Clémence JARRASSE, MD,PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04376476    
Other Study ID Numbers: 69HCL20_0342
2020-A01102-37 ( Other Identifier: ID-RCB )
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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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 Hospices Civils de Lyon:
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
immunology
interferon
coronavirus
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases