Host-pathogen Interactions During SARS-CoV-2 Infection

  • STATUS
    Recruiting
  • participants needed
    450
  • sponsor
    Hospices Civils de Lyon
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Updated on 16 February 2024
See if I qualify
fever
pneumonia
PCR test
oxygen saturation
hypercytokinemia
oximetry
covid-19
SARS
interferon
respiratory symptom
respiratory tract infection
coronavirus infection
respiratory infection
middle east respiratory syndrome
cytokine storm
pediatric
acute respiratory syndrome (sars)

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.

Details
Condition Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2
Age 70years or below
Treatment Blood sample, Low or upper respiratory tract sample, Stool collection or fecal swab, Blood sample for whole genome sequencing, phone call
Clinical Study IdentifierNCT04376476
SponsorHospices Civils de Lyon
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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fever
pneumonia
PCR test
oxygen saturation
hypercytokinemia
oximetry
covid-19
SARS
interferon
respiratory symptom
respiratory tract infection
coronavirus infection
respiratory infection
middle east respiratory syndrome
cytokine storm
pediatric
acute respiratory syndrome (sars)

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