Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2020-05-05
2022-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Blood sample
blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Low or upper respiratory tract sample
Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14
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).
Blood sample
blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Low or upper respiratory tract sample
Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Stool collection or fecal swab
The stool collection or fecal swab will be collected in order to take virology measurements:
Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0
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.
Blood sample
blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Low or upper respiratory tract sample
Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Stool collection or fecal swab
The stool collection or fecal swab will be collected in order to take virology measurements:
Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0
phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14
Interventions
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Blood sample
blood samples will be taken as below: Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Low or upper respiratory tract sample
Low or upper respiratory tract sample will be collected in order to take virology measurements:
Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
Stool collection or fecal swab
The stool collection or fecal swab will be collected in order to take virology measurements:
Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0
phone call
phone calls will be performed to collect data regarding patients' symptoms at: Group E1: Day 14 Group E3: Day 14
Eligibility Criteria
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Inclusion Criteria
* 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 (or hospitalization not related to a SARS-CoV-2 infection);
* 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
* Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
* Other Suspected or proved infection
* 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.
1 Day
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Groupement Hospitalier Nord-Daupine
Bourgoin, , France
Hôpital femme-mère-enfant
Bron, , France
Hôpital Louis Pradel
Bron, , France
Hôpital Louis Mourier
Colombes, , France
Centre Hospitalier D'Annecy-Genevois
Épagny, , France
Centre Hospitalo-Universitaire de Grenoble
La Tronche, , France
Hopital de la Croix-Rousse
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital mère - enfant Nantes
Nantes, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hôpital Nord de Saint Etienne
Saint-Priest-en-Jarez, , France
Hôpital Nord-Ouest
Villefranche-sur-Saône, , France
Countries
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Other Identifiers
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2020-A01102-37
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL20_0342
Identifier Type: -
Identifier Source: org_study_id
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