Biological Collection for the Study of the Relationship Between the Biological Profiles Observed and the Clinical Evolutions Within the Same Cluster of Transmission of the Coronavirus SARS-CoV-2
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Study Overview
Brief Summary
The hypothesis is that from a cluster defined by a confirmed positive case of COVID-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of COVID-19 infection and to explore the biological profiles related to the observed clinical history. Certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care.
The main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus SARS-CoV-2 (positive COVID-19 cases and contact subjects).
Detailed Description
Subjects with a COVID-19 infection and thei contact cases (identification according to health insurance criteria, see "Améli.fr") will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel.
For the main objective: during the D0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine.
For secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative RT-PCR test on D0. A final consultation will be carried out at M3. Nasopharyngeal samples, saliva, blood, stool and urine will be taken on D10 and D21. A blood test will be taken at M3 to carry out a COVID-19 serology.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Child or adult, no age limit
- •Able to give informed consent to participate in research
- •If a minor participant: consent of the legal representatives
- •If confirmed case COVID-19 (symptomatic or asymptomatic): laboratory result confirming infection with SARS-CoV-2 by RT-PCR or by serology
- •If contact case: people identified as a risk contact according to the criteria of the "Amélie.fr" health insurance
Exclusion Criteria
- •Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
- •Refusal of the child
- •Refusal of participation
Arms & Interventions
cohort
Biological collection with nasopharyngeal samples, saliva, blood, stool and urine
Intervention: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine (Biological)
Outcomes
Primary Outcomes
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Time Frame: Day 90
Average corpuscular concentration of haemoglobin in g/dL
Haematological profile by blood dosage of Hematocrit
Time Frame: Day 90
Hematocrit in %
Virological profile
Time Frame: Day 21
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
Biochemical profile by blood dosage of CRP
Time Frame: Day 90
CRP in mg/l
Biochemical profile by blood dosage of Troponin
Time Frame: Day 90
Troponin in µg/L
Biochemical profile by blood dosage of RAGE
Time Frame: Day 21
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
Virological profile (serology)
Time Frame: Day 21
SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)
Immunological profile with blood level for markers of inflammation
Time Frame: Day 21
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
Biochemical profile by blood dosage of LDH
Time Frame: Day 90
LDH in U/L
Biochemical profile by blood dosage of D-Dimer
Time Frame: Day 90
D-Dimer in µg/L
Haematological profile by blood dosage of monocytes
Time Frame: Day 21
monocytes in Giga/L
Haematological profile by blood dosage of leukocytes
Time Frame: Day 90
leukocytes in Giga/L
Biochemical profile by blood dosage of ASAT/ALAT
Time Frame: Day 90
ASAT/ALAT in U/L
Biochemical profile by blood dosage of SUPAR
Time Frame: Day 21
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
Haematological profile by blood dosage of Mean corpuscular volume
Time Frame: Day 90
Mean corpuscular volume in fL
Haematological profile by blood dosage of activated partial thromboplastin time
Time Frame: Day 90
activated partial thromboplastin time in second/witness
Haematological profile by blood dosage of fibrinogen
Time Frame: Day 90
fibrinogen in g/L
Immunological profile with blood level for markers of inflammation (cytokine)
Time Frame: Day 21
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
Biochemical profile by blood dosage of Lactate
Time Frame: Day 90
Lactate in mg/l
Haematological profile by blood dosage of Red blood cells
Time Frame: Day 90
Red blood cells in Tera/L
Biochemical profile by blood dosage of Ferritin
Time Frame: Day 21
Ferritin in µg/L
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Time Frame: Day 90
Mean corpuscular hemoglobin in pg
Haematological profile by blood dosage of polynuclear basophils
Time Frame: Day 90
polynuclear basophils in Giga/L
Haematological profile by blood dosage of lymphocytes
Time Frame: Day 90
lymphocytes in Giga/L
Haematological profile by blood dosage of Hemoglobin
Time Frame: Day 90
Hemoglobin in g/dL
Haematological profile by blood dosage of polynuclear neutrophil
Time Frame: Day 90
polynuclear neutrophil in Giga/L
Haematological profile by blood dosage of factor V
Time Frame: Day 90
factor V in %
Haematological profile by blood dosage of polynuclear eosinophils
Time Frame: Day 90
polynuclear eosinophils in Giga/L
Haematological profile by blood dosage of platelets
Time Frame: Day 90
platelets in Giga/L
Virological profile
Time Frame: Day 0
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
Virological profile
Time Frame: Day 10
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
Virological profile (serology)
Time Frame: Day 0
SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)
Virological profile (serology)
Time Frame: Day 10
SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)
Biochemical profile by blood dosage of CRP
Time Frame: Day 21
CRP in mg/l
Immunological profile with blood level for markers of inflammation (cytokine)
Time Frame: Day 0
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
Immunological profile with blood level for markers of inflammation (cytokine)
Time Frame: Day 10
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
Immunological profile with blood level for markers of inflammation
Time Frame: Day 0
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
Immunological profile with blood level for markers of inflammation
Time Frame: Day 10
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
Biochemical profile by blood dosage of CRP
Time Frame: Day 0
CRP in mg/l
Biochemical profile by blood dosage of CRP
Time Frame: Day 10
CRP in mg/l
Biochemical profile by blood dosage of ASAT/ALAT
Time Frame: Day 0
ASAT/ALAT in U/L
Biochemical profile by blood dosage of ASAT/ALAT
Time Frame: Day 10
ASAT/ALAT in U/L
Biochemical profile by blood dosage of ASAT/ALAT
Time Frame: Day 21
ASAT/ALAT in U/L
Biochemical profile by blood dosage of LDH
Time Frame: Day 0
LDH in U/L
Biochemical profile by blood dosage of LDH
Time Frame: Day 10
LDH in U/L
Biochemical profile by blood dosage of LDH
Time Frame: Day 21
LDH in U/L
Biochemical profile by blood dosage of Lactate
Time Frame: Day 0
Lactate in mg/l
Biochemical profile by blood dosage of Lactate
Time Frame: Day 10
Lactate in mg/l
Biochemical profile by blood dosage of Lactate
Time Frame: Day 21
Lactate in mg/l
Biochemical profile by blood dosage of D-Dimer
Time Frame: Day 0
D-Dimer in µg/L
Biochemical profile by blood dosage of D-Dimer
Time Frame: Day 10
D-Dimer in µg/L
Biochemical profile by blood dosage of D-Dimer
Time Frame: Day 21
D-Dimer in µg/L
Biochemical profile by blood dosage of Troponin
Time Frame: Day 0
Troponin in µg/L
Biochemical profile by blood dosage of Troponin
Time Frame: Day 10
Troponin in µg/L
Biochemical profile by blood dosage of Troponin
Time Frame: Day 21
Troponin in µg/L
Biochemical profile by blood dosage of Ferritin
Time Frame: Day 0
Ferritin in µg/L
Biochemical profile by blood dosage of Ferritin
Time Frame: Day 10
Ferritin in µg/L
Biochemical profile by blood dosage of RAGE
Time Frame: Day 0
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
Biochemical profile by blood dosage of RAGE
Time Frame: Day 10
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
Biochemical profile by blood dosage of SUPAR
Time Frame: Day 0
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
Biochemical profile by blood dosage of SUPAR
Time Frame: Day 10
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
Haematological profile by blood dosage of leukocytes
Time Frame: Day 0
leukocytes in Giga/L
Haematological profile by blood dosage of leukocytes
Time Frame: Day 10
leukocytes in Giga/L
Haematological profile by blood dosage of leukocytes
Time Frame: Day 21
leukocytes in Giga/L
Haematological profile by blood dosage of Red blood cells
Time Frame: Day 0
Red blood cells in Tera/L
Haematological profile by blood dosage of Red blood cells
Time Frame: Day 10
Red blood cells in Tera/L
Haematological profile by blood dosage of Red blood cells
Time Frame: Day 21
Red blood cells in Tera/L
Haematological profile by blood dosage of Hemoglobin
Time Frame: Day 0
Hemoglobin in g/dL
Haematological profile by blood dosage of Hemoglobin
Time Frame: Day 10
Hemoglobin in g/dL
Haematological profile by blood dosage of Hemoglobin
Time Frame: Day 21
Hemoglobin in g/dL
Haematological profile by blood dosage of Hematocrit
Time Frame: Day 0
Hematocrit in %
Haematological profile by blood dosage of Hematocrit
Time Frame: Day 10
Hematocrit in %
Haematological profile by blood dosage of Hematocrit
Time Frame: Day 21
Hematocrit in %
Haematological profile by blood dosage of Mean corpuscular volume
Time Frame: Day 0
Mean corpuscular volume in fL
Haematological profile by blood dosage of Mean corpuscular volume
Time Frame: Day 10
Mean corpuscular volume in fL
Haematological profile by blood dosage of Mean corpuscular volume
Time Frame: Day 21
Mean corpuscular volume in fL
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Time Frame: Day 0
Mean corpuscular hemoglobin in pg
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Time Frame: Day 10
Mean corpuscular hemoglobin in pg
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Time Frame: Day 21
Mean corpuscular hemoglobin in pg
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Time Frame: Day 0
Average corpuscular concentration of haemoglobin in g/dL
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Time Frame: Day 10
Average corpuscular concentration of haemoglobin in g/dL
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Time Frame: Day 21
Average corpuscular concentration of haemoglobin in g/dL
Haematological profile by blood dosage of polynuclear neutrophil
Time Frame: Day 0
polynuclear neutrophil in Giga/L
Haematological profile by blood dosage of polynuclear neutrophil
Time Frame: Day 10
polynuclear neutrophil in Giga/L
Haematological profile by blood dosage of polynuclear neutrophil
Time Frame: Day 21
polynuclear neutrophil in Giga/L
Haematological profile by blood dosage of polynuclear eosinophils
Time Frame: Day 0
polynuclear eosinophils in Giga/L
Haematological profile by blood dosage of polynuclear eosinophils
Time Frame: Day 10
polynuclear eosinophils in Giga/L
Haematological profile by blood dosage of polynuclear eosinophils
Time Frame: Day 21
polynuclear eosinophils in Giga/L
Haematological profile by blood dosage of polynuclear basophils
Time Frame: Day 0
polynuclear basophils in Giga/L
Haematological profile by blood dosage of polynuclear basophils
Time Frame: Day 10
polynuclear basophils in Giga/L
Haematological profile by blood dosage of polynuclear basophils
Time Frame: Day 21
polynuclear basophils in Giga/L
Haematological profile by blood dosage of lymphocytes
Time Frame: Day 0
lymphocytes in Giga/L
Haematological profile by blood dosage of lymphocytes
Time Frame: Day 10
lymphocytes in Giga/L
Haematological profile by blood dosage of lymphocytes
Time Frame: Day 21
lymphocytes in Giga/L
Haematological profile by blood dosage of monocytes
Time Frame: Day 90
monocytes in Giga/L
Haematological profile by blood dosage of monocytes
Time Frame: Day 0
monocytes in Giga/L
Haematological profile by blood dosage of monocytes
Time Frame: Day 10
monocytes in Giga/L
Haematological profile by blood dosage of platelets
Time Frame: Day 0
platelets in Giga/L
Haematological profile by blood dosage of platelets
Time Frame: Day 10
platelets in Giga/L
Haematological profile by blood dosage of platelets
Time Frame: Day 21
platelets in Giga/L
Haematological profile by blood dosage of activated partial thromboplastin time
Time Frame: Day 0
activated partial thromboplastin time in second/witness
Haematological profile by blood dosage of activated partial thromboplastin time
Time Frame: Day 10
activated partial thromboplastin time in second/witness
Haematological profile by blood dosage of activated partial thromboplastin time
Time Frame: Day 21
activated partial thromboplastin time in second/witness
Haematological profile by blood dosage of fibrinogen
Time Frame: Day 0
fibrinogen in g/L
Haematological profile by blood dosage of fibrinogen
Time Frame: Day 10
fibrinogen in g/L
Haematological profile by blood dosage of fibrinogen
Time Frame: Day 21
fibrinogen in g/L
Haematological profile by blood dosage of factor V
Time Frame: Day 0
factor V in %
Haematological profile by blood dosage of factor V
Time Frame: Day 10
factor V in %
Haematological profile by blood dosage of factor V
Time Frame: Day 21
factor V in %
Secondary Outcomes
- Comparison of viral sequences(Day 21)
- SARS-CoV-2 salivary viral load(Day 21)
- microbiota analysis(Day 21)
- environmental and societal factors (EPICE)(Day 0)
- blood pressure(day 90)
- clinical exam (skin)(day 90)
- Gastric protector treatment(day 90)
- Ageusia(day 90)
- environmental and societal factors (SF-36)(day 90)
- oxygen saturation(day 90)
- chills(day 90)
- environmental and societal factors (Physical activity)(day 90)
- denutrition(day 90)
- Confusion(day 90)
- Respiratory complaints(day 90)
- transmission rate(day 21)
- body weight(day 90)
- Respiratory rate(day 90)
- cardiac frequency(day 90)
- Steroidal anti-inflammatory treatment(day 90)
- Anti-diabetic treatment(day 90)
- Myalgia(day 90)
- Rhinitis(day 90)
- Asthenia(day 90)
- environmental and societal factors(day 90)
- lung damage(day 90)
- lung evolution(day 90)
- body temperature(day 90)
- clinical exam (polypnea)(day 90)
- Antibiotic treatment(day 90)
- Anorexia(day 90)
- Angina(day 90)
- Falls at home(day 90)
- Insomnia(day 90)
- prolonged viral shedding(between day 0 and day 21)
- cardiac frequency(Day 0)
- oxygen saturation(day 21)
- Respiratory rate(Day 0)
- Respiratory rate(day 10)
- cardiac frequency(day 10)
- SARS-CoV-2 salivary viral load(Day 0)
- SARS-CoV-2 salivary viral load(Day 10)
- Comparison of viral sequences(Day 0)
- Comparison of viral sequences(Day 10)
- microbiota analysis(Day 0)
- microbiota analysis(Day 10)
- environmental and societal factors(Day 0)
- environmental and societal factors(day 10)
- environmental and societal factors(day 21)
- environmental and societal factors (SF-36)(Day 0)
- environmental and societal factors (SF-36)(day 10)
- environmental and societal factors (SF-36)(day 21)
- environmental and societal factors (Physical activity)(Day 0)
- environmental and societal factors (Physical activity)(day 10)
- Respiratory rate(day 21)
- environmental and societal factors (Physical activity)(day 21)
- body weight(Day 0)
- body weight(day 10)
- body weight(day 21)
- oxygen saturation(Day 0)
- oxygen saturation(day 10)
- cardiac frequency(day 21)
- lung damage(Day 0)
- lung damage(day 10)
- lung damage(day 21)
- blood pressure(Day 0)
- blood pressure(day 10)
- blood pressure(day 21)
- body temperature(Day 0)
- body temperature(day 10)
- body temperature(day 21)
- clinical exam (skin)(Day 0)
- clinical exam (skin)(day 10)
- clinical exam (skin)(day 21)
- clinical exam (polypnea)(Day 0)
- clinical exam (polypnea)(day 10)
- clinical exam (polypnea)(day 21)
- denutrition(Day 0)
- denutrition(day 10)
- denutrition(day 21)
- Antibiotic treatment(Day 0)
- Antibiotic treatment(day 10)
- Antibiotic treatment(day 21)
- Steroidal anti-inflammatory treatment(Day 0)
- Steroidal anti-inflammatory treatment(day 10)
- Steroidal anti-inflammatory treatment(day 21)
- Anti-diabetic treatment(Day 0)
- Anti-diabetic treatment(day 10)
- Anti-diabetic treatment(day 21)
- Gastric protector treatment(Day 0)
- Gastric protector treatment(day 10)
- Gastric protector treatment(day 21)
- chills(Day 0)
- chills(day 10)
- chills(day 21)
- Myalgia(Day 0)
- Myalgia(day 10)
- Myalgia(day 21)
- Anorexia(Day 0)
- Anorexia(day 10)
- Anorexia(day 21)
- Rhinitis(Day 0)
- Rhinitis(day 10)
- Rhinitis(day 21)
- Confusion(Day 0)
- Confusion(day 10)
- Confusion(day 21)
- Asthenia(Day 0)
- Asthenia(day 10)
- Asthenia(day 21)
- Falls at home(Day 0)
- Falls at home(day 10)
- Falls at home(day 21)
- Insomnia(Day 0)
- Insomnia(day 10)
- Insomnia(day 21)
- Angina(Day 0)
- Angina(day 10)
- Angina(day 21)
- Ageusia(Day 0)
- Ageusia(day 10)
- Ageusia(day 21)
- Respiratory complaints(Day 0)
- Respiratory complaints(day 2)
- Respiratory complaints(day 4)
- Respiratory complaints(day 6)
- Respiratory complaints(day 8)
- Respiratory complaints(day 10)
- Respiratory complaints(day 21)
- transmission rate(Day 0)
- transmission rate(day 10)