Contact Case, Covid19
Conditions
Keywords
SARS-CoV-2, COVID19, Confirmed case, Biological collection, contact case, cluster
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.
Interventions
BIOLOGICALBiological collection with nasopharyngeal samples, saliva, blood, stool and urine
Subjects with a COVID-19 infection and their 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 Day0 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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virological profile | Day 0 | Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT) |
| Virological profile (serology) | Day 0 | 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 (cytokine) | Day 0 | cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL |
| Immunological profile with blood level for markers of inflammation | Day 0 | markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or % |
| Biochemical profile by blood dosage of CRP | Day 0 | CRP in mg/l |
| Biochemical profile by blood dosage of ASAT/ALAT | Day 0 | ASAT/ALAT in U/L |
| Biochemical profile by blood dosage of LDH | Day 0 | LDH in U/L |
| Biochemical profile by blood dosage of Lactate | Day 0 | Lactate in mg/l |
| Biochemical profile by blood dosage of D-Dimer | Day 0 | D-Dimer in µg/L |
| Biochemical profile by blood dosage of Troponin | Day 0 | Troponin in µg/L |
| Biochemical profile by blood dosage of Ferritin | Day 0 | Ferritin in µg/L |
| Biochemical profile by blood dosage of RAGE | 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 SUPAR | Day 0 | SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein |
| Haematological profile by blood dosage of leukocytes | Day 0 | leukocytes in Giga/L |
| Haematological profile by blood dosage of Red blood cells | Day 0 | Red blood cells in Tera/L |
| Haematological profile by blood dosage of Hemoglobin | Day 0 | Hemoglobin in g/dL |
| Haematological profile by blood dosage of Hematocrit | Day 0 | Hematocrit in % |
| Haematological profile by blood dosage of Mean corpuscular volume | Day 0 | Mean corpuscular volume in fL |
| Haematological profile by blood dosage of Mean corpuscular hemoglobin | Day 0 | Mean corpuscular hemoglobin in pg |
| Haematological profile by blood dosage of average corpuscular concentration of haemoglobin | Day 0 | Average corpuscular concentration of haemoglobin in g/dL |
| Haematological profile by blood dosage of polynuclear neutrophil | Day 0 | polynuclear neutrophil in Giga/L |
| Haematological profile by blood dosage of polynuclear eosinophils | Day 0 | polynuclear eosinophils in Giga/L |
| Haematological profile by blood dosage of polynuclear basophils | Day 0 | polynuclear basophils in Giga/L |
| Haematological profile by blood dosage of lymphocytes | Day 0 | lymphocytes in Giga/L |
| Haematological profile by blood dosage of monocytes | Day 90 | monocytes in Giga/L |
| Haematological profile by blood dosage of platelets | Day 0 | platelets in Giga/L |
| Haematological profile by blood dosage of activated partial thromboplastin time | Day 0 | activated partial thromboplastin time in second/witness |
| Haematological profile by blood dosage of fibrinogen | Day 0 | fibrinogen in g/L |
| Haematological profile by blood dosage of factor V | Day 0 | factor V in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia | Day 0 | Insomnia in terms of presence/absence |
| Angina | Day 0 | Angina in terms of presence/absence |
| Ageusia | Day 0 | Ageusia in terms of presence/absence |
| Comparison of viral sequences | Day 0 | bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values) |
| transmission rate | Day 0 | Rate of viral transmission determine by bioinformatic and statistical analyzes in % |
| prolonged viral shedding | between day 0 and day 21 | Prolonged viral shedding evaluate by RT-PCR (CT value or log10 copies per mL) |
| Respiratory complaints | Day 0 | Respiratory complaints in term of SRIpr score from 0 to 100 |
| microbiota analysis | Day 0 | bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values) |
| SARS-CoV-2 salivary viral load | Day 0 | RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL |
| environmental and societal factors (EPICE) | Day 0 | EPICE score (Assessment of precariousness and health inequalities in examination centers Health) at day 0 from 0 to 100 |
| environmental and societal factors | Day 0 | eating habits |
| environmental and societal factors (SF-36) | Day 0 | SF-36 score (quality of life by Gardenal O) from 0 to 100 |
| environmental and societal factors (Physical activity) | Day 0 | Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100 |
| body weight | Day 0 | body weight in kg |
| oxygen saturation | Day 0 | oxygen saturation in % |
| Respiratory rate | Day 0 | Respiratory rate per minute |
| cardiac frequency | Day 0 | cardiac frequency per minute |
| lung damage | Day 0 | Lung damage on auscultation in terms of presence/absence |
| lung evolution | day 90 | CT san in terms of normal/abnormal (children and pregnant women not concerned) |
| blood pressure | Day 0 | Dysatolic/systolic blood pressure in mmHg |
| body temperature | Day 0 | Body temperature in °C |
| clinical exam (skin) | Day 0 | Skin mottling in terms of presence/absence |
| clinical exam (polypnea) | Day 0 | polypnea in terms of presence/absence |
| denutrition | Day 0 | denutrition in terms of presence/absence |
| Antibiotic treatment | Day 0 | Antibiotic treatment in terms of presence/absence with precision if necessary |
| Steroidal anti-inflammatory treatment | Day 0 | Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary |
| Anti-diabetic treatment | Day 0 | Anti-diabetic treatment in terms of presence/absence with precision if necessary |
| Gastric protector treatment | Day 0 | Gastric protector treatment in terms of presence/absence with precision if necessary |
| chills | Day 0 | chills in terms of presence/absence |
| Myalgia | Day 0 | Myalgia in terms of presence/absence |
| Anorexia | Day 0 | Anorexia in terms of presence/absence |
| Rhinitis | Day 0 | Rhinitis in terms of presence/absence |
| Confusion | Day 0 | Confusion in terms of presence/absence |
| Asthenia | Day 0 | Asthenia in terms of presence/absence |
| Falls at home | Day 0 | Falls at home in terms of presence/absence |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed