Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT)
- Conditions
- Covid19Contact Case
- Interventions
- Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine
- Registration Number
- NCT04597736
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
- Refusal of the child
- Refusal of participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cohort Biological collection with nasopharyngeal samples, saliva, blood, stool and urine Biological collection with nasopharyngeal samples, saliva, blood, stool and urine
- Primary Outcome Measures
Name Time Method Haematological profile by blood dosage of monocytes Day 21 monocytes in Giga/L
Virological profile 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 Day 90 CRP in mg/l
Biochemical profile by blood dosage of Troponin Day 90 Troponin in µg/L
Biochemical profile by blood dosage of RAGE Day 21 RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
Virological profile (serology) 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 Day 21 markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
Biochemical profile by blood dosage of LDH Day 90 LDH in U/L
Biochemical profile by blood dosage of D-Dimer Day 90 D-Dimer in µg/L
Haematological profile by blood dosage of leukocytes Day 90 leukocytes in Giga/L
Biochemical profile by blood dosage of ASAT/ALAT Day 90 ASAT/ALAT in U/L
Biochemical profile by blood dosage of SUPAR 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 Day 90 Mean corpuscular volume in fL
Haematological profile by blood dosage of activated partial thromboplastin time Day 90 activated partial thromboplastin time in second/witness
Haematological profile by blood dosage of fibrinogen Day 90 fibrinogen in g/L
Immunological profile with blood level for markers of inflammation (cytokine) Day 21 cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
Biochemical profile by blood dosage of Lactate Day 90 Lactate in mg/l
Haematological profile by blood dosage of Red blood cells Day 90 Red blood cells in Tera/L
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin Day 90 Average corpuscular concentration of haemoglobin in g/dL
Biochemical profile by blood dosage of Ferritin Day 21 Ferritin in µg/L
Haematological profile by blood dosage of Mean corpuscular hemoglobin Day 90 Mean corpuscular hemoglobin in pg
Haematological profile by blood dosage of polynuclear basophils Day 90 polynuclear basophils in Giga/L
Haematological profile by blood dosage of lymphocytes Day 90 lymphocytes in Giga/L
Haematological profile by blood dosage of Hemoglobin Day 90 Hemoglobin in g/dL
Haematological profile by blood dosage of Hematocrit Day 90 Hematocrit in %
Haematological profile by blood dosage of polynuclear neutrophil Day 90 polynuclear neutrophil in Giga/L
Haematological profile by blood dosage of factor V Day 90 factor V in %
Haematological profile by blood dosage of polynuclear eosinophils Day 90 polynuclear eosinophils in Giga/L
Haematological profile by blood dosage of platelets Day 90 platelets in Giga/L
- Secondary Outcome Measures
Name Time Method Insomnia day 90 Insomnia in terms of presence/absence
Comparison of viral sequences Day 21 bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
clinical exam (polypnea) day 90 polypnea in terms of presence/absence
Antibiotic treatment day 90 Antibiotic treatment in terms of presence/absence with precision if necessary
SARS-CoV-2 salivary viral load Day 21 RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
microbiota analysis Day 21 bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
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
blood pressure day 90 Dysatolic/systolic blood pressure in mmHg
clinical exam (skin) day 90 Skin mottling in terms of presence/absence
Gastric protector treatment day 90 Gastric protector treatment in terms of presence/absence with precision if necessary
Ageusia day 90 Ageusia in terms of presence/absence
Respiratory complaints day 90 Respiratory complaints in term of SRIpr score from 0 to 100
environmental and societal factors (SF-36) day 90 SF-36 score (quality of life by Gardenal O) from 0 to 100
oxygen saturation day 90 oxygen saturation in %
transmission rate day 21 Rate of viral transmission determine by bioinformatic and statistical analyzes in %
chills day 90 chills in terms of presence/absence
environmental and societal factors (Physical activity) day 90 Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100
denutrition day 90 denutrition in terms of presence/absence
Confusion day 90 Confusion in terms of presence/absence
Asthenia day 90 Asthenia in terms of presence/absence
body weight day 90 body weight in kg
Respiratory rate day 90 Respiratory rate per minute
cardiac frequency day 90 cardiac frequency per minute
Steroidal anti-inflammatory treatment day 90 Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
Anti-diabetic treatment day 90 Anti-diabetic treatment in terms of presence/absence with precision if necessary
Myalgia day 90 Myalgia in terms of presence/absence
Rhinitis day 90 Rhinitis in terms of presence/absence
environmental and societal factors day 90 eating habits
lung damage day 90 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)
body temperature day 90 Body temperature in °C
Anorexia day 90 Anorexia in terms of presence/absence
Angina day 90 Angina in terms of presence/absence
prolonged viral shedding between day 0 and day 21 Prolonged viral shedding evaluate by RT-PCR (CT value or log10 copies per mL)
Falls at home day 90 Falls at home in terms of presence/absence
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France