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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Haematological profile by blood dosage of fibrinogen
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
- •Refusal of the child
- •Refusal of participation
结局指标
主要结局
Haematological profile by blood dosage of fibrinogen
时间窗: Day 90
fibrinogen in g/L
Virological profile
时间窗: 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
时间窗: Day 90
CRP in mg/l
Biochemical profile by blood dosage of Troponin
时间窗: Day 90
Troponin in µg/L
Biochemical profile by blood dosage of RAGE
时间窗: Day 21
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
Virological profile (serology)
时间窗: 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
时间窗: Day 21
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
Biochemical profile by blood dosage of LDH
时间窗: Day 90
LDH in U/L
Biochemical profile by blood dosage of D-Dimer
时间窗: Day 90
D-Dimer in µg/L
Haematological profile by blood dosage of monocytes
时间窗: Day 21
monocytes in Giga/L
Haematological profile by blood dosage of Mean corpuscular volume
时间窗: Day 90
Mean corpuscular volume in fL
Haematological profile by blood dosage of activated partial thromboplastin time
时间窗: Day 90
activated partial thromboplastin time in second/witness
Haematological profile by blood dosage of leukocytes
时间窗: Day 90
leukocytes in Giga/L
Biochemical profile by blood dosage of ASAT/ALAT
时间窗: Day 90
ASAT/ALAT in U/L
Biochemical profile by blood dosage of SUPAR
时间窗: Day 21
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
Immunological profile with blood level for markers of inflammation (cytokine)
时间窗: Day 21
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
Biochemical profile by blood dosage of Lactate
时间窗: Day 90
Lactate in mg/l
Haematological profile by blood dosage of Red blood cells
时间窗: Day 90
Red blood cells in Tera/L
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
时间窗: Day 90
Average corpuscular concentration of haemoglobin in g/dL
Biochemical profile by blood dosage of Ferritin
时间窗: Day 21
Ferritin in µg/L
Haematological profile by blood dosage of Mean corpuscular hemoglobin
时间窗: Day 90
Mean corpuscular hemoglobin in pg
Haematological profile by blood dosage of polynuclear basophils
时间窗: Day 90
polynuclear basophils in Giga/L
Haematological profile by blood dosage of lymphocytes
时间窗: Day 90
lymphocytes in Giga/L
Haematological profile by blood dosage of Hemoglobin
时间窗: Day 90
Hemoglobin in g/dL
Haematological profile by blood dosage of Hematocrit
时间窗: Day 90
Hematocrit in %
Haematological profile by blood dosage of polynuclear neutrophil
时间窗: Day 90
polynuclear neutrophil in Giga/L
Haematological profile by blood dosage of factor V
时间窗: Day 90
factor V in %
Haematological profile by blood dosage of polynuclear eosinophils
时间窗: Day 90
polynuclear eosinophils in Giga/L
Haematological profile by blood dosage of platelets
时间窗: Day 90
platelets in Giga/L
次要结局
- 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)
- Anti-diabetic treatment(day 90)
- Myalgia(day 90)
- Rhinitis(day 90)
- body weight(day 90)
- Respiratory rate(day 90)
- cardiac frequency(day 90)
- Steroidal anti-inflammatory treatment(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)