Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
2020年10月21日 更新者：University Hospital, Clermont-Ferrand
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
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).
研究概览
地位
未知
条件
详细说明
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.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Clermont-Ferrand、法国、63000
- CHU de Clermont-Ferrand
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：cohort
Biological 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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Virological profile
大体时间：Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
大体时间：Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
大体时间：Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
大体时间：Day 0
|
SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)
|
Day 0
|
|
Virological profile (serology)
大体时间：Day 10
|
SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)
|
Day 10
|
|
Virological profile (serology)
大体时间：Day 21
|
SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)
|
Day 21
|
|
Immunological profile with blood level for markers of inflammation (cytokine)
大体时间：Day 0
|
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
|
Day 0
|
|
Immunological profile with blood level for markers of inflammation (cytokine)
大体时间：Day 10
|
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
|
Day 10
|
|
Immunological profile with blood level for markers of inflammation (cytokine)
大体时间：Day 21
|
cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL
|
Day 21
|
|
Immunological profile with blood level for markers of inflammation
大体时间：Day 0
|
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
|
Day 0
|
|
Immunological profile with blood level for markers of inflammation
大体时间：Day 10
|
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
|
Day 10
|
|
Immunological profile with blood level for markers of inflammation
大体时间：Day 21
|
markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
大体时间：Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
大体时间：Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
大体时间：Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
大体时间：Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
大体时间：Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
大体时间：Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
大体时间：Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
大体时间：Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
大体时间：Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
大体时间：Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
大体时间：Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
大体时间：Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
大体时间：Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
大体时间：Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
大体时间：Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
大体时间：Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
大体时间：Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
大体时间：Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
大体时间：Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
大体时间：Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
大体时间：Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
大体时间：Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
大体时间：Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
大体时间：Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
大体时间：Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
大体时间：Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
大体时间：Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
大体时间：Day 0
|
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
|
Day 0
|
|
Biochemical profile by blood dosage of RAGE
大体时间：Day 10
|
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
|
Day 10
|
|
Biochemical profile by blood dosage of RAGE
大体时间：Day 21
|
RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein
|
Day 21
|
|
Biochemical profile by blood dosage of SUPAR
大体时间：Day 0
|
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
|
Day 0
|
|
Biochemical profile by blood dosage of SUPAR
大体时间：Day 10
|
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
|
Day 10
|
|
Biochemical profile by blood dosage of SUPAR
大体时间：Day 21
|
SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
大体时间：Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
大体时间：Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
大体时间：Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
大体时间：Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
大体时间：Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
大体时间：Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
大体时间：Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
大体时间：Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
大体时间：Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
大体时间：Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
大体时间：Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
大体时间：Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
大体时间：Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
大体时间：Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
大体时间：Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
大体时间：Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
大体时间：Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
大体时间：Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
大体时间：Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
大体时间：Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
大体时间：Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
大体时间：Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
大体时间：Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
大体时间：Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
大体时间：Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
大体时间：Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
大体时间：Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
大体时间：Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
大体时间：Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
大体时间：Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
大体时间：Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
大体时间：Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
大体时间：Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
大体时间：Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
大体时间：Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
大体时间：Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
大体时间：Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
大体时间：Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
大体时间：Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
大体时间：Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
大体时间：Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
大体时间：Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
大体时间：Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
大体时间：Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
大体时间：Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
大体时间：Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
大体时间：Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
大体时间：Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
大体时间：Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
大体时间：Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
大体时间：Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
大体时间：Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
大体时间：Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
大体时间：Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
大体时间：Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
大体时间：Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
大体时间：Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
大体时间：Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
大体时间：Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
大体时间：Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
大体时间：Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
大体时间：Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
大体时间：Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
大体时间：Day 90
|
factor V in %
|
Day 90
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SARS-CoV-2 salivary viral load
大体时间：Day 0
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 0
|
|
SARS-CoV-2 salivary viral load
大体时间：Day 10
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 10
|
|
SARS-CoV-2 salivary viral load
大体时间：Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
大体时间：Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
大体时间：Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
大体时间：Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
大体时间：Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
大体时间：Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
大体时间：Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
大体时间：Day 0
|
EPICE score (Assessment of precariousness and health inequalities in examination centers Health) at day 0 from 0 to 100
|
Day 0
|
|
environmental and societal factors
大体时间：Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
大体时间：day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
大体时间：day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
大体时间：day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
大体时间：Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
大体时间：day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
大体时间：day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
大体时间：day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
大体时间：Day 0
|
Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100
|
Day 0
|
|
environmental and societal factors (Physical activity)
大体时间：day 10
|
Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100
|
day 10
|
|
environmental and societal factors (Physical activity)
大体时间：day 21
|
Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100
|
day 21
|
|
environmental and societal factors (Physical activity)
大体时间：day 90
|
Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100
|
day 90
|
|
body weight
大体时间：Day 0
|
body weight in kg
|
Day 0
|
|
body weight
大体时间：day 10
|
body weight in kg
|
day 10
|
|
body weight
大体时间：day 21
|
body weight in kg
|
day 21
|
|
body weight
大体时间：day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
大体时间：Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
大体时间：day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
大体时间：day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
大体时间：day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
大体时间：Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
大体时间：day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
大体时间：day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
大体时间：day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
大体时间：Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
大体时间：day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
大体时间：day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
大体时间：day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
大体时间：Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
大体时间：day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
大体时间：day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
大体时间：day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
大体时间：day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
大体时间：Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
大体时间：day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
大体时间：day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
大体时间：day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
大体时间：Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
大体时间：day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
大体时间：day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
大体时间：day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
大体时间：Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
大体时间：day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
大体时间：day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
大体时间：day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
大体时间：Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
大体时间：day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
大体时间：day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
大体时间：day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
大体时间：Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
大体时间：day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
大体时间：day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
大体时间：day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
大体时间：Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
大体时间：day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
大体时间：day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
大体时间：day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
大体时间：Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
大体时间：day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
大体时间：day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
大体时间：day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
大体时间：Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
大体时间：day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
大体时间：day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
大体时间：day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
大体时间：Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
大体时间：day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
大体时间：day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
大体时间：day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
大体时间：Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
大体时间：day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
大体时间：day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
大体时间：day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
大体时间：Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
大体时间：day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
大体时间：day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
大体时间：day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
大体时间：Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
大体时间：day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
大体时间：day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
大体时间：day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
大体时间：Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
大体时间：day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
大体时间：day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
大体时间：day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
大体时间：Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
大体时间：day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
大体时间：day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
大体时间：day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
大体时间：Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
大体时间：day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
大体时间：day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
大体时间：day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
大体时间：Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
大体时间：day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
大体时间：day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
大体时间：day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
大体时间：Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
大体时间：day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
大体时间：day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
大体时间：day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
大体时间：Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
大体时间：day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
大体时间：day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
大体时间：day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
大体时间：Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
大体时间：day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
大体时间：day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
大体时间：day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
大体时间：Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
大体时间：day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
大体时间：day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
大体时间：day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
大体时间：day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
大体时间：day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
大体时间：day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
大体时间：day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
大体时间：Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
大体时间：day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
大体时间：day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
大体时间：between day 0 and day 21
|
Prolonged viral shedding evaluate by RT-PCR (CT value or log10 copies per mL)
|
between day 0 and day 21
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Céclie Henquell、University Hospital, Clermont-Ferrand
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年11月1日
初级完成 (预期的)
2021年11月1日
研究完成 (预期的)
2022年2月1日
研究注册日期
首次提交
2020年10月2日
首先提交符合 QC 标准的
2020年10月21日
首次发布 (实际的)
2020年10月22日
研究记录更新
最后更新发布 (实际的)
2020年10月22日
上次提交的符合 QC 标准的更新
2020年10月21日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.