Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21 de octubre de 2020 actualizado por: 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).
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Clermont-Ferrand, Francia, 63000
- CHU de Clermont-Ferrand
-
Sub-Investigador:
- Olivier Lesens
-
Investigador principal:
- Cécile Henquell
-
Sub-Investigador:
- Magali Vidal
-
Sub-Investigador:
- Marc Berger
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Virological profile
Periodo de tiempo: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Periodo de tiempo: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Periodo de tiempo: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Periodo de tiempo: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Periodo de tiempo: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Periodo de tiempo: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Periodo de tiempo: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Periodo de tiempo: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Periodo de tiempo: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Periodo de tiempo: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Periodo de tiempo: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Periodo de tiempo: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Periodo de tiempo: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Periodo de tiempo: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Periodo de tiempo: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Periodo de tiempo: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Periodo de tiempo: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Periodo de tiempo: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Periodo de tiempo: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Periodo de tiempo: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Periodo de tiempo: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Periodo de tiempo: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Periodo de tiempo: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Periodo de tiempo: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Periodo de tiempo: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Periodo de tiempo: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Periodo de tiempo: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Periodo de tiempo: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Periodo de tiempo: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Periodo de tiempo: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Periodo de tiempo: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Periodo de tiempo: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Periodo de tiempo: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Periodo de tiempo: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Periodo de tiempo: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Periodo de tiempo: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Periodo de tiempo: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Periodo de tiempo: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Periodo de tiempo: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Periodo de tiempo: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Periodo de tiempo: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Periodo de tiempo: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Periodo de tiempo: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Periodo de tiempo: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Periodo de tiempo: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Periodo de tiempo: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Periodo de tiempo: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Periodo de tiempo: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Periodo de tiempo: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Periodo de tiempo: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Periodo de tiempo: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Periodo de tiempo: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Periodo de tiempo: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Periodo de tiempo: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Periodo de tiempo: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Periodo de tiempo: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Periodo de tiempo: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Periodo de tiempo: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Periodo de tiempo: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Periodo de tiempo: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Periodo de tiempo: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Periodo de tiempo: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Periodo de tiempo: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Periodo de tiempo: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Periodo de tiempo: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Periodo de tiempo: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Periodo de tiempo: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Periodo de tiempo: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Periodo de tiempo: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Periodo de tiempo: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Periodo de tiempo: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Periodo de tiempo: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Periodo de tiempo: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Periodo de tiempo: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Periodo de tiempo: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Periodo de tiempo: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Periodo de tiempo: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Periodo de tiempo: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Periodo de tiempo: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Periodo de tiempo: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Periodo de tiempo: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Periodo de tiempo: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Periodo de tiempo: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Periodo de tiempo: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Periodo de tiempo: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Periodo de tiempo: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Periodo de tiempo: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Periodo de tiempo: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Periodo de tiempo: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Periodo de tiempo: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Periodo de tiempo: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Periodo de tiempo: Day 90
|
factor V in %
|
Day 90
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Periodo de tiempo: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Periodo de tiempo: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Periodo de tiempo: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Periodo de tiempo: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Periodo de tiempo: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Periodo de tiempo: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Periodo de tiempo: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Periodo de tiempo: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Periodo de tiempo: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Periodo de tiempo: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Periodo de tiempo: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Periodo de tiempo: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Periodo de tiempo: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Periodo de tiempo: day 10
|
body weight in kg
|
day 10
|
|
body weight
Periodo de tiempo: day 21
|
body weight in kg
|
day 21
|
|
body weight
Periodo de tiempo: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Periodo de tiempo: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Periodo de tiempo: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Periodo de tiempo: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Periodo de tiempo: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Periodo de tiempo: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Periodo de tiempo: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Periodo de tiempo: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Periodo de tiempo: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Periodo de tiempo: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Periodo de tiempo: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Periodo de tiempo: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Periodo de tiempo: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Periodo de tiempo: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Periodo de tiempo: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Periodo de tiempo: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Periodo de tiempo: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Periodo de tiempo: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Periodo de tiempo: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Periodo de tiempo: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Periodo de tiempo: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Periodo de tiempo: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Periodo de tiempo: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Periodo de tiempo: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Periodo de tiempo: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Periodo de tiempo: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Periodo de tiempo: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Periodo de tiempo: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Periodo de tiempo: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Periodo de tiempo: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Periodo de tiempo: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Periodo de tiempo: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Periodo de tiempo: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Periodo de tiempo: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Periodo de tiempo: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Periodo de tiempo: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Periodo de tiempo: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Periodo de tiempo: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Periodo de tiempo: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Periodo de tiempo: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Periodo de tiempo: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Periodo de tiempo: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Periodo de tiempo: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Periodo de tiempo: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Periodo de tiempo: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Periodo de tiempo: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Periodo de tiempo: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Periodo de tiempo: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Periodo de tiempo: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Periodo de tiempo: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Periodo de tiempo: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Periodo de tiempo: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Periodo de tiempo: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Periodo de tiempo: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Periodo de tiempo: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Periodo de tiempo: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Periodo de tiempo: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Periodo de tiempo: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Periodo de tiempo: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Periodo de tiempo: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Periodo de tiempo: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Periodo de tiempo: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Periodo de tiempo: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Periodo de tiempo: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Periodo de tiempo: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Periodo de tiempo: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Periodo de tiempo: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Periodo de tiempo: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Periodo de tiempo: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Periodo de tiempo: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Periodo de tiempo: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Periodo de tiempo: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Periodo de tiempo: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Periodo de tiempo: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Periodo de tiempo: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Periodo de tiempo: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Periodo de tiempo: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Periodo de tiempo: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Periodo de tiempo: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Periodo de tiempo: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Periodo de tiempo: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Periodo de tiempo: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Periodo de tiempo: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Periodo de tiempo: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Periodo de tiempo: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Periodo de tiempo: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Periodo de tiempo: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Periodo de tiempo: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Periodo de tiempo: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Periodo de tiempo: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Periodo de tiempo: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Periodo de tiempo: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Periodo de tiempo: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Periodo de tiempo: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Periodo de tiempo: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Periodo de tiempo: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Periodo de tiempo: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Periodo de tiempo: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Periodo de tiempo: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Periodo de tiempo: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Periodo de tiempo: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Periodo de tiempo: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Periodo de tiempo: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Periodo de tiempo: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Periodo de tiempo: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Céclie Henquell, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de noviembre de 2020
Finalización primaria (Anticipado)
1 de noviembre de 2021
Finalización del estudio (Anticipado)
1 de febrero de 2022
Fechas de registro del estudio
Enviado por primera vez
2 de octubre de 2020
Primero enviado que cumplió con los criterios de control de calidad
21 de octubre de 2020
Publicado por primera vez (Actual)
22 de octubre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Otro identificador: ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre COVID-19
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Ohio State UniversityReclutamientoSíndrome post-agudo de COVID19 | COVID largo | Condición posterior a COVID19Estados Unidos
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Texas Woman's UniversityNational Institutes of Health (NIH)Aún no reclutando
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Saglik Bilimleri Universitesi Gazi Yasargil Training...Terminado
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Fatima Memorial HospitalTerminado
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Cairo UniversityKasr El Aini HospitalDesconocido
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Assistance Publique - Hôpitaux de ParisDesconocido
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Brugmann University HospitalReclutamiento