Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21 października 2020 zaktualizowane przez: 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).
Przegląd badań
Status
Nieznany
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
100
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Clermont-Ferrand, Francja, 63000
- CHU de Clermont-Ferrand
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Virological profile
Ramy czasowe: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Ramy czasowe: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Ramy czasowe: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Ramy czasowe: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Ramy czasowe: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Ramy czasowe: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Ramy czasowe: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Ramy czasowe: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Ramy czasowe: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Ramy czasowe: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Ramy czasowe: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Ramy czasowe: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Ramy czasowe: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Ramy czasowe: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Ramy czasowe: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Ramy czasowe: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Ramy czasowe: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Ramy czasowe: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Ramy czasowe: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Ramy czasowe: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Ramy czasowe: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Ramy czasowe: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Ramy czasowe: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Ramy czasowe: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Ramy czasowe: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Ramy czasowe: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Ramy czasowe: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Ramy czasowe: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Ramy czasowe: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Ramy czasowe: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Ramy czasowe: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Ramy czasowe: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Ramy czasowe: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Ramy czasowe: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Ramy czasowe: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Ramy czasowe: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Ramy czasowe: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Ramy czasowe: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Ramy czasowe: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Ramy czasowe: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Ramy czasowe: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Ramy czasowe: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Ramy czasowe: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Ramy czasowe: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Ramy czasowe: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Ramy czasowe: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Ramy czasowe: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Ramy czasowe: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Ramy czasowe: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Ramy czasowe: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Ramy czasowe: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Ramy czasowe: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Ramy czasowe: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Ramy czasowe: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Ramy czasowe: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Ramy czasowe: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Ramy czasowe: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Ramy czasowe: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Ramy czasowe: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Ramy czasowe: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Ramy czasowe: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Ramy czasowe: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Ramy czasowe: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Ramy czasowe: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Ramy czasowe: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Ramy czasowe: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Ramy czasowe: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Ramy czasowe: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Ramy czasowe: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Ramy czasowe: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Ramy czasowe: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Ramy czasowe: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Ramy czasowe: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Ramy czasowe: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Ramy czasowe: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Ramy czasowe: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Ramy czasowe: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Ramy czasowe: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Ramy czasowe: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Ramy czasowe: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Ramy czasowe: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Ramy czasowe: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Ramy czasowe: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Ramy czasowe: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Ramy czasowe: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Ramy czasowe: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Ramy czasowe: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Ramy czasowe: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Ramy czasowe: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Ramy czasowe: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Ramy czasowe: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Ramy czasowe: Day 90
|
factor V in %
|
Day 90
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Ramy czasowe: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Ramy czasowe: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Ramy czasowe: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Ramy czasowe: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Ramy czasowe: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Ramy czasowe: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Ramy czasowe: 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
Ramy czasowe: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Ramy czasowe: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Ramy czasowe: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Ramy czasowe: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Ramy czasowe: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Ramy czasowe: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Ramy czasowe: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Ramy czasowe: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Ramy czasowe: day 10
|
body weight in kg
|
day 10
|
|
body weight
Ramy czasowe: day 21
|
body weight in kg
|
day 21
|
|
body weight
Ramy czasowe: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Ramy czasowe: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Ramy czasowe: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Ramy czasowe: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Ramy czasowe: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Ramy czasowe: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Ramy czasowe: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Ramy czasowe: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Ramy czasowe: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Ramy czasowe: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Ramy czasowe: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Ramy czasowe: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Ramy czasowe: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Ramy czasowe: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Ramy czasowe: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Ramy czasowe: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Ramy czasowe: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Ramy czasowe: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Ramy czasowe: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Ramy czasowe: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Ramy czasowe: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Ramy czasowe: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Ramy czasowe: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Ramy czasowe: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Ramy czasowe: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Ramy czasowe: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Ramy czasowe: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Ramy czasowe: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Ramy czasowe: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Ramy czasowe: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Ramy czasowe: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Ramy czasowe: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Ramy czasowe: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Ramy czasowe: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Ramy czasowe: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Ramy czasowe: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Ramy czasowe: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Ramy czasowe: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Ramy czasowe: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Ramy czasowe: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Ramy czasowe: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Ramy czasowe: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Ramy czasowe: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Ramy czasowe: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Ramy czasowe: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Ramy czasowe: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Ramy czasowe: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Ramy czasowe: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Ramy czasowe: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Ramy czasowe: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Ramy czasowe: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Ramy czasowe: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Ramy czasowe: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Ramy czasowe: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Ramy czasowe: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Ramy czasowe: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Ramy czasowe: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Ramy czasowe: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Ramy czasowe: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Ramy czasowe: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Ramy czasowe: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Ramy czasowe: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Ramy czasowe: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Ramy czasowe: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Ramy czasowe: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Ramy czasowe: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Ramy czasowe: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Ramy czasowe: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Ramy czasowe: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Ramy czasowe: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Ramy czasowe: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Ramy czasowe: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Ramy czasowe: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Ramy czasowe: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Ramy czasowe: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Ramy czasowe: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Ramy czasowe: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Ramy czasowe: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Ramy czasowe: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Ramy czasowe: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Ramy czasowe: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Ramy czasowe: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Ramy czasowe: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Ramy czasowe: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Ramy czasowe: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Ramy czasowe: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Ramy czasowe: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Ramy czasowe: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Ramy czasowe: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Ramy czasowe: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Ramy czasowe: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Ramy czasowe: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Ramy czasowe: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Ramy czasowe: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Ramy czasowe: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Ramy czasowe: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Ramy czasowe: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Ramy czasowe: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Ramy czasowe: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Ramy czasowe: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Ramy czasowe: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Ramy czasowe: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Ramy czasowe: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Ramy czasowe: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Ramy czasowe: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Céclie Henquell, University Hospital, Clermont-Ferrand
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
1 listopada 2020
Zakończenie podstawowe (Oczekiwany)
1 listopada 2021
Ukończenie studiów (Oczekiwany)
1 lutego 2022
Daty rejestracji na studia
Pierwszy przesłany
2 października 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 października 2020
Pierwszy wysłany (Rzeczywisty)
22 października 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 października 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 października 2020
Ostatnia weryfikacja
1 września 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Inny identyfikator: ANSM)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .