Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21. Oktober 2020 aktualisiert von: 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).
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
100
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Clermont-Ferrand, Frankreich, 63000
- CHU de Clermont-Ferrand
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Virological profile
Zeitfenster: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Zeitfenster: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Zeitfenster: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Zeitfenster: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Zeitfenster: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Zeitfenster: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Zeitfenster: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Zeitfenster: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Zeitfenster: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Zeitfenster: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Zeitfenster: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Zeitfenster: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Zeitfenster: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Zeitfenster: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Zeitfenster: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Zeitfenster: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Zeitfenster: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Zeitfenster: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Zeitfenster: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Zeitfenster: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Zeitfenster: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Zeitfenster: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Zeitfenster: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Zeitfenster: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Zeitfenster: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Zeitfenster: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Zeitfenster: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Zeitfenster: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Zeitfenster: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Zeitfenster: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Zeitfenster: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Zeitfenster: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Zeitfenster: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Zeitfenster: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Zeitfenster: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Zeitfenster: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Zeitfenster: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Zeitfenster: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Zeitfenster: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Zeitfenster: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Zeitfenster: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Zeitfenster: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Zeitfenster: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Zeitfenster: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Zeitfenster: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Zeitfenster: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Zeitfenster: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Zeitfenster: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Zeitfenster: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Zeitfenster: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Zeitfenster: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Zeitfenster: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Zeitfenster: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Zeitfenster: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Zeitfenster: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Zeitfenster: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Zeitfenster: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Zeitfenster: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Zeitfenster: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Zeitfenster: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Zeitfenster: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Zeitfenster: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Zeitfenster: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Zeitfenster: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Zeitfenster: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Zeitfenster: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Zeitfenster: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Zeitfenster: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Zeitfenster: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Zeitfenster: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Zeitfenster: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Zeitfenster: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Zeitfenster: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Zeitfenster: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Zeitfenster: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Zeitfenster: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Zeitfenster: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Zeitfenster: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Zeitfenster: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Zeitfenster: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Zeitfenster: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Zeitfenster: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Zeitfenster: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Zeitfenster: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Zeitfenster: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Zeitfenster: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Zeitfenster: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Zeitfenster: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Zeitfenster: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Zeitfenster: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Zeitfenster: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Zeitfenster: Day 90
|
factor V in %
|
Day 90
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Zeitfenster: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Zeitfenster: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Zeitfenster: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Zeitfenster: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Zeitfenster: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Zeitfenster: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Zeitfenster: 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
Zeitfenster: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Zeitfenster: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Zeitfenster: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Zeitfenster: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Zeitfenster: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Zeitfenster: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Zeitfenster: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Zeitfenster: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Zeitfenster: day 10
|
body weight in kg
|
day 10
|
|
body weight
Zeitfenster: day 21
|
body weight in kg
|
day 21
|
|
body weight
Zeitfenster: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Zeitfenster: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Zeitfenster: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Zeitfenster: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Zeitfenster: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Zeitfenster: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Zeitfenster: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Zeitfenster: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Zeitfenster: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Zeitfenster: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Zeitfenster: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Zeitfenster: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Zeitfenster: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Zeitfenster: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Zeitfenster: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Zeitfenster: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Zeitfenster: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Zeitfenster: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Zeitfenster: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Zeitfenster: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Zeitfenster: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Zeitfenster: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Zeitfenster: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Zeitfenster: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Zeitfenster: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Zeitfenster: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Zeitfenster: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Zeitfenster: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Zeitfenster: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Zeitfenster: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Zeitfenster: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Zeitfenster: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Zeitfenster: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Zeitfenster: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Zeitfenster: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Zeitfenster: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Zeitfenster: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Zeitfenster: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Zeitfenster: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Zeitfenster: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Zeitfenster: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Zeitfenster: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Zeitfenster: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Zeitfenster: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Zeitfenster: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Zeitfenster: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Zeitfenster: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Zeitfenster: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Zeitfenster: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Zeitfenster: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Zeitfenster: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Zeitfenster: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Zeitfenster: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Zeitfenster: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Zeitfenster: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Zeitfenster: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Zeitfenster: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Zeitfenster: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Zeitfenster: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Zeitfenster: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Zeitfenster: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Zeitfenster: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Zeitfenster: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Zeitfenster: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Zeitfenster: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Zeitfenster: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Zeitfenster: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Zeitfenster: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Zeitfenster: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Zeitfenster: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Zeitfenster: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Zeitfenster: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Zeitfenster: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Zeitfenster: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Zeitfenster: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Zeitfenster: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Zeitfenster: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Zeitfenster: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Zeitfenster: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Zeitfenster: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Zeitfenster: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Zeitfenster: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Zeitfenster: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Zeitfenster: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Zeitfenster: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Zeitfenster: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Zeitfenster: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Zeitfenster: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Zeitfenster: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Zeitfenster: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Zeitfenster: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Zeitfenster: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Zeitfenster: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Zeitfenster: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Zeitfenster: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Zeitfenster: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Zeitfenster: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Zeitfenster: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Zeitfenster: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Zeitfenster: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Zeitfenster: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Zeitfenster: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Zeitfenster: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Zeitfenster: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Zeitfenster: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Céclie Henquell, University Hospital, Clermont-Ferrand
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. November 2020
Primärer Abschluss (Voraussichtlich)
1. November 2021
Studienabschluss (Voraussichtlich)
1. Februar 2022
Studienanmeldedaten
Zuerst eingereicht
2. Oktober 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Oktober 2020
Zuerst gepostet (Tatsächlich)
22. Oktober 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Oktober 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Oktober 2020
Zuletzt verifiziert
1. September 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Andere Kennung: ANSM)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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