Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21. oktober 2020 opdateret af: 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).
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Clermont-Ferrand, Frankrig, 63000
- CHU de Clermont-Ferrand
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Virological profile
Tidsramme: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Tidsramme: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Tidsramme: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Tidsramme: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Tidsramme: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Tidsramme: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tidsramme: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tidsramme: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tidsramme: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tidsramme: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Tidsramme: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Tidsramme: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Tidsramme: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Tidsramme: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Tidsramme: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Tidsramme: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Tidsramme: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Tidsramme: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Tidsramme: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Tidsramme: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Tidsramme: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Tidsramme: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Tidsramme: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Tidsramme: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Tidsramme: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Tidsramme: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Tidsramme: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Tidsramme: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Tidsramme: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Tidsramme: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Tidsramme: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Tidsramme: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Tidsramme: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Tidsramme: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Tidsramme: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Tidsramme: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Tidsramme: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Tidsramme: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Tidsramme: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Tidsramme: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Tidsramme: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Tidsramme: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Tidsramme: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Tidsramme: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tidsramme: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tidsramme: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tidsramme: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tidsramme: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tidsramme: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tidsramme: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tidsramme: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tidsramme: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tidsramme: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tidsramme: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tidsramme: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tidsramme: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tidsramme: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tidsramme: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tidsramme: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tidsramme: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tidsramme: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tidsramme: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tidsramme: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tidsramme: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Tidsramme: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Tidsramme: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Tidsramme: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Tidsramme: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Tidsramme: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Tidsramme: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Tidsramme: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Tidsramme: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Tidsramme: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Tidsramme: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Tidsramme: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Tidsramme: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Tidsramme: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Tidsramme: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Tidsramme: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Tidsramme: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tidsramme: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tidsramme: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tidsramme: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tidsramme: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Tidsramme: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Tidsramme: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Tidsramme: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Tidsramme: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Tidsramme: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Tidsramme: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Tidsramme: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Tidsramme: Day 90
|
factor V in %
|
Day 90
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Tidsramme: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Tidsramme: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Tidsramme: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Tidsramme: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Tidsramme: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Tidsramme: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Tidsramme: 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
Tidsramme: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Tidsramme: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Tidsramme: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Tidsramme: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Tidsramme: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Tidsramme: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Tidsramme: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Tidsramme: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Tidsramme: day 10
|
body weight in kg
|
day 10
|
|
body weight
Tidsramme: day 21
|
body weight in kg
|
day 21
|
|
body weight
Tidsramme: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Tidsramme: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Tidsramme: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Tidsramme: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Tidsramme: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Tidsramme: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Tidsramme: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Tidsramme: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Tidsramme: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Tidsramme: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Tidsramme: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Tidsramme: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Tidsramme: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Tidsramme: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Tidsramme: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Tidsramme: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Tidsramme: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Tidsramme: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Tidsramme: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Tidsramme: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Tidsramme: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Tidsramme: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Tidsramme: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Tidsramme: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Tidsramme: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Tidsramme: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Tidsramme: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Tidsramme: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Tidsramme: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Tidsramme: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Tidsramme: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Tidsramme: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Tidsramme: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Tidsramme: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Tidsramme: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Tidsramme: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Tidsramme: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Tidsramme: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Tidsramme: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Tidsramme: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Tidsramme: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Tidsramme: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Tidsramme: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Tidsramme: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Tidsramme: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Tidsramme: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Tidsramme: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Tidsramme: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Tidsramme: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Tidsramme: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Tidsramme: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Tidsramme: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Tidsramme: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Tidsramme: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Tidsramme: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Tidsramme: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Tidsramme: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Tidsramme: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Tidsramme: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Tidsramme: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Tidsramme: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Tidsramme: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Tidsramme: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Tidsramme: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Tidsramme: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Tidsramme: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Tidsramme: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Tidsramme: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Tidsramme: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Tidsramme: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Tidsramme: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Tidsramme: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Tidsramme: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Tidsramme: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Tidsramme: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Tidsramme: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Tidsramme: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Tidsramme: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Tidsramme: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Tidsramme: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Tidsramme: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Tidsramme: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Tidsramme: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Tidsramme: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Tidsramme: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Tidsramme: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Tidsramme: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Tidsramme: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Tidsramme: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Tidsramme: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Tidsramme: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Tidsramme: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Tidsramme: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Tidsramme: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Tidsramme: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Tidsramme: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Tidsramme: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Tidsramme: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Tidsramme: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Tidsramme: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Tidsramme: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Tidsramme: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Tidsramme: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Tidsramme: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Tidsramme: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Céclie Henquell, University Hospital, Clermont-Ferrand
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. november 2020
Primær færdiggørelse (Forventet)
1. november 2021
Studieafslutning (Forventet)
1. februar 2022
Datoer for studieregistrering
Først indsendt
2. oktober 2020
Først indsendt, der opfyldte QC-kriterier
21. oktober 2020
Først opslået (Faktiske)
22. oktober 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. oktober 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Anden identifikator: ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Covid19
-
Anavasi DiagnosticsIkke rekrutterer endnu
-
Ain Shams UniversityRekruttering
-
Israel Institute for Biological Research (IIBR)Afsluttet
-
Colgate PalmoliveAfsluttet
-
Christian von BuchwaldAfsluttet
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdAktiv, ikke rekrutterende
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitatsspital ZurichTilmelding efter invitation
-
Alexandria UniversityAfsluttet
-
Henry Ford Health SystemAfsluttet