Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21 oktober 2020 bijgewerkt door: 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).
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Clermont-Ferrand, Frankrijk, 63000
- CHU de Clermont-Ferrand
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Virological profile
Tijdsspanne: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Tijdsspanne: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Tijdsspanne: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Tijdsspanne: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Tijdsspanne: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Tijdsspanne: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tijdsspanne: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tijdsspanne: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tijdsspanne: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Tijdsspanne: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Tijdsspanne: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Tijdsspanne: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Tijdsspanne: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Tijdsspanne: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Tijdsspanne: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Tijdsspanne: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Tijdsspanne: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Tijdsspanne: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Tijdsspanne: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Tijdsspanne: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Tijdsspanne: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Tijdsspanne: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Tijdsspanne: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Tijdsspanne: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Tijdsspanne: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Tijdsspanne: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Tijdsspanne: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Tijdsspanne: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Tijdsspanne: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Tijdsspanne: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Tijdsspanne: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Tijdsspanne: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Tijdsspanne: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Tijdsspanne: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Tijdsspanne: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Tijdsspanne: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Tijdsspanne: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Tijdsspanne: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Tijdsspanne: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Tijdsspanne: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Tijdsspanne: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Tijdsspanne: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Tijdsspanne: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Tijdsspanne: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tijdsspanne: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tijdsspanne: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tijdsspanne: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Tijdsspanne: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tijdsspanne: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tijdsspanne: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tijdsspanne: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Tijdsspanne: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tijdsspanne: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tijdsspanne: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tijdsspanne: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Tijdsspanne: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tijdsspanne: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tijdsspanne: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tijdsspanne: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Tijdsspanne: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tijdsspanne: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tijdsspanne: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tijdsspanne: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Tijdsspanne: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Tijdsspanne: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Tijdsspanne: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Tijdsspanne: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Tijdsspanne: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Tijdsspanne: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Tijdsspanne: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Tijdsspanne: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Tijdsspanne: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Tijdsspanne: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Tijdsspanne: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Tijdsspanne: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Tijdsspanne: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Tijdsspanne: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Tijdsspanne: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Tijdsspanne: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Tijdsspanne: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tijdsspanne: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tijdsspanne: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tijdsspanne: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Tijdsspanne: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Tijdsspanne: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Tijdsspanne: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Tijdsspanne: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Tijdsspanne: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Tijdsspanne: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Tijdsspanne: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Tijdsspanne: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Tijdsspanne: Day 90
|
factor V in %
|
Day 90
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Tijdsspanne: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Tijdsspanne: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Tijdsspanne: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Tijdsspanne: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Tijdsspanne: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Tijdsspanne: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Tijdsspanne: 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
Tijdsspanne: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Tijdsspanne: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Tijdsspanne: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Tijdsspanne: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Tijdsspanne: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Tijdsspanne: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Tijdsspanne: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Tijdsspanne: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Tijdsspanne: day 10
|
body weight in kg
|
day 10
|
|
body weight
Tijdsspanne: day 21
|
body weight in kg
|
day 21
|
|
body weight
Tijdsspanne: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Tijdsspanne: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Tijdsspanne: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Tijdsspanne: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Tijdsspanne: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Tijdsspanne: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Tijdsspanne: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Tijdsspanne: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Tijdsspanne: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Tijdsspanne: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Tijdsspanne: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Tijdsspanne: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Tijdsspanne: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Tijdsspanne: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Tijdsspanne: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Tijdsspanne: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Tijdsspanne: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Tijdsspanne: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Tijdsspanne: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Tijdsspanne: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Tijdsspanne: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Tijdsspanne: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Tijdsspanne: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Tijdsspanne: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Tijdsspanne: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Tijdsspanne: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Tijdsspanne: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Tijdsspanne: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Tijdsspanne: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Tijdsspanne: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Tijdsspanne: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Tijdsspanne: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Tijdsspanne: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Tijdsspanne: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Tijdsspanne: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Tijdsspanne: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Tijdsspanne: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Tijdsspanne: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Tijdsspanne: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Tijdsspanne: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Tijdsspanne: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Tijdsspanne: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Tijdsspanne: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Tijdsspanne: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Tijdsspanne: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Tijdsspanne: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Tijdsspanne: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Tijdsspanne: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Tijdsspanne: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Tijdsspanne: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Tijdsspanne: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Tijdsspanne: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Tijdsspanne: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Tijdsspanne: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Tijdsspanne: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Tijdsspanne: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Tijdsspanne: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Tijdsspanne: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Tijdsspanne: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Tijdsspanne: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Tijdsspanne: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Tijdsspanne: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Tijdsspanne: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Tijdsspanne: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Tijdsspanne: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Tijdsspanne: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Tijdsspanne: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Tijdsspanne: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Tijdsspanne: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Tijdsspanne: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Tijdsspanne: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Tijdsspanne: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Tijdsspanne: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Tijdsspanne: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Tijdsspanne: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Tijdsspanne: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Tijdsspanne: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Tijdsspanne: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Tijdsspanne: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Tijdsspanne: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Tijdsspanne: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Tijdsspanne: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Tijdsspanne: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Tijdsspanne: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Tijdsspanne: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Tijdsspanne: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Tijdsspanne: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Tijdsspanne: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Tijdsspanne: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Tijdsspanne: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Tijdsspanne: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Tijdsspanne: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Tijdsspanne: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Tijdsspanne: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Tijdsspanne: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Tijdsspanne: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Tijdsspanne: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Tijdsspanne: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Tijdsspanne: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Tijdsspanne: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Tijdsspanne: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Tijdsspanne: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Tijdsspanne: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Tijdsspanne: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Tijdsspanne: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Céclie Henquell, University Hospital, Clermont-Ferrand
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 november 2020
Primaire voltooiing (Verwacht)
1 november 2021
Studie voltooiing (Verwacht)
1 februari 2022
Studieregistratiedata
Eerst ingediend
2 oktober 2020
Eerst ingediend dat voldeed aan de QC-criteria
21 oktober 2020
Eerst geplaatst (Werkelijk)
22 oktober 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 oktober 2020
Laatste update ingediend die voldeed aan QC-criteria
21 oktober 2020
Laatst geverifieerd
1 september 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Andere identificatie: ANSM)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .