Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21. října 2020 aktualizováno: 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).
Přehled studie
Postavení
Neznámý
Podmínky
Detailní popis
Subjects with a COVID-19 infection and thei contact cases (identification according to health insurance criteria, see "Améli.fr") will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel.
For the main objective: during the D0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine.
For secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative RT-PCR test on D0. A final consultation will be carried out at M3. Nasopharyngeal samples, saliva, blood, stool and urine will be taken on D10 and D21. A blood test will be taken at M3 to carry out a COVID-19 serology.
Typ studie
Intervenční
Zápis (Očekávaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Clermont-Ferrand, Francie, 63000
- CHU de Clermont-Ferrand
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: cohort
Biological collection with nasopharyngeal samples, saliva, blood, stool and urine
|
Subjects with a COVID-19 infection and their contact cases (identification according to health insurance criteria, see "Améli.fr") will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel. For the main objective: during the Day0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine. For secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative RT-PCR test on D0. A final consultation will be carried out at M3. Nasopharyngeal samples, saliva, blood, stool and urine will be taken on D10 and D21. A blood test will be taken at M3 to carry out a COVID-19 serology. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Virological profile
Časové okno: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Časové okno: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Časové okno: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Časové okno: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Časové okno: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Časové okno: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Časové okno: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Časové okno: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Časové okno: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Časové okno: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Časové okno: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Časové okno: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Časové okno: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Časové okno: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Časové okno: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Časové okno: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Časové okno: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Časové okno: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Časové okno: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Časové okno: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Časové okno: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Časové okno: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Časové okno: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Časové okno: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Časové okno: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Časové okno: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Časové okno: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Časové okno: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Časové okno: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Časové okno: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Časové okno: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Časové okno: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Časové okno: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Časové okno: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Časové okno: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Časové okno: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Časové okno: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Časové okno: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Časové okno: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Časové okno: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Časové okno: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Časové okno: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Časové okno: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Časové okno: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Časové okno: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Časové okno: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Časové okno: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Časové okno: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Časové okno: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Časové okno: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Časové okno: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Časové okno: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Časové okno: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Časové okno: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Časové okno: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Časové okno: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Časové okno: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Časové okno: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Časové okno: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Časové okno: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Časové okno: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Časové okno: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Časové okno: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Časové okno: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Časové okno: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Časové okno: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Časové okno: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Časové okno: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Časové okno: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Časové okno: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Časové okno: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Časové okno: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Časové okno: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Časové okno: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Časové okno: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Časové okno: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Časové okno: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Časové okno: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Časové okno: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Časové okno: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Časové okno: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Časové okno: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Časové okno: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Časové okno: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Časové okno: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Časové okno: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Časové okno: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Časové okno: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Časové okno: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Časové okno: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Časové okno: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Časové okno: Day 90
|
factor V in %
|
Day 90
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Časové okno: 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
Časové okno: 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
Časové okno: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Časové okno: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Časové okno: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Časové okno: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Časové okno: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Časové okno: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Časové okno: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Časové okno: 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
Časové okno: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Časové okno: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Časové okno: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Časové okno: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Časové okno: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Časové okno: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Časové okno: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Časové okno: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Časové okno: day 10
|
body weight in kg
|
day 10
|
|
body weight
Časové okno: day 21
|
body weight in kg
|
day 21
|
|
body weight
Časové okno: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Časové okno: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Časové okno: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Časové okno: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Časové okno: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Časové okno: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Časové okno: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Časové okno: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Časové okno: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Časové okno: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Časové okno: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Časové okno: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Časové okno: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Časové okno: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Časové okno: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Časové okno: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Časové okno: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Časové okno: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Časové okno: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Časové okno: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Časové okno: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Časové okno: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Časové okno: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Časové okno: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Časové okno: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Časové okno: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Časové okno: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Časové okno: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Časové okno: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Časové okno: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Časové okno: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Časové okno: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Časové okno: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Časové okno: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Časové okno: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Časové okno: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Časové okno: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Časové okno: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Časové okno: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Časové okno: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Časové okno: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Časové okno: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Časové okno: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Časové okno: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Časové okno: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Časové okno: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Časové okno: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Časové okno: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Časové okno: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Časové okno: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Časové okno: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Časové okno: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Časové okno: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Časové okno: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Časové okno: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Časové okno: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Časové okno: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Časové okno: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Časové okno: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Časové okno: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Časové okno: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Časové okno: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Časové okno: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Časové okno: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Časové okno: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Časové okno: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Časové okno: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Časové okno: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Časové okno: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Časové okno: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Časové okno: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Časové okno: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Časové okno: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Časové okno: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Časové okno: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Časové okno: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Časové okno: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Časové okno: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Časové okno: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Časové okno: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Časové okno: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Časové okno: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Časové okno: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Časové okno: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Časové okno: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Časové okno: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Časové okno: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Časové okno: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Časové okno: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Časové okno: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Časové okno: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Časové okno: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Časové okno: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Časové okno: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Časové okno: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Časové okno: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Časové okno: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Časové okno: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Časové okno: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Časové okno: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Časové okno: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Časové okno: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Časové okno: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Časové okno: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Časové okno: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Céclie Henquell, University Hospital, Clermont-Ferrand
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Očekávaný)
1. listopadu 2020
Primární dokončení (Očekávaný)
1. listopadu 2021
Dokončení studie (Očekávaný)
1. února 2022
Termíny zápisu do studia
První předloženo
2. října 2020
První předloženo, které splnilo kritéria kontroly kvality
21. října 2020
První zveřejněno (Aktuální)
22. října 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. října 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. října 2020
Naposledy ověřeno
1. září 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Jiný identifikátor: ANSM)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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