Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)
21 ottobre 2020 aggiornato da: 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).
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Clermont-Ferrand, Francia, 63000
- CHU de Clermont-Ferrand
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Virological profile
Lasso di tempo: Day 0
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 0
|
|
Virological profile
Lasso di tempo: Day 10
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 10
|
|
Virological profile
Lasso di tempo: Day 21
|
Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)
|
Day 21
|
|
Virological profile (serology)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 0
|
CRP in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of CRP
Lasso di tempo: Day 10
|
CRP in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of CRP
Lasso di tempo: Day 21
|
CRP in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of CRP
Lasso di tempo: Day 90
|
CRP in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Lasso di tempo: Day 0
|
ASAT/ALAT in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Lasso di tempo: Day 10
|
ASAT/ALAT in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Lasso di tempo: Day 21
|
ASAT/ALAT in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of ASAT/ALAT
Lasso di tempo: Day 90
|
ASAT/ALAT in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of LDH
Lasso di tempo: Day 0
|
LDH in U/L
|
Day 0
|
|
Biochemical profile by blood dosage of LDH
Lasso di tempo: Day 10
|
LDH in U/L
|
Day 10
|
|
Biochemical profile by blood dosage of LDH
Lasso di tempo: Day 21
|
LDH in U/L
|
Day 21
|
|
Biochemical profile by blood dosage of LDH
Lasso di tempo: Day 90
|
LDH in U/L
|
Day 90
|
|
Biochemical profile by blood dosage of Lactate
Lasso di tempo: Day 0
|
Lactate in mg/l
|
Day 0
|
|
Biochemical profile by blood dosage of Lactate
Lasso di tempo: Day 10
|
Lactate in mg/l
|
Day 10
|
|
Biochemical profile by blood dosage of Lactate
Lasso di tempo: Day 21
|
Lactate in mg/l
|
Day 21
|
|
Biochemical profile by blood dosage of Lactate
Lasso di tempo: Day 90
|
Lactate in mg/l
|
Day 90
|
|
Biochemical profile by blood dosage of D-Dimer
Lasso di tempo: Day 0
|
D-Dimer in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of D-Dimer
Lasso di tempo: Day 10
|
D-Dimer in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of D-Dimer
Lasso di tempo: Day 21
|
D-Dimer in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of D-Dimer
Lasso di tempo: Day 90
|
D-Dimer in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Troponin
Lasso di tempo: Day 0
|
Troponin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Troponin
Lasso di tempo: Day 10
|
Troponin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Troponin
Lasso di tempo: Day 21
|
Troponin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of Troponin
Lasso di tempo: Day 90
|
Troponin in µg/L
|
Day 90
|
|
Biochemical profile by blood dosage of Ferritin
Lasso di tempo: Day 0
|
Ferritin in µg/L
|
Day 0
|
|
Biochemical profile by blood dosage of Ferritin
Lasso di tempo: Day 10
|
Ferritin in µg/L
|
Day 10
|
|
Biochemical profile by blood dosage of Ferritin
Lasso di tempo: Day 21
|
Ferritin in µg/L
|
Day 21
|
|
Biochemical profile by blood dosage of RAGE
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 0
|
leukocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of leukocytes
Lasso di tempo: Day 10
|
leukocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of leukocytes
Lasso di tempo: Day 21
|
leukocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of leukocytes
Lasso di tempo: Day 90
|
leukocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of Red blood cells
Lasso di tempo: Day 0
|
Red blood cells in Tera/L
|
Day 0
|
|
Haematological profile by blood dosage of Red blood cells
Lasso di tempo: Day 10
|
Red blood cells in Tera/L
|
Day 10
|
|
Haematological profile by blood dosage of Red blood cells
Lasso di tempo: Day 21
|
Red blood cells in Tera/L
|
Day 21
|
|
Haematological profile by blood dosage of Red blood cells
Lasso di tempo: Day 90
|
Red blood cells in Tera/L
|
Day 90
|
|
Haematological profile by blood dosage of Hemoglobin
Lasso di tempo: Day 0
|
Hemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of Hemoglobin
Lasso di tempo: Day 10
|
Hemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of Hemoglobin
Lasso di tempo: Day 21
|
Hemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of Hemoglobin
Lasso di tempo: Day 90
|
Hemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of Hematocrit
Lasso di tempo: Day 0
|
Hematocrit in %
|
Day 0
|
|
Haematological profile by blood dosage of Hematocrit
Lasso di tempo: Day 10
|
Hematocrit in %
|
Day 10
|
|
Haematological profile by blood dosage of Hematocrit
Lasso di tempo: Day 21
|
Hematocrit in %
|
Day 21
|
|
Haematological profile by blood dosage of Hematocrit
Lasso di tempo: Day 90
|
Hematocrit in %
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Lasso di tempo: Day 0
|
Mean corpuscular volume in fL
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Lasso di tempo: Day 10
|
Mean corpuscular volume in fL
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Lasso di tempo: Day 21
|
Mean corpuscular volume in fL
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular volume
Lasso di tempo: Day 90
|
Mean corpuscular volume in fL
|
Day 90
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Lasso di tempo: Day 0
|
Mean corpuscular hemoglobin in pg
|
Day 0
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Lasso di tempo: Day 10
|
Mean corpuscular hemoglobin in pg
|
Day 10
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Lasso di tempo: Day 21
|
Mean corpuscular hemoglobin in pg
|
Day 21
|
|
Haematological profile by blood dosage of Mean corpuscular hemoglobin
Lasso di tempo: Day 90
|
Mean corpuscular hemoglobin in pg
|
Day 90
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Lasso di tempo: Day 0
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 0
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Lasso di tempo: Day 10
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 10
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Lasso di tempo: Day 21
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 21
|
|
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
Lasso di tempo: Day 90
|
Average corpuscular concentration of haemoglobin in g/dL
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Lasso di tempo: Day 0
|
polynuclear neutrophil in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Lasso di tempo: Day 10
|
polynuclear neutrophil in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Lasso di tempo: Day 21
|
polynuclear neutrophil in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear neutrophil
Lasso di tempo: Day 90
|
polynuclear neutrophil in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Lasso di tempo: Day 0
|
polynuclear eosinophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Lasso di tempo: Day 10
|
polynuclear eosinophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Lasso di tempo: Day 21
|
polynuclear eosinophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear eosinophils
Lasso di tempo: Day 90
|
polynuclear eosinophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of polynuclear basophils
Lasso di tempo: Day 0
|
polynuclear basophils in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of polynuclear basophils
Lasso di tempo: Day 10
|
polynuclear basophils in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of polynuclear basophils
Lasso di tempo: Day 21
|
polynuclear basophils in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of polynuclear basophils
Lasso di tempo: Day 90
|
polynuclear basophils in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of lymphocytes
Lasso di tempo: Day 0
|
lymphocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of lymphocytes
Lasso di tempo: Day 10
|
lymphocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of lymphocytes
Lasso di tempo: Day 21
|
lymphocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of lymphocytes
Lasso di tempo: Day 90
|
lymphocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Lasso di tempo: Day 90
|
monocytes in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of monocytes
Lasso di tempo: Day 0
|
monocytes in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of monocytes
Lasso di tempo: Day 10
|
monocytes in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of monocytes
Lasso di tempo: Day 21
|
monocytes in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Lasso di tempo: Day 0
|
platelets in Giga/L
|
Day 0
|
|
Haematological profile by blood dosage of platelets
Lasso di tempo: Day 10
|
platelets in Giga/L
|
Day 10
|
|
Haematological profile by blood dosage of platelets
Lasso di tempo: Day 21
|
platelets in Giga/L
|
Day 21
|
|
Haematological profile by blood dosage of platelets
Lasso di tempo: Day 90
|
platelets in Giga/L
|
Day 90
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Lasso di tempo: Day 0
|
activated partial thromboplastin time in second/witness
|
Day 0
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Lasso di tempo: Day 10
|
activated partial thromboplastin time in second/witness
|
Day 10
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Lasso di tempo: Day 21
|
activated partial thromboplastin time in second/witness
|
Day 21
|
|
Haematological profile by blood dosage of activated partial thromboplastin time
Lasso di tempo: Day 90
|
activated partial thromboplastin time in second/witness
|
Day 90
|
|
Haematological profile by blood dosage of fibrinogen
Lasso di tempo: Day 0
|
fibrinogen in g/L
|
Day 0
|
|
Haematological profile by blood dosage of fibrinogen
Lasso di tempo: Day 10
|
fibrinogen in g/L
|
Day 10
|
|
Haematological profile by blood dosage of fibrinogen
Lasso di tempo: Day 21
|
fibrinogen in g/L
|
Day 21
|
|
Haematological profile by blood dosage of fibrinogen
Lasso di tempo: Day 90
|
fibrinogen in g/L
|
Day 90
|
|
Haematological profile by blood dosage of factor V
Lasso di tempo: Day 0
|
factor V in %
|
Day 0
|
|
Haematological profile by blood dosage of factor V
Lasso di tempo: Day 10
|
factor V in %
|
Day 10
|
|
Haematological profile by blood dosage of factor V
Lasso di tempo: Day 21
|
factor V in %
|
Day 21
|
|
Haematological profile by blood dosage of factor V
Lasso di tempo: Day 90
|
factor V in %
|
Day 90
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
SARS-CoV-2 salivary viral load
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day 21
|
RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL
|
Day 21
|
|
Comparison of viral sequences
Lasso di tempo: Day 0
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 0
|
|
Comparison of viral sequences
Lasso di tempo: Day 10
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 10
|
|
Comparison of viral sequences
Lasso di tempo: Day 21
|
bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)
|
Day 21
|
|
microbiota analysis
Lasso di tempo: Day 0
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 0
|
|
microbiota analysis
Lasso di tempo: Day 10
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 10
|
|
microbiota analysis
Lasso di tempo: Day 21
|
bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)
|
Day 21
|
|
environmental and societal factors (EPICE)
Lasso di tempo: 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
Lasso di tempo: Day 0
|
eating habits
|
Day 0
|
|
environmental and societal factors
Lasso di tempo: day 10
|
eating habits
|
day 10
|
|
environmental and societal factors
Lasso di tempo: day 21
|
eating habits
|
day 21
|
|
environmental and societal factors
Lasso di tempo: day 90
|
eating habits
|
day 90
|
|
environmental and societal factors (SF-36)
Lasso di tempo: Day 0
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
Day 0
|
|
environmental and societal factors (SF-36)
Lasso di tempo: day 10
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 10
|
|
environmental and societal factors (SF-36)
Lasso di tempo: day 21
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 21
|
|
environmental and societal factors (SF-36)
Lasso di tempo: day 90
|
SF-36 score (quality of life by Gardenal O) from 0 to 100
|
day 90
|
|
environmental and societal factors (Physical activity)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Day 0
|
body weight in kg
|
Day 0
|
|
body weight
Lasso di tempo: day 10
|
body weight in kg
|
day 10
|
|
body weight
Lasso di tempo: day 21
|
body weight in kg
|
day 21
|
|
body weight
Lasso di tempo: day 90
|
body weight in kg
|
day 90
|
|
oxygen saturation
Lasso di tempo: Day 0
|
oxygen saturation in %
|
Day 0
|
|
oxygen saturation
Lasso di tempo: day 10
|
oxygen saturation in %
|
day 10
|
|
oxygen saturation
Lasso di tempo: day 21
|
oxygen saturation in %
|
day 21
|
|
oxygen saturation
Lasso di tempo: day 90
|
oxygen saturation in %
|
day 90
|
|
Respiratory rate
Lasso di tempo: Day 0
|
Respiratory rate per minute
|
Day 0
|
|
Respiratory rate
Lasso di tempo: day 10
|
Respiratory rate per minute
|
day 10
|
|
Respiratory rate
Lasso di tempo: day 21
|
Respiratory rate per minute
|
day 21
|
|
Respiratory rate
Lasso di tempo: day 90
|
Respiratory rate per minute
|
day 90
|
|
cardiac frequency
Lasso di tempo: Day 0
|
cardiac frequency per minute
|
Day 0
|
|
cardiac frequency
Lasso di tempo: day 10
|
cardiac frequency per minute
|
day 10
|
|
cardiac frequency
Lasso di tempo: day 21
|
cardiac frequency per minute
|
day 21
|
|
cardiac frequency
Lasso di tempo: day 90
|
cardiac frequency per minute
|
day 90
|
|
lung damage
Lasso di tempo: Day 0
|
Lung damage on auscultation in terms of presence/absence
|
Day 0
|
|
lung damage
Lasso di tempo: day 10
|
Lung damage on auscultation in terms of presence/absence
|
day 10
|
|
lung damage
Lasso di tempo: day 21
|
Lung damage on auscultation in terms of presence/absence
|
day 21
|
|
lung damage
Lasso di tempo: day 90
|
Lung damage on auscultation in terms of presence/absence
|
day 90
|
|
lung evolution
Lasso di tempo: day 90
|
CT san in terms of normal/abnormal (children and pregnant women not concerned)
|
day 90
|
|
blood pressure
Lasso di tempo: Day 0
|
Dysatolic/systolic blood pressure in mmHg
|
Day 0
|
|
blood pressure
Lasso di tempo: day 10
|
Dysatolic/systolic blood pressure in mmHg
|
day 10
|
|
blood pressure
Lasso di tempo: day 21
|
Dysatolic/systolic blood pressure in mmHg
|
day 21
|
|
blood pressure
Lasso di tempo: day 90
|
Dysatolic/systolic blood pressure in mmHg
|
day 90
|
|
body temperature
Lasso di tempo: Day 0
|
Body temperature in °C
|
Day 0
|
|
body temperature
Lasso di tempo: day 10
|
Body temperature in °C
|
day 10
|
|
body temperature
Lasso di tempo: day 21
|
Body temperature in °C
|
day 21
|
|
body temperature
Lasso di tempo: day 90
|
Body temperature in °C
|
day 90
|
|
clinical exam (skin)
Lasso di tempo: Day 0
|
Skin mottling in terms of presence/absence
|
Day 0
|
|
clinical exam (skin)
Lasso di tempo: day 10
|
Skin mottling in terms of presence/absence
|
day 10
|
|
clinical exam (skin)
Lasso di tempo: day 21
|
Skin mottling in terms of presence/absence
|
day 21
|
|
clinical exam (skin)
Lasso di tempo: day 90
|
Skin mottling in terms of presence/absence
|
day 90
|
|
clinical exam (polypnea)
Lasso di tempo: Day 0
|
polypnea in terms of presence/absence
|
Day 0
|
|
clinical exam (polypnea)
Lasso di tempo: day 10
|
polypnea in terms of presence/absence
|
day 10
|
|
clinical exam (polypnea)
Lasso di tempo: day 21
|
polypnea in terms of presence/absence
|
day 21
|
|
clinical exam (polypnea)
Lasso di tempo: day 90
|
polypnea in terms of presence/absence
|
day 90
|
|
denutrition
Lasso di tempo: Day 0
|
denutrition in terms of presence/absence
|
Day 0
|
|
denutrition
Lasso di tempo: day 10
|
denutrition in terms of presence/absence
|
day 10
|
|
denutrition
Lasso di tempo: day 21
|
denutrition in terms of presence/absence
|
day 21
|
|
denutrition
Lasso di tempo: day 90
|
denutrition in terms of presence/absence
|
day 90
|
|
Antibiotic treatment
Lasso di tempo: Day 0
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Antibiotic treatment
Lasso di tempo: day 10
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Antibiotic treatment
Lasso di tempo: day 21
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Antibiotic treatment
Lasso di tempo: day 90
|
Antibiotic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Steroidal anti-inflammatory treatment
Lasso di tempo: Day 0
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Steroidal anti-inflammatory treatment
Lasso di tempo: day 10
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Steroidal anti-inflammatory treatment
Lasso di tempo: day 21
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Steroidal anti-inflammatory treatment
Lasso di tempo: day 90
|
Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Anti-diabetic treatment
Lasso di tempo: Day 0
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Anti-diabetic treatment
Lasso di tempo: day 10
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Anti-diabetic treatment
Lasso di tempo: day 21
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Anti-diabetic treatment
Lasso di tempo: day 90
|
Anti-diabetic treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
Gastric protector treatment
Lasso di tempo: Day 0
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
Day 0
|
|
Gastric protector treatment
Lasso di tempo: day 10
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 10
|
|
Gastric protector treatment
Lasso di tempo: day 21
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 21
|
|
Gastric protector treatment
Lasso di tempo: day 90
|
Gastric protector treatment in terms of presence/absence with precision if necessary
|
day 90
|
|
chills
Lasso di tempo: Day 0
|
chills in terms of presence/absence
|
Day 0
|
|
chills
Lasso di tempo: day 10
|
chills in terms of presence/absence
|
day 10
|
|
chills
Lasso di tempo: day 21
|
chills in terms of presence/absence
|
day 21
|
|
chills
Lasso di tempo: day 90
|
chills in terms of presence/absence
|
day 90
|
|
Myalgia
Lasso di tempo: Day 0
|
Myalgia in terms of presence/absence
|
Day 0
|
|
Myalgia
Lasso di tempo: day 10
|
Myalgia in terms of presence/absence
|
day 10
|
|
Myalgia
Lasso di tempo: day 21
|
Myalgia in terms of presence/absence
|
day 21
|
|
Myalgia
Lasso di tempo: day 90
|
Myalgia in terms of presence/absence
|
day 90
|
|
Anorexia
Lasso di tempo: Day 0
|
Anorexia in terms of presence/absence
|
Day 0
|
|
Anorexia
Lasso di tempo: day 10
|
Anorexia in terms of presence/absence
|
day 10
|
|
Anorexia
Lasso di tempo: day 21
|
Anorexia in terms of presence/absence
|
day 21
|
|
Anorexia
Lasso di tempo: day 90
|
Anorexia in terms of presence/absence
|
day 90
|
|
Rhinitis
Lasso di tempo: Day 0
|
Rhinitis in terms of presence/absence
|
Day 0
|
|
Rhinitis
Lasso di tempo: day 10
|
Rhinitis in terms of presence/absence
|
day 10
|
|
Rhinitis
Lasso di tempo: day 21
|
Rhinitis in terms of presence/absence
|
day 21
|
|
Rhinitis
Lasso di tempo: day 90
|
Rhinitis in terms of presence/absence
|
day 90
|
|
Confusion
Lasso di tempo: Day 0
|
Confusion in terms of presence/absence
|
Day 0
|
|
Confusion
Lasso di tempo: day 10
|
Confusion in terms of presence/absence
|
day 10
|
|
Confusion
Lasso di tempo: day 21
|
Confusion in terms of presence/absence
|
day 21
|
|
Confusion
Lasso di tempo: day 90
|
Confusion in terms of presence/absence
|
day 90
|
|
Asthenia
Lasso di tempo: Day 0
|
Asthenia in terms of presence/absence
|
Day 0
|
|
Asthenia
Lasso di tempo: day 10
|
Asthenia in terms of presence/absence
|
day 10
|
|
Asthenia
Lasso di tempo: day 21
|
Asthenia in terms of presence/absence
|
day 21
|
|
Asthenia
Lasso di tempo: day 90
|
Asthenia in terms of presence/absence
|
day 90
|
|
Falls at home
Lasso di tempo: Day 0
|
Falls at home in terms of presence/absence
|
Day 0
|
|
Falls at home
Lasso di tempo: day 10
|
Falls at home in terms of presence/absence
|
day 10
|
|
Falls at home
Lasso di tempo: day 21
|
Falls at home in terms of presence/absence
|
day 21
|
|
Falls at home
Lasso di tempo: day 90
|
Falls at home in terms of presence/absence
|
day 90
|
|
Insomnia
Lasso di tempo: Day 0
|
Insomnia in terms of presence/absence
|
Day 0
|
|
Insomnia
Lasso di tempo: day 10
|
Insomnia in terms of presence/absence
|
day 10
|
|
Insomnia
Lasso di tempo: day 21
|
Insomnia in terms of presence/absence
|
day 21
|
|
Insomnia
Lasso di tempo: day 90
|
Insomnia in terms of presence/absence
|
day 90
|
|
Angina
Lasso di tempo: Day 0
|
Angina in terms of presence/absence
|
Day 0
|
|
Angina
Lasso di tempo: day 10
|
Angina in terms of presence/absence
|
day 10
|
|
Angina
Lasso di tempo: day 21
|
Angina in terms of presence/absence
|
day 21
|
|
Angina
Lasso di tempo: day 90
|
Angina in terms of presence/absence
|
day 90
|
|
Ageusia
Lasso di tempo: Day 0
|
Ageusia in terms of presence/absence
|
Day 0
|
|
Ageusia
Lasso di tempo: day 10
|
Ageusia in terms of presence/absence
|
day 10
|
|
Ageusia
Lasso di tempo: day 21
|
Ageusia in terms of presence/absence
|
day 21
|
|
Ageusia
Lasso di tempo: day 90
|
Ageusia in terms of presence/absence
|
day 90
|
|
Respiratory complaints
Lasso di tempo: Day 0
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
Day 0
|
|
Respiratory complaints
Lasso di tempo: day 2
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 2
|
|
Respiratory complaints
Lasso di tempo: day 4
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 4
|
|
Respiratory complaints
Lasso di tempo: day 6
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 6
|
|
Respiratory complaints
Lasso di tempo: day 8
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 8
|
|
Respiratory complaints
Lasso di tempo: day 10
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 10
|
|
Respiratory complaints
Lasso di tempo: day 21
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 21
|
|
Respiratory complaints
Lasso di tempo: day 90
|
Respiratory complaints in term of SRIpr score from 0 to 100
|
day 90
|
|
transmission rate
Lasso di tempo: Day 0
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
Day 0
|
|
transmission rate
Lasso di tempo: day 10
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 10
|
|
transmission rate
Lasso di tempo: day 21
|
Rate of viral transmission determine by bioinformatic and statistical analyzes in %
|
day 21
|
|
prolonged viral shedding
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Céclie Henquell, University Hospital, Clermont-Ferrand
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 novembre 2020
Completamento primario (Anticipato)
1 novembre 2021
Completamento dello studio (Anticipato)
1 febbraio 2022
Date di iscrizione allo studio
Primo inviato
2 ottobre 2020
Primo inviato che soddisfa i criteri di controllo qualità
21 ottobre 2020
Primo Inserito (Effettivo)
22 ottobre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 ottobre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 ottobre 2020
Ultimo verificato
1 settembre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RBPH 2020 HENQUELL
- 2020-A02381-38 (Altro identificatore: ANSM)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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