Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) (COVIDCOLLECT)

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).

Study Overview

• Status: Unknown
• Conditions: Covid19; Contact Case
• Intervention / Treatment: Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: cohort; Biological collection with nasopharyngeal samples, saliva, blood, stool and urine

Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virological profile	Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)	Day 0
Virological profile	Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)	Day 10
Virological profile	Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)	Day 21
Virological profile (serology)	SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)	Day 0
Virological profile (serology)	SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)	Day 10
Virological profile (serology)	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)	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)	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)	cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL	Day 21
Immunological profile with blood level for markers of inflammation	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	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	markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %	Day 21
Biochemical profile by blood dosage of CRP	CRP in mg/l	Day 0
Biochemical profile by blood dosage of CRP	CRP in mg/l	Day 10
Biochemical profile by blood dosage of CRP	CRP in mg/l	Day 21
Biochemical profile by blood dosage of CRP	CRP in mg/l	Day 90
Biochemical profile by blood dosage of ASAT/ALAT	ASAT/ALAT in U/L	Day 0
Biochemical profile by blood dosage of ASAT/ALAT	ASAT/ALAT in U/L	Day 10
Biochemical profile by blood dosage of ASAT/ALAT	ASAT/ALAT in U/L	Day 21
Biochemical profile by blood dosage of ASAT/ALAT	ASAT/ALAT in U/L	Day 90
Biochemical profile by blood dosage of LDH	LDH in U/L	Day 0
Biochemical profile by blood dosage of LDH	LDH in U/L	Day 10
Biochemical profile by blood dosage of LDH	LDH in U/L	Day 21
Biochemical profile by blood dosage of LDH	LDH in U/L	Day 90
Biochemical profile by blood dosage of Lactate	Lactate in mg/l	Day 0
Biochemical profile by blood dosage of Lactate	Lactate in mg/l	Day 10
Biochemical profile by blood dosage of Lactate	Lactate in mg/l	Day 21
Biochemical profile by blood dosage of Lactate	Lactate in mg/l	Day 90
Biochemical profile by blood dosage of D-Dimer	D-Dimer in µg/L	Day 0
Biochemical profile by blood dosage of D-Dimer	D-Dimer in µg/L	Day 10
Biochemical profile by blood dosage of D-Dimer	D-Dimer in µg/L	Day 21
Biochemical profile by blood dosage of D-Dimer	D-Dimer in µg/L	Day 90
Biochemical profile by blood dosage of Troponin	Troponin in µg/L	Day 0
Biochemical profile by blood dosage of Troponin	Troponin in µg/L	Day 10
Biochemical profile by blood dosage of Troponin	Troponin in µg/L	Day 21
Biochemical profile by blood dosage of Troponin	Troponin in µg/L	Day 90
Biochemical profile by blood dosage of Ferritin	Ferritin in µg/L	Day 0
Biochemical profile by blood dosage of Ferritin	Ferritin in µg/L	Day 10
Biochemical profile by blood dosage of Ferritin	Ferritin in µg/L	Day 21
Biochemical profile by blood dosage of RAGE	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	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	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	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	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	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	leukocytes in Giga/L	Day 0
Haematological profile by blood dosage of leukocytes	leukocytes in Giga/L	Day 10
Haematological profile by blood dosage of leukocytes	leukocytes in Giga/L	Day 21
Haematological profile by blood dosage of leukocytes	leukocytes in Giga/L	Day 90
Haematological profile by blood dosage of Red blood cells	Red blood cells in Tera/L	Day 0
Haematological profile by blood dosage of Red blood cells	Red blood cells in Tera/L	Day 10
Haematological profile by blood dosage of Red blood cells	Red blood cells in Tera/L	Day 21
Haematological profile by blood dosage of Red blood cells	Red blood cells in Tera/L	Day 90
Haematological profile by blood dosage of Hemoglobin	Hemoglobin in g/dL	Day 0
Haematological profile by blood dosage of Hemoglobin	Hemoglobin in g/dL	Day 10
Haematological profile by blood dosage of Hemoglobin	Hemoglobin in g/dL	Day 21
Haematological profile by blood dosage of Hemoglobin	Hemoglobin in g/dL	Day 90
Haematological profile by blood dosage of Hematocrit	Hematocrit in %	Day 0
Haematological profile by blood dosage of Hematocrit	Hematocrit in %	Day 10
Haematological profile by blood dosage of Hematocrit	Hematocrit in %	Day 21
Haematological profile by blood dosage of Hematocrit	Hematocrit in %	Day 90
Haematological profile by blood dosage of Mean corpuscular volume	Mean corpuscular volume in fL	Day 0
Haematological profile by blood dosage of Mean corpuscular volume	Mean corpuscular volume in fL	Day 10
Haematological profile by blood dosage of Mean corpuscular volume	Mean corpuscular volume in fL	Day 21
Haematological profile by blood dosage of Mean corpuscular volume	Mean corpuscular volume in fL	Day 90
Haematological profile by blood dosage of Mean corpuscular hemoglobin	Mean corpuscular hemoglobin in pg	Day 0
Haematological profile by blood dosage of Mean corpuscular hemoglobin	Mean corpuscular hemoglobin in pg	Day 10
Haematological profile by blood dosage of Mean corpuscular hemoglobin	Mean corpuscular hemoglobin in pg	Day 21
Haematological profile by blood dosage of Mean corpuscular hemoglobin	Mean corpuscular hemoglobin in pg	Day 90
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin	Average corpuscular concentration of haemoglobin in g/dL	Day 0
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin	Average corpuscular concentration of haemoglobin in g/dL	Day 10
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin	Average corpuscular concentration of haemoglobin in g/dL	Day 21
Haematological profile by blood dosage of average corpuscular concentration of haemoglobin	Average corpuscular concentration of haemoglobin in g/dL	Day 90
Haematological profile by blood dosage of polynuclear neutrophil	polynuclear neutrophil in Giga/L	Day 0
Haematological profile by blood dosage of polynuclear neutrophil	polynuclear neutrophil in Giga/L	Day 10
Haematological profile by blood dosage of polynuclear neutrophil	polynuclear neutrophil in Giga/L	Day 21
Haematological profile by blood dosage of polynuclear neutrophil	polynuclear neutrophil in Giga/L	Day 90
Haematological profile by blood dosage of polynuclear eosinophils	polynuclear eosinophils in Giga/L	Day 0
Haematological profile by blood dosage of polynuclear eosinophils	polynuclear eosinophils in Giga/L	Day 10
Haematological profile by blood dosage of polynuclear eosinophils	polynuclear eosinophils in Giga/L	Day 21
Haematological profile by blood dosage of polynuclear eosinophils	polynuclear eosinophils in Giga/L	Day 90
Haematological profile by blood dosage of polynuclear basophils	polynuclear basophils in Giga/L	Day 0
Haematological profile by blood dosage of polynuclear basophils	polynuclear basophils in Giga/L	Day 10
Haematological profile by blood dosage of polynuclear basophils	polynuclear basophils in Giga/L	Day 21
Haematological profile by blood dosage of polynuclear basophils	polynuclear basophils in Giga/L	Day 90
Haematological profile by blood dosage of lymphocytes	lymphocytes in Giga/L	Day 0
Haematological profile by blood dosage of lymphocytes	lymphocytes in Giga/L	Day 10
Haematological profile by blood dosage of lymphocytes	lymphocytes in Giga/L	Day 21
Haematological profile by blood dosage of lymphocytes	lymphocytes in Giga/L	Day 90
Haematological profile by blood dosage of monocytes	monocytes in Giga/L	Day 90
Haematological profile by blood dosage of monocytes	monocytes in Giga/L	Day 0
Haematological profile by blood dosage of monocytes	monocytes in Giga/L	Day 10
Haematological profile by blood dosage of monocytes	monocytes in Giga/L	Day 21
Haematological profile by blood dosage of platelets	platelets in Giga/L	Day 0
Haematological profile by blood dosage of platelets	platelets in Giga/L	Day 10
Haematological profile by blood dosage of platelets	platelets in Giga/L	Day 21
Haematological profile by blood dosage of platelets	platelets in Giga/L	Day 90
Haematological profile by blood dosage of activated partial thromboplastin time	activated partial thromboplastin time in second/witness	Day 0
Haematological profile by blood dosage of activated partial thromboplastin time	activated partial thromboplastin time in second/witness	Day 10
Haematological profile by blood dosage of activated partial thromboplastin time	activated partial thromboplastin time in second/witness	Day 21
Haematological profile by blood dosage of activated partial thromboplastin time	activated partial thromboplastin time in second/witness	Day 90
Haematological profile by blood dosage of fibrinogen	fibrinogen in g/L	Day 0
Haematological profile by blood dosage of fibrinogen	fibrinogen in g/L	Day 10
Haematological profile by blood dosage of fibrinogen	fibrinogen in g/L	Day 21
Haematological profile by blood dosage of fibrinogen	fibrinogen in g/L	Day 90
Haematological profile by blood dosage of factor V	factor V in %	Day 0
Haematological profile by blood dosage of factor V	factor V in %	Day 10
Haematological profile by blood dosage of factor V	factor V in %	Day 21
Haematological profile by blood dosage of factor V	factor V in %	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 salivary viral load	RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL	Day 0
SARS-CoV-2 salivary viral load	RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL	Day 10
SARS-CoV-2 salivary viral load	RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL	Day 21
Comparison of viral sequences	bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)	Day 0
Comparison of viral sequences	bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)	Day 10
Comparison of viral sequences	bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)	Day 21
microbiota analysis	bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)	Day 0
microbiota analysis	bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)	Day 10
microbiota analysis	bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)	Day 21
environmental and societal factors (EPICE)	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	eating habits	Day 0
environmental and societal factors	eating habits	day 10
environmental and societal factors	eating habits	day 21
environmental and societal factors	eating habits	day 90
environmental and societal factors (SF-36)	SF-36 score (quality of life by Gardenal O) from 0 to 100	Day 0
environmental and societal factors (SF-36)	SF-36 score (quality of life by Gardenal O) from 0 to 100	day 10
environmental and societal factors (SF-36)	SF-36 score (quality of life by Gardenal O) from 0 to 100	day 21
environmental and societal factors (SF-36)	SF-36 score (quality of life by Gardenal O) from 0 to 100	day 90
environmental and societal factors (Physical activity)	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)	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)	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)	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	body weight in kg	Day 0
body weight	body weight in kg	day 10
body weight	body weight in kg	day 21
body weight	body weight in kg	day 90
oxygen saturation	oxygen saturation in %	Day 0
oxygen saturation	oxygen saturation in %	day 10
oxygen saturation	oxygen saturation in %	day 21
oxygen saturation	oxygen saturation in %	day 90
Respiratory rate	Respiratory rate per minute	Day 0
Respiratory rate	Respiratory rate per minute	day 10
Respiratory rate	Respiratory rate per minute	day 21
Respiratory rate	Respiratory rate per minute	day 90
cardiac frequency	cardiac frequency per minute	Day 0
cardiac frequency	cardiac frequency per minute	day 10
cardiac frequency	cardiac frequency per minute	day 21
cardiac frequency	cardiac frequency per minute	day 90
lung damage	Lung damage on auscultation in terms of presence/absence	Day 0
lung damage	Lung damage on auscultation in terms of presence/absence	day 10
lung damage	Lung damage on auscultation in terms of presence/absence	day 21
lung damage	Lung damage on auscultation in terms of presence/absence	day 90
lung evolution	CT san in terms of normal/abnormal (children and pregnant women not concerned)	day 90
blood pressure	Dysatolic/systolic blood pressure in mmHg	Day 0
blood pressure	Dysatolic/systolic blood pressure in mmHg	day 10
blood pressure	Dysatolic/systolic blood pressure in mmHg	day 21
blood pressure	Dysatolic/systolic blood pressure in mmHg	day 90
body temperature	Body temperature in °C	Day 0
body temperature	Body temperature in °C	day 10
body temperature	Body temperature in °C	day 21
body temperature	Body temperature in °C	day 90
clinical exam (skin)	Skin mottling in terms of presence/absence	Day 0
clinical exam (skin)	Skin mottling in terms of presence/absence	day 10
clinical exam (skin)	Skin mottling in terms of presence/absence	day 21
clinical exam (skin)	Skin mottling in terms of presence/absence	day 90
clinical exam (polypnea)	polypnea in terms of presence/absence	Day 0
clinical exam (polypnea)	polypnea in terms of presence/absence	day 10
clinical exam (polypnea)	polypnea in terms of presence/absence	day 21
clinical exam (polypnea)	polypnea in terms of presence/absence	day 90
denutrition	denutrition in terms of presence/absence	Day 0
denutrition	denutrition in terms of presence/absence	day 10
denutrition	denutrition in terms of presence/absence	day 21
denutrition	denutrition in terms of presence/absence	day 90
Antibiotic treatment	Antibiotic treatment in terms of presence/absence with precision if necessary	Day 0
Antibiotic treatment	Antibiotic treatment in terms of presence/absence with precision if necessary	day 10
Antibiotic treatment	Antibiotic treatment in terms of presence/absence with precision if necessary	day 21
Antibiotic treatment	Antibiotic treatment in terms of presence/absence with precision if necessary	day 90
Steroidal anti-inflammatory treatment	Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary	Day 0
Steroidal anti-inflammatory treatment	Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary	day 10
Steroidal anti-inflammatory treatment	Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary	day 21
Steroidal anti-inflammatory treatment	Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary	day 90
Anti-diabetic treatment	Anti-diabetic treatment in terms of presence/absence with precision if necessary	Day 0
Anti-diabetic treatment	Anti-diabetic treatment in terms of presence/absence with precision if necessary	day 10
Anti-diabetic treatment	Anti-diabetic treatment in terms of presence/absence with precision if necessary	day 21
Anti-diabetic treatment	Anti-diabetic treatment in terms of presence/absence with precision if necessary	day 90
Gastric protector treatment	Gastric protector treatment in terms of presence/absence with precision if necessary	Day 0
Gastric protector treatment	Gastric protector treatment in terms of presence/absence with precision if necessary	day 10
Gastric protector treatment	Gastric protector treatment in terms of presence/absence with precision if necessary	day 21
Gastric protector treatment	Gastric protector treatment in terms of presence/absence with precision if necessary	day 90
chills	chills in terms of presence/absence	Day 0
chills	chills in terms of presence/absence	day 10
chills	chills in terms of presence/absence	day 21
chills	chills in terms of presence/absence	day 90
Myalgia	Myalgia in terms of presence/absence	Day 0
Myalgia	Myalgia in terms of presence/absence	day 10
Myalgia	Myalgia in terms of presence/absence	day 21
Myalgia	Myalgia in terms of presence/absence	day 90
Anorexia	Anorexia in terms of presence/absence	Day 0
Anorexia	Anorexia in terms of presence/absence	day 10
Anorexia	Anorexia in terms of presence/absence	day 21
Anorexia	Anorexia in terms of presence/absence	day 90
Rhinitis	Rhinitis in terms of presence/absence	Day 0
Rhinitis	Rhinitis in terms of presence/absence	day 10
Rhinitis	Rhinitis in terms of presence/absence	day 21
Rhinitis	Rhinitis in terms of presence/absence	day 90
Confusion	Confusion in terms of presence/absence	Day 0
Confusion	Confusion in terms of presence/absence	day 10
Confusion	Confusion in terms of presence/absence	day 21
Confusion	Confusion in terms of presence/absence	day 90
Asthenia	Asthenia in terms of presence/absence	Day 0
Asthenia	Asthenia in terms of presence/absence	day 10
Asthenia	Asthenia in terms of presence/absence	day 21
Asthenia	Asthenia in terms of presence/absence	day 90
Falls at home	Falls at home in terms of presence/absence	Day 0
Falls at home	Falls at home in terms of presence/absence	day 10
Falls at home	Falls at home in terms of presence/absence	day 21
Falls at home	Falls at home in terms of presence/absence	day 90
Insomnia	Insomnia in terms of presence/absence	Day 0
Insomnia	Insomnia in terms of presence/absence	day 10
Insomnia	Insomnia in terms of presence/absence	day 21
Insomnia	Insomnia in terms of presence/absence	day 90
Angina	Angina in terms of presence/absence	Day 0
Angina	Angina in terms of presence/absence	day 10
Angina	Angina in terms of presence/absence	day 21
Angina	Angina in terms of presence/absence	day 90
Ageusia	Ageusia in terms of presence/absence	Day 0
Ageusia	Ageusia in terms of presence/absence	day 10
Ageusia	Ageusia in terms of presence/absence	day 21
Ageusia	Ageusia in terms of presence/absence	day 90
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	Day 0
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 2
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 4
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 6
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 8
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 10
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 21
Respiratory complaints	Respiratory complaints in term of SRIpr score from 0 to 100	day 90
transmission rate	Rate of viral transmission determine by bioinformatic and statistical analyzes in %	Day 0
transmission rate	Rate of viral transmission determine by bioinformatic and statistical analyzes in %	day 10
transmission rate	Rate of viral transmission determine by bioinformatic and statistical analyzes in %	day 21
prolonged viral shedding	Prolonged viral shedding evaluate by RT-PCR (CT value or log10 copies per mL)	between day 0 and day 21

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Céclie Henquell, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID19; cluster; Biological collection; Confirmed case; contact case
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RBPH 2020 HENQUELL; 2020-A02381-38 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No