Clinical trial NCT04597736: Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Contact Case
Keywords: SARS-CoV-2
COVID19
Confirmed case
Biological collection
contact case
cluster
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Virological profile
timeFrame: Day 0
measure: Virological profile
timeFrame: Day 10
measure: Virological profile
timeFrame: Day 21
measure: Virological profile (serology)
timeFrame: Day 0
measure: Virological profile (serology)
timeFrame: Day 10
measure: Virological profile (serology)
timeFrame: Day 21
measure: Immunological profile with blood level for markers of inflammation (cytokine)
timeFrame: Day 0
measure: Immunological profile with blood level for markers of inflammation (cytokine)
timeFrame: Day 10
measure: Immunological profile with blood level for markers of inflammation (cytokine)
timeFrame: Day 21
measure: Immunological profile with blood level for markers of inflammation
timeFrame: Day 0
measure: Immunological profile with blood level for markers of inflammation
timeFrame: Day 10
measure: Immunological profile with blood level for markers of inflammation
timeFrame: Day 21
measure: Biochemical profile by blood dosage of CRP
timeFrame: Day 0
measure: Biochemical profile by blood dosage of CRP
timeFrame: Day 10
measure: Biochemical profile by blood dosage of CRP
timeFrame: Day 21
measure: Biochemical profile by blood dosage of CRP
timeFrame: Day 90
measure: Biochemical profile by blood dosage of ASAT/ALAT
timeFrame: Day 0
measure: Biochemical profile by blood dosage of ASAT/ALAT
timeFrame: Day 10
measure: Biochemical profile by blood dosage of ASAT/ALAT
timeFrame: Day 21
measure: Biochemical profile by blood dosage of ASAT/ALAT
timeFrame: Day 90
measure: Biochemical profile by blood dosage of LDH
timeFrame: Day 0
measure: Biochemical profile by blood dosage of LDH
timeFrame: Day 10
measure: Biochemical profile by blood dosage of LDH
timeFrame: Day 21
measure: Biochemical profile by blood dosage of LDH
timeFrame: Day 90
measure: Biochemical profile by blood dosage of Lactate
timeFrame: Day 0
measure: Biochemical profile by blood dosage of Lactate
timeFrame: Day 10
measure: Biochemical profile by blood dosage of Lactate
timeFrame: Day 21
measure: Biochemical profile by blood dosage of Lactate
timeFrame: Day 90
measure: Biochemical profile by blood dosage of D-Dimer
timeFrame: Day 0
measure: Biochemical profile by blood dosage of D-Dimer
timeFrame: Day 10
measure: Biochemical profile by blood dosage of D-Dimer
timeFrame: Day 21
measure: Biochemical profile by blood dosage of D-Dimer
timeFrame: Day 90
measure: Biochemical profile by blood dosage of Troponin
timeFrame: Day 0
measure: Biochemical profile by blood dosage of Troponin
timeFrame: Day 10
measure: Biochemical profile by blood dosage of Troponin
timeFrame: Day 21
measure: Biochemical profile by blood dosage of Troponin
timeFrame: Day 90
measure: Biochemical profile by blood dosage of Ferritin
timeFrame: Day 0
measure: Biochemical profile by blood dosage of Ferritin
timeFrame: Day 10
measure: Biochemical profile by blood dosage of Ferritin
timeFrame: Day 21
measure: Biochemical profile by blood dosage of RAGE
timeFrame: Day 0
measure: Biochemical profile by blood dosage of RAGE
timeFrame: Day 10
measure: Biochemical profile by blood dosage of RAGE
timeFrame: Day 21
measure: Biochemical profile by blood dosage of SUPAR
timeFrame: Day 0
measure: Biochemical profile by blood dosage of SUPAR
timeFrame: Day 10
measure: Biochemical profile by blood dosage of SUPAR
timeFrame: Day 21
measure: Haematological profile by blood dosage of leukocytes
timeFrame: Day 0
measure: Haematological profile by blood dosage of leukocytes
timeFrame: Day 10
measure: Haematological profile by blood dosage of leukocytes
timeFrame: Day 21
measure: Haematological profile by blood dosage of leukocytes
timeFrame: Day 90
measure: Haematological profile by blood dosage of Red blood cells
timeFrame: Day 0
measure: Haematological profile by blood dosage of Red blood cells
timeFrame: Day 10
measure: Haematological profile by blood dosage of Red blood cells
timeFrame: Day 21
measure: Haematological profile by blood dosage of Red blood cells
timeFrame: Day 90
measure: Haematological profile by blood dosage of Hemoglobin
timeFrame: Day 0
measure: Haematological profile by blood dosage of Hemoglobin
timeFrame: Day 10
measure: Haematological profile by blood dosage of Hemoglobin
timeFrame: Day 21
measure: Haematological profile by blood dosage of Hemoglobin
timeFrame: Day 90
measure: Haematological profile by blood dosage of Hematocrit
timeFrame: Day 0
measure: Haematological profile by blood dosage of Hematocrit
timeFrame: Day 10
measure: Haematological profile by blood dosage of Hematocrit
timeFrame: Day 21
measure: Haematological profile by blood dosage of Hematocrit
timeFrame: Day 90
measure: Haematological profile by blood dosage of Mean corpuscular volume
timeFrame: Day 0
measure: Haematological profile by blood dosage of Mean corpuscular volume
timeFrame: Day 10
measure: Haematological profile by blood dosage of Mean corpuscular volume
timeFrame: Day 21
measure: Haematological profile by blood dosage of Mean corpuscular volume
timeFrame: Day 90
measure: Haematological profile by blood dosage of Mean corpuscular hemoglobin
timeFrame: Day 0
measure: Haematological profile by blood dosage of Mean corpuscular hemoglobin
timeFrame: Day 10
measure: Haematological profile by blood dosage of Mean corpuscular hemoglobin
timeFrame: Day 21
measure: Haematological profile by blood dosage of Mean corpuscular hemoglobin
timeFrame: Day 90
measure: Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
timeFrame: Day 0
measure: Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
timeFrame: Day 10
measure: Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
timeFrame: Day 21
measure: Haematological profile by blood dosage of average corpuscular concentration of haemoglobin
timeFrame: Day 90
measure: Haematological profile by blood dosage of polynuclear neutrophil
timeFrame: Day 0
measure: Haematological profile by blood dosage of polynuclear neutrophil
timeFrame: Day 10
measure: Haematological profile by blood dosage of polynuclear neutrophil
timeFrame: Day 21
measure: Haematological profile by blood dosage of polynuclear neutrophil
timeFrame: Day 90
measure: Haematological profile by blood dosage of polynuclear eosinophils
timeFrame: Day 0
measure: Haematological profile by blood dosage of polynuclear eosinophils
timeFrame: Day 10
measure: Haematological profile by blood dosage of polynuclear eosinophils
timeFrame: Day 21
measure: Haematological profile by blood dosage of polynuclear eosinophils
timeFrame: Day 90
measure: Haematological profile by blood dosage of polynuclear basophils
timeFrame: Day 0
measure: Haematological profile by blood dosage of polynuclear basophils
timeFrame: Day 10
measure: Haematological profile by blood dosage of polynuclear basophils
timeFrame: Day 21
measure: Haematological profile by blood dosage of polynuclear basophils
timeFrame: Day 90
measure: Haematological profile by blood dosage of lymphocytes
timeFrame: Day 0
measure: Haematological profile by blood dosage of lymphocytes
timeFrame: Day 10
measure: Haematological profile by blood dosage of lymphocytes
timeFrame: Day 21
measure: Haematological profile by blood dosage of lymphocytes
timeFrame: Day 90
measure: Haematological profile by blood dosage of monocytes
timeFrame: Day 90
measure: Haematological profile by blood dosage of monocytes
timeFrame: Day 0
measure: Haematological profile by blood dosage of monocytes
timeFrame: Day 10
measure: Haematological profile by blood dosage of monocytes
timeFrame: Day 21
measure: Haematological profile by blood dosage of platelets
timeFrame: Day 0
measure: Haematological profile by blood dosage of platelets
timeFrame: Day 10
measure: Haematological profile by blood dosage of platelets
timeFrame: Day 21
measure: Haematological profile by blood dosage of platelets
timeFrame: Day 90
measure: Haematological profile by blood dosage of activated partial thromboplastin time
timeFrame: Day 0
measure: Haematological profile by blood dosage of activated partial thromboplastin time
timeFrame: Day 10
measure: Haematological profile by blood dosage of activated partial thromboplastin time
timeFrame: Day 21
measure: Haematological profile by blood dosage of activated partial thromboplastin time
timeFrame: Day 90
measure: Haematological profile by blood dosage of fibrinogen
timeFrame: Day 0
measure: Haematological profile by blood dosage of fibrinogen
timeFrame: Day 10
measure: Haematological profile by blood dosage of fibrinogen
timeFrame: Day 21
measure: Haematological profile by blood dosage of fibrinogen
timeFrame: Day 90
measure: Haematological profile by blood dosage of factor V
timeFrame: Day 0
measure: Haematological profile by blood dosage of factor V
timeFrame: Day 10
measure: Haematological profile by blood dosage of factor V
timeFrame: Day 21
measure: Haematological profile by blood dosage of factor V
timeFrame: Day 90
Secondary outcomes:
measure: SARS-CoV-2 salivary viral load
timeFrame: Day 0
measure: SARS-CoV-2 salivary viral load
timeFrame: Day 10
measure: SARS-CoV-2 salivary viral load
timeFrame: Day 21
measure: Comparison of viral sequences
timeFrame: Day 0
measure: Comparison of viral sequences
timeFrame: Day 10
measure: Comparison of viral sequences
timeFrame: Day 21
measure: microbiota analysis
timeFrame: Day 0
measure: microbiota analysis
timeFrame: Day 10
measure: microbiota analysis
timeFrame: Day 21
measure: environmental and societal factors (EPICE)
timeFrame: Day 0
measure: environmental and societal factors
timeFrame: Day 0
measure: environmental and societal factors
timeFrame: day 10
measure: environmental and societal factors
timeFrame: day 21
measure: environmental and societal factors
timeFrame: day 90
measure: environmental and societal factors (SF-36)
timeFrame: Day 0
measure: environmental and societal factors (SF-36)
timeFrame: day 10
measure: environmental and societal factors (SF-36)
timeFrame: day 21
measure: environmental and societal factors (SF-36)
timeFrame: day 90
measure: environmental and societal factors (Physical activity)
timeFrame: Day 0
measure: environmental and societal factors (Physical activity)
timeFrame: day 10
measure: environmental and societal factors (Physical activity)
timeFrame: day 21
measure: environmental and societal factors (Physical activity)
timeFrame: day 90
measure: body weight
timeFrame: Day 0
measure: body weight
timeFrame: day 10
measure: body weight
timeFrame: day 21
measure: body weight
timeFrame: day 90
measure: oxygen saturation
timeFrame: Day 0
measure: oxygen saturation
timeFrame: day 10
measure: oxygen saturation
timeFrame: day 21
measure: oxygen saturation
timeFrame: day 90
measure: Respiratory rate
timeFrame: Day 0
measure: Respiratory rate
timeFrame: day 10
measure: Respiratory rate
timeFrame: day 21
measure: Respiratory rate
timeFrame: day 90
measure: cardiac frequency
timeFrame: Day 0
measure: cardiac frequency
timeFrame: day 10
measure: cardiac frequency
timeFrame: day 21
measure: cardiac frequency
timeFrame: day 90
measure: lung damage
timeFrame: Day 0
measure: lung damage
timeFrame: day 10
measure: lung damage
timeFrame: day 21
measure: lung damage
timeFrame: day 90
measure: lung evolution
timeFrame: day 90
measure: blood pressure
timeFrame: Day 0
measure: blood pressure
timeFrame: day 10
measure: blood pressure
timeFrame: day 21
measure: blood pressure
timeFrame: day 90
measure: body temperature
timeFrame: Day 0
measure: body temperature
timeFrame: day 10
measure: body temperature
timeFrame: day 21
measure: body temperature
timeFrame: day 90
measure: clinical exam (skin)
timeFrame: Day 0
measure: clinical exam (skin)
timeFrame: day 10
measure: clinical exam (skin)
timeFrame: day 21
measure: clinical exam (skin)
timeFrame: day 90
measure: clinical exam (polypnea)
timeFrame: Day 0
measure: clinical exam (polypnea)
timeFrame: day 10
measure: clinical exam (polypnea)
timeFrame: day 21
measure: clinical exam (polypnea)
timeFrame: day 90
measure: denutrition
timeFrame: Day 0
measure: denutrition
timeFrame: day 10
measure: denutrition
timeFrame: day 21
measure: denutrition
timeFrame: day 90
measure: Antibiotic treatment
timeFrame: Day 0
measure: Antibiotic treatment
timeFrame: day 10
measure: Antibiotic treatment
timeFrame: day 21
measure: Antibiotic treatment
timeFrame: day 90
measure: Steroidal anti-inflammatory treatment
timeFrame: Day 0
measure: Steroidal anti-inflammatory treatment
timeFrame: day 10
measure: Steroidal anti-inflammatory treatment
timeFrame: day 21
measure: Steroidal anti-inflammatory treatment
timeFrame: day 90
measure: Anti-diabetic treatment
timeFrame: Day 0
measure: Anti-diabetic treatment
timeFrame: day 10
measure: Anti-diabetic treatment
timeFrame: day 21
measure: Anti-diabetic treatment
timeFrame: day 90
measure: Gastric protector treatment
timeFrame: Day 0
measure: Gastric protector treatment
timeFrame: day 10
measure: Gastric protector treatment
timeFrame: day 21
measure: Gastric protector treatment
timeFrame: day 90
measure: chills
timeFrame: Day 0
measure: chills
timeFrame: day 10
measure: chills
timeFrame: day 21
measure: chills
timeFrame: day 90
measure: Myalgia
timeFrame: Day 0
measure: Myalgia
timeFrame: day 10
measure: Myalgia
timeFrame: day 21
measure: Myalgia
timeFrame: day 90
measure: Anorexia
timeFrame: Day 0
measure: Anorexia
timeFrame: day 10
measure: Anorexia
timeFrame: day 21
measure: Anorexia
timeFrame: day 90
measure: Rhinitis
timeFrame: Day 0
measure: Rhinitis
timeFrame: day 10
measure: Rhinitis
timeFrame: day 21
measure: Rhinitis
timeFrame: day 90
measure: Confusion
timeFrame: Day 0
measure: Confusion
timeFrame: day 10
measure: Confusion
timeFrame: day 21
measure: Confusion
timeFrame: day 90
measure: Asthenia
timeFrame: Day 0
measure: Asthenia
timeFrame: day 10
measure: Asthenia
timeFrame: day 21
measure: Asthenia
timeFrame: day 90
measure: Falls at home
timeFrame: Day 0
measure: Falls at home
timeFrame: day 10
measure: Falls at home
timeFrame: day 21
measure: Falls at home
timeFrame: day 90
measure: Insomnia
timeFrame: Day 0
measure: Insomnia
timeFrame: day 10
measure: Insomnia
timeFrame: day 21
measure: Insomnia
timeFrame: day 90
measure: Angina
timeFrame: Day 0
measure: Angina
timeFrame: day 10
measure: Angina
timeFrame: day 21
measure: Angina
timeFrame: day 90
measure: Ageusia
timeFrame: Day 0
measure: Ageusia
timeFrame: day 10
measure: Ageusia
timeFrame: day 21
measure: Ageusia
timeFrame: day 90
measure: Respiratory complaints
timeFrame: Day 0
measure: Respiratory complaints
timeFrame: day 2
measure: Respiratory complaints
timeFrame: day 4
measure: Respiratory complaints
timeFrame: day 6
measure: Respiratory complaints
timeFrame: day 8
measure: Respiratory complaints
timeFrame: day 10
measure: Respiratory complaints
timeFrame: day 21
measure: Respiratory complaints
timeFrame: day 90
measure: transmission rate
timeFrame: Day 0
measure: transmission rate
timeFrame: day 10
measure: transmission rate
timeFrame: day 21
measure: prolonged viral shedding
timeFrame: between day 0 and day 21
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Céclie Henquell
role: PRINCIPAL_INVESTIGATOR
References: