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

NCT04597736 | Unknown

• 2 other identifiers: RBPH 2020 HENQUELL2020-A02381-38
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19; Contact Case

Keywords

SARS-CoV-2; COVID19; Confirmed case; Biological collection; contact case; cluster

Outcome Measures

Primary Outcomes (109)

• 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 Outcomes (131)

• SARS-CoV-2 salivary viral load

  Day 0

• SARS-CoV-2 salivary viral load

  Day 10

• SARS-CoV-2 salivary viral load

  Day 21

• Comparison of viral sequences

  Day 0

• Comparison of viral sequences

  Day 10

Study Arms (1)

cohort

EXPERIMENTAL

Biological collection with nasopharyngeal samples, saliva, blood, stool and urine

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

Interventions

Biological collection with nasopharyngeal samples, saliva, blood, stool and urine BIOLOGICAL

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.

cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
• Refusal of the child
• Refusal of participation

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection; Defecation; Urination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Céclie Henquell

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-09

Locations

FR (1)