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

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ClinicalTrials.gov Identifier: NCT04597736
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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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).


Condition or disease Intervention/treatment Phase
Covid19 Contact Case Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine Not Applicable

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 Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Virological profile [ Time Frame: Day 0 ]
    Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)

  2. Virological profile [ Time Frame: Day 10 ]
    Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)

  3. Virological profile [ Time Frame: Day 21 ]
    Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)

  4. Virological profile (serology) [ Time Frame: Day 0 ]
    SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)

  5. Virological profile (serology) [ Time Frame: Day 10 ]
    SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)

  6. Virological profile (serology) [ Time Frame: Day 21 ]
    SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)

  7. Immunological profile with blood level for markers of inflammation (cytokine) [ Time Frame: Day 0 ]
    cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL

  8. Immunological profile with blood level for markers of inflammation (cytokine) [ Time Frame: Day 10 ]
    cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL

  9. Immunological profile with blood level for markers of inflammation (cytokine) [ Time Frame: Day 21 ]
    cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL

  10. Immunological profile with blood level for markers of inflammation [ Time Frame: Day 0 ]
    markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %

  11. Immunological profile with blood level for markers of inflammation [ Time Frame: Day 10 ]
    markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %

  12. Immunological profile with blood level for markers of inflammation [ Time Frame: Day 21 ]
    markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %

  13. Biochemical profile by blood dosage of CRP [ Time Frame: Day 0 ]
    CRP in mg/l

  14. Biochemical profile by blood dosage of CRP [ Time Frame: Day 10 ]
    CRP in mg/l

  15. Biochemical profile by blood dosage of CRP [ Time Frame: Day 21 ]
    CRP in mg/l

  16. Biochemical profile by blood dosage of CRP [ Time Frame: Day 90 ]
    CRP in mg/l

  17. Biochemical profile by blood dosage of ASAT/ALAT [ Time Frame: Day 0 ]
    ASAT/ALAT in U/L

  18. Biochemical profile by blood dosage of ASAT/ALAT [ Time Frame: Day 10 ]
    ASAT/ALAT in U/L

  19. Biochemical profile by blood dosage of ASAT/ALAT [ Time Frame: Day 21 ]
    ASAT/ALAT in U/L

  20. Biochemical profile by blood dosage of ASAT/ALAT [ Time Frame: Day 90 ]
    ASAT/ALAT in U/L

  21. Biochemical profile by blood dosage of LDH [ Time Frame: Day 0 ]
    LDH in U/L

  22. Biochemical profile by blood dosage of LDH [ Time Frame: Day 10 ]
    LDH in U/L

  23. Biochemical profile by blood dosage of LDH [ Time Frame: Day 21 ]
    LDH in U/L

  24. Biochemical profile by blood dosage of LDH [ Time Frame: Day 90 ]
    LDH in U/L

  25. Biochemical profile by blood dosage of Lactate [ Time Frame: Day 0 ]
    Lactate in mg/l

  26. Biochemical profile by blood dosage of Lactate [ Time Frame: Day 10 ]
    Lactate in mg/l

  27. Biochemical profile by blood dosage of Lactate [ Time Frame: Day 21 ]
    Lactate in mg/l

  28. Biochemical profile by blood dosage of Lactate [ Time Frame: Day 90 ]
    Lactate in mg/l

  29. Biochemical profile by blood dosage of D-Dimer [ Time Frame: Day 0 ]
    D-Dimer in µg/L

  30. Biochemical profile by blood dosage of D-Dimer [ Time Frame: Day 10 ]
    D-Dimer in µg/L

  31. Biochemical profile by blood dosage of D-Dimer [ Time Frame: Day 21 ]
    D-Dimer in µg/L

  32. Biochemical profile by blood dosage of D-Dimer [ Time Frame: Day 90 ]
    D-Dimer in µg/L

  33. Biochemical profile by blood dosage of Troponin [ Time Frame: Day 0 ]
    Troponin in µg/L

  34. Biochemical profile by blood dosage of Troponin [ Time Frame: Day 10 ]
    Troponin in µg/L

  35. Biochemical profile by blood dosage of Troponin [ Time Frame: Day 21 ]
    Troponin in µg/L

  36. Biochemical profile by blood dosage of Troponin [ Time Frame: Day 90 ]
    Troponin in µg/L

  37. Biochemical profile by blood dosage of Ferritin [ Time Frame: Day 0 ]
    Ferritin in µg/L

  38. Biochemical profile by blood dosage of Ferritin [ Time Frame: Day 10 ]
    Ferritin in µg/L

  39. Biochemical profile by blood dosage of Ferritin [ Time Frame: Day 21 ]
    Ferritin in µg/L

  40. Biochemical profile by blood dosage of RAGE [ Time Frame: Day 0 ]
    RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein

  41. Biochemical profile by blood dosage of RAGE [ Time Frame: Day 10 ]
    RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein

  42. Biochemical profile by blood dosage of RAGE [ Time Frame: Day 21 ]
    RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein

  43. Biochemical profile by blood dosage of SUPAR [ Time Frame: Day 0 ]
    SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein

  44. Biochemical profile by blood dosage of SUPAR [ Time Frame: Day 10 ]
    SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein

  45. Biochemical profile by blood dosage of SUPAR [ Time Frame: Day 21 ]
    SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein

  46. Haematological profile by blood dosage of leukocytes [ Time Frame: Day 0 ]
    leukocytes in Giga/L

  47. Haematological profile by blood dosage of leukocytes [ Time Frame: Day 10 ]
    leukocytes in Giga/L

  48. Haematological profile by blood dosage of leukocytes [ Time Frame: Day 21 ]
    leukocytes in Giga/L

  49. Haematological profile by blood dosage of leukocytes [ Time Frame: Day 90 ]
    leukocytes in Giga/L

  50. Haematological profile by blood dosage of Red blood cells [ Time Frame: Day 0 ]
    Red blood cells in Tera/L

  51. Haematological profile by blood dosage of Red blood cells [ Time Frame: Day 10 ]
    Red blood cells in Tera/L

  52. Haematological profile by blood dosage of Red blood cells [ Time Frame: Day 21 ]
    Red blood cells in Tera/L

  53. Haematological profile by blood dosage of Red blood cells [ Time Frame: Day 90 ]
    Red blood cells in Tera/L

  54. Haematological profile by blood dosage of Hemoglobin [ Time Frame: Day 0 ]
    Hemoglobin in g/dL

  55. Haematological profile by blood dosage of Hemoglobin [ Time Frame: Day 10 ]
    Hemoglobin in g/dL

  56. Haematological profile by blood dosage of Hemoglobin [ Time Frame: Day 21 ]
    Hemoglobin in g/dL

  57. Haematological profile by blood dosage of Hemoglobin [ Time Frame: Day 90 ]
    Hemoglobin in g/dL

  58. Haematological profile by blood dosage of Hematocrit [ Time Frame: Day 0 ]
    Hematocrit in %

  59. Haematological profile by blood dosage of Hematocrit [ Time Frame: Day 10 ]
    Hematocrit in %

  60. Haematological profile by blood dosage of Hematocrit [ Time Frame: Day 21 ]
    Hematocrit in %

  61. Haematological profile by blood dosage of Hematocrit [ Time Frame: Day 90 ]
    Hematocrit in %

  62. Haematological profile by blood dosage of Mean corpuscular volume [ Time Frame: Day 0 ]
    Mean corpuscular volume in fL

  63. Haematological profile by blood dosage of Mean corpuscular volume [ Time Frame: Day 10 ]
    Mean corpuscular volume in fL

  64. Haematological profile by blood dosage of Mean corpuscular volume [ Time Frame: Day 21 ]
    Mean corpuscular volume in fL

  65. Haematological profile by blood dosage of Mean corpuscular volume [ Time Frame: Day 90 ]
    Mean corpuscular volume in fL

  66. Haematological profile by blood dosage of Mean corpuscular hemoglobin [ Time Frame: Day 0 ]
    Mean corpuscular hemoglobin in pg

  67. Haematological profile by blood dosage of Mean corpuscular hemoglobin [ Time Frame: Day 10 ]
    Mean corpuscular hemoglobin in pg

  68. Haematological profile by blood dosage of Mean corpuscular hemoglobin [ Time Frame: Day 21 ]
    Mean corpuscular hemoglobin in pg

  69. Haematological profile by blood dosage of Mean corpuscular hemoglobin [ Time Frame: Day 90 ]
    Mean corpuscular hemoglobin in pg

  70. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin [ Time Frame: Day 0 ]
    Average corpuscular concentration of haemoglobin in g/dL

  71. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin [ Time Frame: Day 10 ]
    Average corpuscular concentration of haemoglobin in g/dL

  72. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin [ Time Frame: Day 21 ]
    Average corpuscular concentration of haemoglobin in g/dL

  73. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin [ Time Frame: Day 90 ]
    Average corpuscular concentration of haemoglobin in g/dL

  74. Haematological profile by blood dosage of polynuclear neutrophil [ Time Frame: Day 0 ]
    polynuclear neutrophil in Giga/L

  75. Haematological profile by blood dosage of polynuclear neutrophil [ Time Frame: Day 10 ]
    polynuclear neutrophil in Giga/L

  76. Haematological profile by blood dosage of polynuclear neutrophil [ Time Frame: Day 21 ]
    polynuclear neutrophil in Giga/L

  77. Haematological profile by blood dosage of polynuclear neutrophil [ Time Frame: Day 90 ]
    polynuclear neutrophil in Giga/L

  78. Haematological profile by blood dosage of polynuclear eosinophils [ Time Frame: Day 0 ]
    polynuclear eosinophils in Giga/L

  79. Haematological profile by blood dosage of polynuclear eosinophils [ Time Frame: Day 10 ]
    polynuclear eosinophils in Giga/L

  80. Haematological profile by blood dosage of polynuclear eosinophils [ Time Frame: Day 21 ]
    polynuclear eosinophils in Giga/L

  81. Haematological profile by blood dosage of polynuclear eosinophils [ Time Frame: Day 90 ]
    polynuclear eosinophils in Giga/L

  82. Haematological profile by blood dosage of polynuclear basophils [ Time Frame: Day 0 ]
    polynuclear basophils in Giga/L

  83. Haematological profile by blood dosage of polynuclear basophils [ Time Frame: Day 10 ]
    polynuclear basophils in Giga/L

  84. Haematological profile by blood dosage of polynuclear basophils [ Time Frame: Day 21 ]
    polynuclear basophils in Giga/L

  85. Haematological profile by blood dosage of polynuclear basophils [ Time Frame: Day 90 ]
    polynuclear basophils in Giga/L

  86. Haematological profile by blood dosage of lymphocytes [ Time Frame: Day 0 ]
    lymphocytes in Giga/L

  87. Haematological profile by blood dosage of lymphocytes [ Time Frame: Day 10 ]
    lymphocytes in Giga/L

  88. Haematological profile by blood dosage of lymphocytes [ Time Frame: Day 21 ]
    lymphocytes in Giga/L

  89. Haematological profile by blood dosage of lymphocytes [ Time Frame: Day 90 ]
    lymphocytes in Giga/L

  90. Haematological profile by blood dosage of monocytes [ Time Frame: Day 90 ]
    monocytes in Giga/L

  91. Haematological profile by blood dosage of monocytes [ Time Frame: Day 0 ]
    monocytes in Giga/L

  92. Haematological profile by blood dosage of monocytes [ Time Frame: Day 10 ]
    monocytes in Giga/L

  93. Haematological profile by blood dosage of monocytes [ Time Frame: Day 21 ]
    monocytes in Giga/L

  94. Haematological profile by blood dosage of platelets [ Time Frame: Day 0 ]
    platelets in Giga/L

  95. Haematological profile by blood dosage of platelets [ Time Frame: Day 10 ]
    platelets in Giga/L

  96. Haematological profile by blood dosage of platelets [ Time Frame: Day 21 ]
    platelets in Giga/L

  97. Haematological profile by blood dosage of platelets [ Time Frame: Day 90 ]
    platelets in Giga/L

  98. Haematological profile by blood dosage of activated partial thromboplastin time [ Time Frame: Day 0 ]
    activated partial thromboplastin time in second/witness

  99. Haematological profile by blood dosage of activated partial thromboplastin time [ Time Frame: Day 10 ]
    activated partial thromboplastin time in second/witness

  100. Haematological profile by blood dosage of activated partial thromboplastin time [ Time Frame: Day 21 ]
    activated partial thromboplastin time in second/witness

  101. Haematological profile by blood dosage of activated partial thromboplastin time [ Time Frame: Day 90 ]
    activated partial thromboplastin time in second/witness

  102. Haematological profile by blood dosage of fibrinogen [ Time Frame: Day 0 ]
    fibrinogen in g/L

  103. Haematological profile by blood dosage of fibrinogen [ Time Frame: Day 10 ]
    fibrinogen in g/L

  104. Haematological profile by blood dosage of fibrinogen [ Time Frame: Day 21 ]
    fibrinogen in g/L

  105. Haematological profile by blood dosage of fibrinogen [ Time Frame: Day 90 ]
    fibrinogen in g/L

  106. Haematological profile by blood dosage of factor V [ Time Frame: Day 0 ]
    factor V in %

  107. Haematological profile by blood dosage of factor V [ Time Frame: Day 10 ]
    factor V in %

  108. Haematological profile by blood dosage of factor V [ Time Frame: Day 21 ]
    factor V in %

  109. Haematological profile by blood dosage of factor V [ Time Frame: Day 90 ]
    factor V in %


Secondary Outcome Measures :
  1. SARS-CoV-2 salivary viral load [ Time Frame: Day 0 ]
    RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL

  2. SARS-CoV-2 salivary viral load [ Time Frame: Day 10 ]
    RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL

  3. SARS-CoV-2 salivary viral load [ Time Frame: Day 21 ]
    RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL

  4. Comparison of viral sequences [ Time Frame: Day 0 ]
    bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)

  5. Comparison of viral sequences [ Time Frame: Day 10 ]
    bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)

  6. Comparison of viral sequences [ Time Frame: Day 21 ]
    bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)

  7. microbiota analysis [ Time Frame: Day 0 ]
    bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)

  8. microbiota analysis [ Time Frame: Day 10 ]
    bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)

  9. microbiota analysis [ Time Frame: Day 21 ]
    bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)

  10. environmental and societal factors (EPICE) [ Time Frame: Day 0 ]
    EPICE score (Assessment of precariousness and health inequalities in examination centers Health) at day 0 from 0 to 100

  11. environmental and societal factors [ Time Frame: Day 0 ]
    eating habits

  12. environmental and societal factors [ Time Frame: day 10 ]
    eating habits

  13. environmental and societal factors [ Time Frame: day 21 ]
    eating habits

  14. environmental and societal factors [ Time Frame: day 90 ]
    eating habits

  15. environmental and societal factors (SF-36) [ Time Frame: Day 0 ]
    SF-36 score (quality of life by Gardenal O) from 0 to 100

  16. environmental and societal factors (SF-36) [ Time Frame: day 10 ]
    SF-36 score (quality of life by Gardenal O) from 0 to 100

  17. environmental and societal factors (SF-36) [ Time Frame: day 21 ]
    SF-36 score (quality of life by Gardenal O) from 0 to 100

  18. environmental and societal factors (SF-36) [ Time Frame: day 90 ]
    SF-36 score (quality of life by Gardenal O) from 0 to 100

  19. environmental and societal factors (Physical activity) [ Time Frame: Day 0 ]
    Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100

  20. environmental and societal factors (Physical activity) [ Time Frame: day 10 ]
    Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100

  21. environmental and societal factors (Physical activity) [ Time Frame: day 21 ]
    Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100

  22. environmental and societal factors (Physical activity) [ Time Frame: day 90 ]
    Physical activity score (by J. Ricci et L. Gagnon test for adults and ActiFitY test for children) from 0 to 100

  23. body weight [ Time Frame: Day 0 ]
    body weight in kg

  24. body weight [ Time Frame: day 10 ]
    body weight in kg

  25. body weight [ Time Frame: day 21 ]
    body weight in kg

  26. body weight [ Time Frame: day 90 ]
    body weight in kg

  27. oxygen saturation [ Time Frame: Day 0 ]
    oxygen saturation in %

  28. oxygen saturation [ Time Frame: day 10 ]
    oxygen saturation in %

  29. oxygen saturation [ Time Frame: day 21 ]
    oxygen saturation in %

  30. oxygen saturation [ Time Frame: day 90 ]
    oxygen saturation in %

  31. Respiratory rate [ Time Frame: Day 0 ]
    Respiratory rate per minute

  32. Respiratory rate [ Time Frame: day 10 ]
    Respiratory rate per minute

  33. Respiratory rate [ Time Frame: day 21 ]
    Respiratory rate per minute

  34. Respiratory rate [ Time Frame: day 90 ]
    Respiratory rate per minute

  35. cardiac frequency [ Time Frame: Day 0 ]
    cardiac frequency per minute

  36. cardiac frequency [ Time Frame: day 10 ]
    cardiac frequency per minute

  37. cardiac frequency [ Time Frame: day 21 ]
    cardiac frequency per minute

  38. cardiac frequency [ Time Frame: day 90 ]
    cardiac frequency per minute

  39. lung damage [ Time Frame: Day 0 ]
    Lung damage on auscultation in terms of presence/absence

  40. lung damage [ Time Frame: day 10 ]
    Lung damage on auscultation in terms of presence/absence

  41. lung damage [ Time Frame: day 21 ]
    Lung damage on auscultation in terms of presence/absence

  42. lung damage [ Time Frame: day 90 ]
    Lung damage on auscultation in terms of presence/absence

  43. lung evolution [ Time Frame: day 90 ]
    CT san in terms of normal/abnormal (children and pregnant women not concerned)

  44. blood pressure [ Time Frame: Day 0 ]
    Dysatolic/systolic blood pressure in mmHg

  45. blood pressure [ Time Frame: day 10 ]
    Dysatolic/systolic blood pressure in mmHg

  46. blood pressure [ Time Frame: day 21 ]
    Dysatolic/systolic blood pressure in mmHg

  47. blood pressure [ Time Frame: day 90 ]
    Dysatolic/systolic blood pressure in mmHg

  48. body temperature [ Time Frame: Day 0 ]
    Body temperature in °C

  49. body temperature [ Time Frame: day 10 ]
    Body temperature in °C

  50. body temperature [ Time Frame: day 21 ]
    Body temperature in °C

  51. body temperature [ Time Frame: day 90 ]
    Body temperature in °C

  52. clinical exam (skin) [ Time Frame: Day 0 ]
    Skin mottling in terms of presence/absence

  53. clinical exam (skin) [ Time Frame: day 10 ]
    Skin mottling in terms of presence/absence

  54. clinical exam (skin) [ Time Frame: day 21 ]
    Skin mottling in terms of presence/absence

  55. clinical exam (skin) [ Time Frame: day 90 ]
    Skin mottling in terms of presence/absence

  56. clinical exam (polypnea) [ Time Frame: Day 0 ]
    polypnea in terms of presence/absence

  57. clinical exam (polypnea) [ Time Frame: day 10 ]
    polypnea in terms of presence/absence

  58. clinical exam (polypnea) [ Time Frame: day 21 ]
    polypnea in terms of presence/absence

  59. clinical exam (polypnea) [ Time Frame: day 90 ]
    polypnea in terms of presence/absence

  60. denutrition [ Time Frame: Day 0 ]
    denutrition in terms of presence/absence

  61. denutrition [ Time Frame: day 10 ]
    denutrition in terms of presence/absence

  62. denutrition [ Time Frame: day 21 ]
    denutrition in terms of presence/absence

  63. denutrition [ Time Frame: day 90 ]
    denutrition in terms of presence/absence

  64. Antibiotic treatment [ Time Frame: Day 0 ]
    Antibiotic treatment in terms of presence/absence with precision if necessary

  65. Antibiotic treatment [ Time Frame: day 10 ]
    Antibiotic treatment in terms of presence/absence with precision if necessary

  66. Antibiotic treatment [ Time Frame: day 21 ]
    Antibiotic treatment in terms of presence/absence with precision if necessary

  67. Antibiotic treatment [ Time Frame: day 90 ]
    Antibiotic treatment in terms of presence/absence with precision if necessary

  68. Steroidal anti-inflammatory treatment [ Time Frame: Day 0 ]
    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

  69. Steroidal anti-inflammatory treatment [ Time Frame: day 10 ]
    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

  70. Steroidal anti-inflammatory treatment [ Time Frame: day 21 ]
    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

  71. Steroidal anti-inflammatory treatment [ Time Frame: day 90 ]
    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

  72. Anti-diabetic treatment [ Time Frame: Day 0 ]
    Anti-diabetic treatment in terms of presence/absence with precision if necessary

  73. Anti-diabetic treatment [ Time Frame: day 10 ]
    Anti-diabetic treatment in terms of presence/absence with precision if necessary

  74. Anti-diabetic treatment [ Time Frame: day 21 ]
    Anti-diabetic treatment in terms of presence/absence with precision if necessary

  75. Anti-diabetic treatment [ Time Frame: day 90 ]
    Anti-diabetic treatment in terms of presence/absence with precision if necessary

  76. Gastric protector treatment [ Time Frame: Day 0 ]
    Gastric protector treatment in terms of presence/absence with precision if necessary

  77. Gastric protector treatment [ Time Frame: day 10 ]
    Gastric protector treatment in terms of presence/absence with precision if necessary

  78. Gastric protector treatment [ Time Frame: day 21 ]
    Gastric protector treatment in terms of presence/absence with precision if necessary

  79. Gastric protector treatment [ Time Frame: day 90 ]
    Gastric protector treatment in terms of presence/absence with precision if necessary

  80. chills [ Time Frame: Day 0 ]
    chills in terms of presence/absence

  81. chills [ Time Frame: day 10 ]
    chills in terms of presence/absence

  82. chills [ Time Frame: day 21 ]
    chills in terms of presence/absence

  83. chills [ Time Frame: day 90 ]
    chills in terms of presence/absence

  84. Myalgia [ Time Frame: Day 0 ]
    Myalgia in terms of presence/absence

  85. Myalgia [ Time Frame: day 10 ]
    Myalgia in terms of presence/absence

  86. Myalgia [ Time Frame: day 21 ]
    Myalgia in terms of presence/absence

  87. Myalgia [ Time Frame: day 90 ]
    Myalgia in terms of presence/absence

  88. Anorexia [ Time Frame: Day 0 ]
    Anorexia in terms of presence/absence

  89. Anorexia [ Time Frame: day 10 ]
    Anorexia in terms of presence/absence

  90. Anorexia [ Time Frame: day 21 ]
    Anorexia in terms of presence/absence

  91. Anorexia [ Time Frame: day 90 ]
    Anorexia in terms of presence/absence

  92. Rhinitis [ Time Frame: Day 0 ]
    Rhinitis in terms of presence/absence

  93. Rhinitis [ Time Frame: day 10 ]
    Rhinitis in terms of presence/absence

  94. Rhinitis [ Time Frame: day 21 ]
    Rhinitis in terms of presence/absence

  95. Rhinitis [ Time Frame: day 90 ]
    Rhinitis in terms of presence/absence

  96. Confusion [ Time Frame: Day 0 ]
    Confusion in terms of presence/absence

  97. Confusion [ Time Frame: day 10 ]
    Confusion in terms of presence/absence

  98. Confusion [ Time Frame: day 21 ]
    Confusion in terms of presence/absence

  99. Confusion [ Time Frame: day 90 ]
    Confusion in terms of presence/absence

  100. Asthenia [ Time Frame: Day 0 ]
    Asthenia in terms of presence/absence

  101. Asthenia [ Time Frame: day 10 ]
    Asthenia in terms of presence/absence

  102. Asthenia [ Time Frame: day 21 ]
    Asthenia in terms of presence/absence

  103. Asthenia [ Time Frame: day 90 ]
    Asthenia in terms of presence/absence

  104. Falls at home [ Time Frame: Day 0 ]
    Falls at home in terms of presence/absence

  105. Falls at home [ Time Frame: day 10 ]
    Falls at home in terms of presence/absence

  106. Falls at home [ Time Frame: day 21 ]
    Falls at home in terms of presence/absence

  107. Falls at home [ Time Frame: day 90 ]
    Falls at home in terms of presence/absence

  108. Insomnia [ Time Frame: Day 0 ]
    Insomnia in terms of presence/absence

  109. Insomnia [ Time Frame: day 10 ]
    Insomnia in terms of presence/absence

  110. Insomnia [ Time Frame: day 21 ]
    Insomnia in terms of presence/absence

  111. Insomnia [ Time Frame: day 90 ]
    Insomnia in terms of presence/absence

  112. Angina [ Time Frame: Day 0 ]
    Angina in terms of presence/absence

  113. Angina [ Time Frame: day 10 ]
    Angina in terms of presence/absence

  114. Angina [ Time Frame: day 21 ]
    Angina in terms of presence/absence

  115. Angina [ Time Frame: day 90 ]
    Angina in terms of presence/absence

  116. Ageusia [ Time Frame: Day 0 ]
    Ageusia in terms of presence/absence

  117. Ageusia [ Time Frame: day 10 ]
    Ageusia in terms of presence/absence

  118. Ageusia [ Time Frame: day 21 ]
    Ageusia in terms of presence/absence

  119. Ageusia [ Time Frame: day 90 ]
    Ageusia in terms of presence/absence

  120. Respiratory complaints [ Time Frame: Day 0 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  121. Respiratory complaints [ Time Frame: day 2 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  122. Respiratory complaints [ Time Frame: day 4 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  123. Respiratory complaints [ Time Frame: day 6 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  124. Respiratory complaints [ Time Frame: day 8 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  125. Respiratory complaints [ Time Frame: day 10 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  126. Respiratory complaints [ Time Frame: day 21 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  127. Respiratory complaints [ Time Frame: day 90 ]
    Respiratory complaints in term of SRIpr score from 0 to 100

  128. transmission rate [ Time Frame: Day 0 ]
    Rate of viral transmission determine by bioinformatic and statistical analyzes in %

  129. transmission rate [ Time Frame: day 10 ]
    Rate of viral transmission determine by bioinformatic and statistical analyzes in %

  130. transmission rate [ Time Frame: day 21 ]
    Rate of viral transmission determine by bioinformatic and statistical analyzes in %

  131. prolonged viral shedding [ Time Frame: between day 0 and day 21 ]
    Prolonged viral shedding evaluate by RT-PCR (CT value or log10 copies per mL)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597736


Contacts
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Contact: Lise LACLAUTRE +33473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre    +33473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Cécile Henquell         
Sub-Investigator: Olivier Lesens         
Sub-Investigator: Magali Vidal         
Sub-Investigator: Etienne Merlin         
Sub-Investigator: Marc Berger         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Céclie Henquell University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04597736    
Other Study ID Numbers: RBPH 2020 HENQUELL
2020-A02381-38 ( Other Identifier: ANSM )
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
SARS-CoV-2
COVID19
Confirmed case
 Biological collection
contact case
cluster
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases