AzTrials
AzTrials

Covid19COVIDCOLLECTNCT04597736

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

A study testing Biological collection with nasopharyngeal samples, saliva, blood, stool and urine in people with Covid19 and Contact Case, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Covid19, Contact Case
What is being tested?
Biological collection with nasopharyngeal samples, saliva, blood, stool and urine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteFrance
Study dates
Nov 2020to Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lise LACLAUTRE contact

+33473754963

promo_interne_drci@chu-clermontferrand.fr

France1 site

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr

    Cécile Henquell

Other trials in France

About this study

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

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).

Read the 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.

Being tested
Biological collection with nasopharyngeal samples, saliva, blood, stool and urine
Keywords
SARS-CoV-2, COVID19, Confirmed case, Biological collection, contact case, cluster
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological collection with nasopharyngeal samples, saliva, blood, stool and urineBiological

    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.

Study groups in NCT04597736
Study groupRoleWhat they receive
cohortExperimentalBiological collection with nasopharyngeal samples, saliva, blood, stool and urine
Receives: Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virological profile

    Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)

    Measured: Day 0

  2. Virological profile

    Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)

    Measured: Day 10

  3. Virological profile

    Nasopharyngeal SARS-CoV-2 viral load at day 0 by RT-PCR (in log or ΔCT)

    Measured: Day 21

  4. Virological profile (serology)

    SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)

    Measured: Day 0

  5. Virological profile (serology)

    SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)

    Measured: Day 10

  6. Virological profile (serology)

    SARS-CoV-2 serology by enzyme-linked immunosorbent assays or magnetic chemiluminescence enzyme immunoassay (IgG and IgM titers)

    Measured: Day 21

  7. Immunological profile with blood level for markers of inflammation (cytokine)

    cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL

    Measured: Day 0

  8. Immunological profile with blood level for markers of inflammation (cytokine)

    cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL

    Measured: Day 10

  9. Immunological profile with blood level for markers of inflammation (cytokine)

    cytokine panel by flow cytometry or enzyme-linked immunosorbent assay in pg/mL

    Measured: Day 21

  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 %

    Measured: Day 0

  11. Immunological profile with blood level for markers of inflammation

    markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %

    Measured: Day 10

  12. Immunological profile with blood level for markers of inflammation

    markers on immune cell subpopulation by RT-PCR or flow cytometry in CT value or %

    Measured: Day 21

  13. Biochemical profile by blood dosage of CRP

    CRP in mg/l

    Measured: Day 0

  14. Biochemical profile by blood dosage of CRP

    CRP in mg/l

    Measured: Day 10

  15. Biochemical profile by blood dosage of CRP

    CRP in mg/l

    Measured: Day 21

  16. Biochemical profile by blood dosage of CRP

    CRP in mg/l

    Measured: Day 90

  17. Biochemical profile by blood dosage of ASAT/ALAT

    ASAT/ALAT in U/L

    Measured: Day 0

  18. Biochemical profile by blood dosage of ASAT/ALAT

    ASAT/ALAT in U/L

    Measured: Day 10

  19. Biochemical profile by blood dosage of ASAT/ALAT

    ASAT/ALAT in U/L

    Measured: Day 21

  20. Biochemical profile by blood dosage of ASAT/ALAT

    ASAT/ALAT in U/L

    Measured: Day 90

  21. Biochemical profile by blood dosage of LDH

    LDH in U/L

    Measured: Day 0

  22. Biochemical profile by blood dosage of LDH

    LDH in U/L

    Measured: Day 10

  23. Biochemical profile by blood dosage of LDH

    LDH in U/L

    Measured: Day 21

  24. Biochemical profile by blood dosage of LDH

    LDH in U/L

    Measured: Day 90

  25. Biochemical profile by blood dosage of Lactate

    Lactate in mg/l

    Measured: Day 0

  26. Biochemical profile by blood dosage of Lactate

    Lactate in mg/l

    Measured: Day 10

  27. Biochemical profile by blood dosage of Lactate

    Lactate in mg/l

    Measured: Day 21

  28. Biochemical profile by blood dosage of Lactate

    Lactate in mg/l

    Measured: Day 90

  29. Biochemical profile by blood dosage of D-Dimer

    D-Dimer in µg/L

    Measured: Day 0

  30. Biochemical profile by blood dosage of D-Dimer

    D-Dimer in µg/L

    Measured: Day 10

  31. Biochemical profile by blood dosage of D-Dimer

    D-Dimer in µg/L

    Measured: Day 21

  32. Biochemical profile by blood dosage of D-Dimer

    D-Dimer in µg/L

    Measured: Day 90

  33. Biochemical profile by blood dosage of Troponin

    Troponin in µg/L

    Measured: Day 0

  34. Biochemical profile by blood dosage of Troponin

    Troponin in µg/L

    Measured: Day 10

  35. Biochemical profile by blood dosage of Troponin

    Troponin in µg/L

    Measured: Day 21

  36. Biochemical profile by blood dosage of Troponin

    Troponin in µg/L

    Measured: Day 90

  37. Biochemical profile by blood dosage of Ferritin

    Ferritin in µg/L

    Measured: Day 0

  38. Biochemical profile by blood dosage of Ferritin

    Ferritin in µg/L

    Measured: Day 10

  39. Biochemical profile by blood dosage of Ferritin

    Ferritin in µg/L

    Measured: Day 21

  40. Biochemical profile by blood dosage of RAGE

    RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein

    Measured: Day 0

  41. Biochemical profile by blood dosage of RAGE

    RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein

    Measured: Day 10

  42. Biochemical profile by blood dosage of RAGE

    RAGE (receptor of advanced end glycation products) by enzyme-linked immunosorbent assays in pg/mg total protein

    Measured: Day 21

  43. Biochemical profile by blood dosage of SUPAR

    SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein

    Measured: Day 0

  44. Biochemical profile by blood dosage of SUPAR

    SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein

    Measured: Day 10

  45. Biochemical profile by blood dosage of SUPAR

    SUPAR (soluble urokinase plasminogen activator receptor) by enzyme-linked immunosorbent assays in pg/mg total protein

    Measured: Day 21

  46. Haematological profile by blood dosage of leukocytes

    leukocytes in Giga/L

    Measured: Day 0

  47. Haematological profile by blood dosage of leukocytes

    leukocytes in Giga/L

    Measured: Day 10

  48. Haematological profile by blood dosage of leukocytes

    leukocytes in Giga/L

    Measured: Day 21

  49. Haematological profile by blood dosage of leukocytes

    leukocytes in Giga/L

    Measured: Day 90

  50. Haematological profile by blood dosage of Red blood cells

    Red blood cells in Tera/L

    Measured: Day 0

  51. Haematological profile by blood dosage of Red blood cells

    Red blood cells in Tera/L

    Measured: Day 10

  52. Haematological profile by blood dosage of Red blood cells

    Red blood cells in Tera/L

    Measured: Day 21

  53. Haematological profile by blood dosage of Red blood cells

    Red blood cells in Tera/L

    Measured: Day 90

  54. Haematological profile by blood dosage of Hemoglobin

    Hemoglobin in g/dL

    Measured: Day 0

  55. Haematological profile by blood dosage of Hemoglobin

    Hemoglobin in g/dL

    Measured: Day 10

  56. Haematological profile by blood dosage of Hemoglobin

    Hemoglobin in g/dL

    Measured: Day 21

  57. Haematological profile by blood dosage of Hemoglobin

    Hemoglobin in g/dL

    Measured: Day 90

  58. Haematological profile by blood dosage of Hematocrit

    Hematocrit in %

    Measured: Day 0

  59. Haematological profile by blood dosage of Hematocrit

    Hematocrit in %

    Measured: Day 10

  60. Haematological profile by blood dosage of Hematocrit

    Hematocrit in %

    Measured: Day 21

  61. Haematological profile by blood dosage of Hematocrit

    Hematocrit in %

    Measured: Day 90

  62. Haematological profile by blood dosage of Mean corpuscular volume

    Mean corpuscular volume in fL

    Measured: Day 0

  63. Haematological profile by blood dosage of Mean corpuscular volume

    Mean corpuscular volume in fL

    Measured: Day 10

  64. Haematological profile by blood dosage of Mean corpuscular volume

    Mean corpuscular volume in fL

    Measured: Day 21

  65. Haematological profile by blood dosage of Mean corpuscular volume

    Mean corpuscular volume in fL

    Measured: Day 90

  66. Haematological profile by blood dosage of Mean corpuscular hemoglobin

    Mean corpuscular hemoglobin in pg

    Measured: Day 0

  67. Haematological profile by blood dosage of Mean corpuscular hemoglobin

    Mean corpuscular hemoglobin in pg

    Measured: Day 10

  68. Haematological profile by blood dosage of Mean corpuscular hemoglobin

    Mean corpuscular hemoglobin in pg

    Measured: Day 21

  69. Haematological profile by blood dosage of Mean corpuscular hemoglobin

    Mean corpuscular hemoglobin in pg

    Measured: Day 90

  70. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin

    Average corpuscular concentration of haemoglobin in g/dL

    Measured: Day 0

  71. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin

    Average corpuscular concentration of haemoglobin in g/dL

    Measured: Day 10

  72. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin

    Average corpuscular concentration of haemoglobin in g/dL

    Measured: Day 21

  73. Haematological profile by blood dosage of average corpuscular concentration of haemoglobin

    Average corpuscular concentration of haemoglobin in g/dL

    Measured: Day 90

  74. Haematological profile by blood dosage of polynuclear neutrophil

    polynuclear neutrophil in Giga/L

    Measured: Day 0

  75. Haematological profile by blood dosage of polynuclear neutrophil

    polynuclear neutrophil in Giga/L

    Measured: Day 10

  76. Haematological profile by blood dosage of polynuclear neutrophil

    polynuclear neutrophil in Giga/L

    Measured: Day 21

  77. Haematological profile by blood dosage of polynuclear neutrophil

    polynuclear neutrophil in Giga/L

    Measured: Day 90

  78. Haematological profile by blood dosage of polynuclear eosinophils

    polynuclear eosinophils in Giga/L

    Measured: Day 0

  79. Haematological profile by blood dosage of polynuclear eosinophils

    polynuclear eosinophils in Giga/L

    Measured: Day 10

  80. Haematological profile by blood dosage of polynuclear eosinophils

    polynuclear eosinophils in Giga/L

    Measured: Day 21

  81. Haematological profile by blood dosage of polynuclear eosinophils

    polynuclear eosinophils in Giga/L

    Measured: Day 90

  82. Haematological profile by blood dosage of polynuclear basophils

    polynuclear basophils in Giga/L

    Measured: Day 0

  83. Haematological profile by blood dosage of polynuclear basophils

    polynuclear basophils in Giga/L

    Measured: Day 10

  84. Haematological profile by blood dosage of polynuclear basophils

    polynuclear basophils in Giga/L

    Measured: Day 21

  85. Haematological profile by blood dosage of polynuclear basophils

    polynuclear basophils in Giga/L

    Measured: Day 90

  86. Haematological profile by blood dosage of lymphocytes

    lymphocytes in Giga/L

    Measured: Day 0

  87. Haematological profile by blood dosage of lymphocytes

    lymphocytes in Giga/L

    Measured: Day 10

  88. Haematological profile by blood dosage of lymphocytes

    lymphocytes in Giga/L

    Measured: Day 21

  89. Haematological profile by blood dosage of lymphocytes

    lymphocytes in Giga/L

    Measured: Day 90

  90. Haematological profile by blood dosage of monocytes

    monocytes in Giga/L

    Measured: Day 90

  91. Haematological profile by blood dosage of monocytes

    monocytes in Giga/L

    Measured: Day 0

  92. Haematological profile by blood dosage of monocytes

    monocytes in Giga/L

    Measured: Day 10

  93. Haematological profile by blood dosage of monocytes

    monocytes in Giga/L

    Measured: Day 21

  94. Haematological profile by blood dosage of platelets

    platelets in Giga/L

    Measured: Day 0

  95. Haematological profile by blood dosage of platelets

    platelets in Giga/L

    Measured: Day 10

  96. Haematological profile by blood dosage of platelets

    platelets in Giga/L

    Measured: Day 21

  97. Haematological profile by blood dosage of platelets

    platelets in Giga/L

    Measured: Day 90

  98. Haematological profile by blood dosage of activated partial thromboplastin time

    activated partial thromboplastin time in second/witness

    Measured: Day 0

  99. Haematological profile by blood dosage of activated partial thromboplastin time

    activated partial thromboplastin time in second/witness

    Measured: Day 10

  100. Haematological profile by blood dosage of activated partial thromboplastin time

    activated partial thromboplastin time in second/witness

    Measured: Day 21

  101. Haematological profile by blood dosage of activated partial thromboplastin time

    activated partial thromboplastin time in second/witness

    Measured: Day 90

  102. Haematological profile by blood dosage of fibrinogen

    fibrinogen in g/L

    Measured: Day 0

  103. Haematological profile by blood dosage of fibrinogen

    fibrinogen in g/L

    Measured: Day 10

  104. Haematological profile by blood dosage of fibrinogen

    fibrinogen in g/L

    Measured: Day 21

  105. Haematological profile by blood dosage of fibrinogen

    fibrinogen in g/L

    Measured: Day 90

  106. Haematological profile by blood dosage of factor V

    factor V in %

    Measured: Day 0

  107. Haematological profile by blood dosage of factor V

    factor V in %

    Measured: Day 10

  108. Haematological profile by blood dosage of factor V

    factor V in %

    Measured: Day 21

  109. Haematological profile by blood dosage of factor V

    factor V in %

    Measured: Day 90

Secondary outcomes (131)

  1. SARS-CoV-2 salivary viral load

    RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL

    Measured: Day 0

  2. SARS-CoV-2 salivary viral load

    RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL

    Measured: Day 10

  3. SARS-CoV-2 salivary viral load

    RT-PCR SARS-CoV-2 on saliva in ΔCT value or log10 copies per mL

    Measured: Day 21

  4. Comparison of viral sequences

    bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)

    Measured: Day 0

  5. Comparison of viral sequences

    bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)

    Measured: Day 10

  6. Comparison of viral sequences

    bioinformatic and statistical analyzes of viral sequences (arbitrary unit and p-values)

    Measured: Day 21

  7. microbiota analysis

    bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)

    Measured: Day 0

  8. microbiota analysis

    bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)

    Measured: Day 10

  9. microbiota analysis

    bioinformatic and statistical analyzes of microbiota (arbitrary unit and p-values)

    Measured: Day 21

  10. environmental and societal factors (EPICE)

    EPICE score (Assessment of precariousness and health inequalities in examination centers Health) at day 0 from 0 to 100

    Measured: Day 0

  11. environmental and societal factors

    eating habits

    Measured: Day 0

  12. environmental and societal factors

    eating habits

    Measured: day 10

  13. environmental and societal factors

    eating habits

    Measured: day 21

  14. environmental and societal factors

    eating habits

    Measured: day 90

  15. environmental and societal factors (SF-36)

    SF-36 score (quality of life by Gardenal O) from 0 to 100

    Measured: Day 0

  16. environmental and societal factors (SF-36)

    SF-36 score (quality of life by Gardenal O) from 0 to 100

    Measured: day 10

  17. environmental and societal factors (SF-36)

    SF-36 score (quality of life by Gardenal O) from 0 to 100

    Measured: day 21

  18. environmental and societal factors (SF-36)

    SF-36 score (quality of life by Gardenal O) from 0 to 100

    Measured: day 90

  19. 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

    Measured: Day 0

  20. 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

    Measured: day 10

  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

    Measured: day 21

  22. 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

    Measured: day 90

  23. body weight

    body weight in kg

    Measured: Day 0

  24. body weight

    body weight in kg

    Measured: day 10

  25. body weight

    body weight in kg

    Measured: day 21

  26. body weight

    body weight in kg

    Measured: day 90

  27. oxygen saturation

    oxygen saturation in %

    Measured: Day 0

  28. oxygen saturation

    oxygen saturation in %

    Measured: day 10

  29. oxygen saturation

    oxygen saturation in %

    Measured: day 21

  30. oxygen saturation

    oxygen saturation in %

    Measured: day 90

  31. Respiratory rate

    Respiratory rate per minute

    Measured: Day 0

  32. Respiratory rate

    Respiratory rate per minute

    Measured: day 10

  33. Respiratory rate

    Respiratory rate per minute

    Measured: day 21

  34. Respiratory rate

    Respiratory rate per minute

    Measured: day 90

  35. cardiac frequency

    cardiac frequency per minute

    Measured: Day 0

  36. cardiac frequency

    cardiac frequency per minute

    Measured: day 10

  37. cardiac frequency

    cardiac frequency per minute

    Measured: day 21

  38. cardiac frequency

    cardiac frequency per minute

    Measured: day 90

  39. lung damage

    Lung damage on auscultation in terms of presence/absence

    Measured: Day 0

  40. lung damage

    Lung damage on auscultation in terms of presence/absence

    Measured: day 10

  41. lung damage

    Lung damage on auscultation in terms of presence/absence

    Measured: day 21

  42. lung damage

    Lung damage on auscultation in terms of presence/absence

    Measured: day 90

  43. lung evolution

    CT san in terms of normal/abnormal (children and pregnant women not concerned)

    Measured: day 90

  44. blood pressure

    Dysatolic/systolic blood pressure in mmHg

    Measured: Day 0

  45. blood pressure

    Dysatolic/systolic blood pressure in mmHg

    Measured: day 10

  46. blood pressure

    Dysatolic/systolic blood pressure in mmHg

    Measured: day 21

  47. blood pressure

    Dysatolic/systolic blood pressure in mmHg

    Measured: day 90

  48. body temperature

    Body temperature in °C

    Measured: Day 0

  49. body temperature

    Body temperature in °C

    Measured: day 10

  50. body temperature

    Body temperature in °C

    Measured: day 21

  51. body temperature

    Body temperature in °C

    Measured: day 90

  52. clinical exam (skin)

    Skin mottling in terms of presence/absence

    Measured: Day 0

  53. clinical exam (skin)

    Skin mottling in terms of presence/absence

    Measured: day 10

  54. clinical exam (skin)

    Skin mottling in terms of presence/absence

    Measured: day 21

  55. clinical exam (skin)

    Skin mottling in terms of presence/absence

    Measured: day 90

  56. clinical exam (polypnea)

    polypnea in terms of presence/absence

    Measured: Day 0

  57. clinical exam (polypnea)

    polypnea in terms of presence/absence

    Measured: day 10

  58. clinical exam (polypnea)

    polypnea in terms of presence/absence

    Measured: day 21

  59. clinical exam (polypnea)

    polypnea in terms of presence/absence

    Measured: day 90

  60. denutrition

    denutrition in terms of presence/absence

    Measured: Day 0

  61. denutrition

    denutrition in terms of presence/absence

    Measured: day 10

  62. denutrition

    denutrition in terms of presence/absence

    Measured: day 21

  63. denutrition

    denutrition in terms of presence/absence

    Measured: day 90

  64. Antibiotic treatment

    Antibiotic treatment in terms of presence/absence with precision if necessary

    Measured: Day 0

  65. Antibiotic treatment

    Antibiotic treatment in terms of presence/absence with precision if necessary

    Measured: day 10

  66. Antibiotic treatment

    Antibiotic treatment in terms of presence/absence with precision if necessary

    Measured: day 21

  67. Antibiotic treatment

    Antibiotic treatment in terms of presence/absence with precision if necessary

    Measured: day 90

  68. Steroidal anti-inflammatory treatment

    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

    Measured: Day 0

  69. Steroidal anti-inflammatory treatment

    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

    Measured: day 10

  70. Steroidal anti-inflammatory treatment

    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

    Measured: day 21

  71. Steroidal anti-inflammatory treatment

    Steroidal anti-inflammatory treatment in terms of presence/absence with precision if necessary

    Measured: day 90

  72. Anti-diabetic treatment

    Anti-diabetic treatment in terms of presence/absence with precision if necessary

    Measured: Day 0

  73. Anti-diabetic treatment

    Anti-diabetic treatment in terms of presence/absence with precision if necessary

    Measured: day 10

  74. Anti-diabetic treatment

    Anti-diabetic treatment in terms of presence/absence with precision if necessary

    Measured: day 21

  75. Anti-diabetic treatment

    Anti-diabetic treatment in terms of presence/absence with precision if necessary

    Measured: day 90

  76. Gastric protector treatment

    Gastric protector treatment in terms of presence/absence with precision if necessary

    Measured: Day 0

  77. Gastric protector treatment

    Gastric protector treatment in terms of presence/absence with precision if necessary

    Measured: day 10

  78. Gastric protector treatment

    Gastric protector treatment in terms of presence/absence with precision if necessary

    Measured: day 21

  79. Gastric protector treatment

    Gastric protector treatment in terms of presence/absence with precision if necessary

    Measured: day 90

  80. chills

    chills in terms of presence/absence

    Measured: Day 0

  81. chills

    chills in terms of presence/absence

    Measured: day 10

  82. chills

    chills in terms of presence/absence

    Measured: day 21

  83. chills

    chills in terms of presence/absence

    Measured: day 90

  84. Myalgia

    Myalgia in terms of presence/absence

    Measured: Day 0

  85. Myalgia

    Myalgia in terms of presence/absence

    Measured: day 10

  86. Myalgia

    Myalgia in terms of presence/absence

    Measured: day 21

  87. Myalgia

    Myalgia in terms of presence/absence

    Measured: day 90

  88. Anorexia

    Anorexia in terms of presence/absence

    Measured: Day 0

  89. Anorexia

    Anorexia in terms of presence/absence

    Measured: day 10

  90. Anorexia

    Anorexia in terms of presence/absence

    Measured: day 21

  91. Anorexia

    Anorexia in terms of presence/absence

    Measured: day 90

  92. Rhinitis

    Rhinitis in terms of presence/absence

    Measured: Day 0

  93. Rhinitis

    Rhinitis in terms of presence/absence

    Measured: day 10

  94. Rhinitis

    Rhinitis in terms of presence/absence

    Measured: day 21

  95. Rhinitis

    Rhinitis in terms of presence/absence

    Measured: day 90

  96. Confusion

    Confusion in terms of presence/absence

    Measured: Day 0

  97. Confusion

    Confusion in terms of presence/absence

    Measured: day 10

  98. Confusion

    Confusion in terms of presence/absence

    Measured: day 21

  99. Confusion

    Confusion in terms of presence/absence

    Measured: day 90

  100. Asthenia

    Asthenia in terms of presence/absence

    Measured: Day 0

  101. Asthenia

    Asthenia in terms of presence/absence

    Measured: day 10

  102. Asthenia

    Asthenia in terms of presence/absence

    Measured: day 21

  103. Asthenia

    Asthenia in terms of presence/absence

    Measured: day 90

  104. Falls at home

    Falls at home in terms of presence/absence

    Measured: Day 0

  105. Falls at home

    Falls at home in terms of presence/absence

    Measured: day 10

  106. Falls at home

    Falls at home in terms of presence/absence

    Measured: day 21

  107. Falls at home

    Falls at home in terms of presence/absence

    Measured: day 90

  108. Insomnia

    Insomnia in terms of presence/absence

    Measured: Day 0

  109. Insomnia

    Insomnia in terms of presence/absence

    Measured: day 10

  110. Insomnia

    Insomnia in terms of presence/absence

    Measured: day 21

  111. Insomnia

    Insomnia in terms of presence/absence

    Measured: day 90

  112. Angina

    Angina in terms of presence/absence

    Measured: Day 0

  113. Angina

    Angina in terms of presence/absence

    Measured: day 10

  114. Angina

    Angina in terms of presence/absence

    Measured: day 21

  115. Angina

    Angina in terms of presence/absence

    Measured: day 90

  116. Ageusia

    Ageusia in terms of presence/absence

    Measured: Day 0

  117. Ageusia

    Ageusia in terms of presence/absence

    Measured: day 10

  118. Ageusia

    Ageusia in terms of presence/absence

    Measured: day 21

  119. Ageusia

    Ageusia in terms of presence/absence

    Measured: day 90

  120. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: Day 0

  121. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 2

  122. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 4

  123. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 6

  124. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 8

  125. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 10

  126. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 21

  127. Respiratory complaints

    Respiratory complaints in term of SRIpr score from 0 to 100

    Measured: day 90

  128. transmission rate

    Rate of viral transmission determine by bioinformatic and statistical analyzes in %

    Measured: Day 0

  129. transmission rate

    Rate of viral transmission determine by bioinformatic and statistical analyzes in %

    Measured: day 10

  130. transmission rate

    Rate of viral transmission determine by bioinformatic and statistical analyzes in %

    Measured: day 21

  131. prolonged viral shedding

    Prolonged viral shedding evaluate by RT-PCR (CT value or log10 copies per mL)

    Measured: between day 0 and day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04597736
Sponsor's protocol ID
RBPH 2020 HENQUELL
Other IDs
2020-A02381-38
Acronym
COVIDCOLLECT
Status last verified
Sep 2020
First submitted
2 Oct 2020
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biological collection with nasopharyngeal samples, saliva, blood, stool and urine in people with Covid19 and Contact Case, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virological profile (time frame: Day 0). The study lists 109 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04597736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in