Predictive Immune Biomarkers for COVID-19 Pathogenesis
الكلمات الدالة
نبذة مختصرة
وصف
The World Health Organization (WHO) has recently declared pandemic the coronavirus disease 2019 (COVID-19) due to the causative severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 (SARS-CoV-2). People infected with SARS-CoV-2 vary in severity from being asymptomatic to having severe pneumonia and ARDS. Predictive markers of clinical worsening after admission are lacking. Clinical deterioration often coincides with the development of host antiviral immune responses, suggesting that the inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses causing lung functional disability. Relevant therapeutic strategies are still under investigation. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions.
On this basis, the project aims to create a prospective cohort of biological samples collected from COVID-19 patients followed at the Toulouse University Hospital.
This cohort will collect and cryopreserve biological samples (33 mL), including plasma and peripheral blood mononuclear cells (PBMCs), on admission (day 0) and longitudinally (day 4, 8 12 and in discharge) and will allow us to investigate our primary and secondary objectives. This cohort will be bridged with a clinical cohort in order to have a very well-defined population of COVID-19 patients with the following outcomes:
- Patients with severe disease requiring on admission intensive care unit (ICU) management for ARDS,
- Non-severe hospitalized patients with secondary clinical worsening requiring ICU management,
- Non-severe hospitalized patients without clinical worsening requiring ICU management.
In addition, mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited and blood samples will be collected on their first consultation and 10 to 14 days later in the frame of a medical surveillance program.
تواريخ
آخر التحقق: | 04/30/2020 |
تم الإرسال لأول مرة: | 05/04/2020 |
تم إرسال التسجيل المقدر: | 05/10/2020 |
أول نشر: | 05/11/2020 |
تم إرسال آخر تحديث: | 05/10/2020 |
آخر تحديث تم نشره: | 05/11/2020 |
تاريخ بدء الدراسة الفعلي: | 05/11/2020 |
تاريخ الإنجاز الأساسي المقدر: | 12/30/2021 |
التاريخ المتوقع لانتهاء الدراسة: | 12/30/2021 |
حالة أو مرض
التدخل / العلاج
Biological: hospitalized patients
Biological: healthcare workers
مرحلة
مجموعات الذراع
ذراع | التدخل / العلاج |
---|---|
Experimental: hospitalized patients very well-defined population of COVID-19 patients with the following outcomes:
Patients with severe disease requiring on admission ICU management for ARDS,
Non-severe hospitalized patients with secondary clinical worsening requiring ICU management,
Non-severe hospitalized patients without clinical worsening requiring ICU management. | Biological: hospitalized patients 33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge) |
Experimental: healthcare workers mildly symptomatic patients among healthcare workers attending outpatient dedicated clinics will be recruited | Biological: healthcare workers 33 mL of blood collected on their first consultation and 10 to 14 days later |
معايير الأهلية
الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
الأجناس المؤهلة للدراسة | All |
يقبل المتطوعين الأصحاء | نعم |
المعايير | Inclusion Criteria: For COVID-19 hospitalized patients - Polymerase chain reaction (PCR) proven SARS-CoV-2 infection - Participation to Toulouse clinical cohort - Having signed consent for inclusion in the Toulouse biobanks For COVID-19 healthcare workers attending dedicated clinics - PCR proven SARS-CoV-2 infection - Having signed consent for inclusion in the Toulouse biobanks Exclusion Criteria: - Pregnancy or breastfeeding - Participation in another interventional clinical study involving exploratory treatment or blood sampling. |
النتيجة
مقاييس النتائج الأولية
1. Immune signature [Day 0]
2. Dosage of cytokines and chemokines in plasma samples [Day 0]
مقاييس النتائج الثانوية
1. Immune signature [Day 2]
2. Immune signature [Day 4]
3. Immune signature [Day 8]
4. Immune signature [Day 12]
5. Immune signature [Day 30 (or in discharge)]
6. Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity [Day 0]
7. Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity [Day 2]
8. Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity [Day 4]
9. Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity [Day 8]
10. Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity [Day 12]
11. Analysis of the early dynamics of SARS-CoV-2-specific humoral immunity [Day 30 (or in discharge)]