The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viralpneumopathy that can progress to acute respiratory distress syndrome (ARDS). Thehost-pathogen relationships and the physiopathological mechanisms underlying the clinicalaggravation of COVID-19 patients remain misunderstood. The project aim is to create aprospective cohort of biological samples collected from well characterized COVID-19patients. This project aims first to identify based on these samples an early immunesignature predictive of clinical worsening of COVID-19 patients in order to improve theirmanagement, and secondarily to better understand pathophysiological mechanisms underlyingthe different phases of the disease in order to identify innovative therapeutic targetsand vaccine perspectives.
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.
Biological: Blood collection on admission and longitudinally
33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in
discharge)
Biological: Blood collection on their first consultation and 10 to 14 days later
33 mL of blood collected on their first consultation and 10 to 14 days later
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.
Purpan University Hospital
Toulouse, France
Guillaume MARTIN-BLONDEL, MD PhD, Principal Investigator
University Hospital, Toulouse