This is a prospective, multicentric, non comparative study aiming to evaluate the clinical and virological evolution of high-risk patients infected with SARS-CoV-2 treated withtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') or authorisation for early access (AAP) delivered by the French drug agency (ANSM).
Study Type
OBSERVATIONAL
Enrollment
756
* Blood samples (biobank) at Day 0, Day 7, Month 1 and possibly Month 3 (only for the first 100 participants) (serum, plasma and whole blood) * For participants in the immunological ancillary study: additional blood sampling at Day 0, Day 7 and Month 1 (PBMC) * Nasopharyngeal swabs: Day 0, Day 7 (Day 14 and Day 21 if RT-PCR positive respectively at Day 7 and Day 14) * Specific nasopharyngeal swabs in hospitalized patients: Day 3, Day 5
CH Agen-Nerac
Agen, France
CHU d'Angers
Angers, France
CHR Metz-Thionville
Ars-Laquenexy, France
Hôpital Avicenne
Bobigny, France
CHU de Bordeaux
Bordeaux, France
CHU Gabriel Montpied
Clermont-Ferrand, France
Percentage of patients hospitalized (if the patient was outpatient) or whose hospitalization was extended for complications from COVID-19 within 1 month of symtoms' onset.
Time frame: Month 1
Percentage of patients hospitalized whatever the reason
Time frame: Month 1 and 3
Percentage of patients with an WHO score >= 5
Time frame: Month 1
Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset
Time frame: Month 1
Percentage of patients who died from COVID-19 complications and any other reason
Time frame: Month 1
Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events
Time frame: Month 1
Time between first symptoms and treatment and the reasons for this delay
Time frame: Day 0
Virological response
Percentage of virological response defined by CT\>=31 or negative PCR test +
Time frame: Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients
Virological criteria linked to the emergence of resistance
Percentage of patients included developing resistance variants, genotypic and phenotypic characterization of resistance variants
Time frame: from inclusion until a negative PCR test or Ct ≥31 is obtained
Percentage of patients with positive anti-N and anti-S serology
Time frame: Day 0 and Month 3
anti-S antibody level
Time frame: Day 0 and Month 3
Flow cytometry cartography of myeloid response
Flow cytometry cartography of myeloid (functional subtypes of monocytes and dendritic cells) response
Time frame: Day 0, 7 and Month 1
Flow cytometry cartography of T-lymphocyte response
Flow cytometry cartography of T-lymphocyte (conventional T-lymphocytes by identifying naïve, memory and effector Th1, Th2, Tfh and Th17 T-lymphocytes, NK and gamma-delta T-lymphocytes, regulatory T-lymphocytes; surface and intracellular markers) response
Time frame: Day 0, 7 and Month 1
Flow cytometry cartography of B-lymphocyte response
Flow cytometry cartography of B-lymphocyte (transitional, naïve, memory T-lymphocyte with or without isotypic switching, plasmablasts) response
Time frame: Day 0, 7 and Month 1
Dosing of a wide range of cytokines and chemokines (IFNalpha, IFNgamma, IL-6, IL-1, IL-8, IL-15, IL-18, IL1-RA, IL-7, IL-10, CXCL10, CXCL13, CCL2 and CCL3) using the Meso Scale Discovery approach
Time frame: Day 0, 7 and Month 1
Clinical and biological predictors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants) of the onset of complications from COVID19, hospitalization, death
Identication of clinical and biological predictors of the onset of complications from COVID19, hospitalization, death by a logistic model or survival model (RMST): the response variable is the occurrence of a complication, hospitalization, death or the average survival at 1 month on these different criteria; the covariates are the parameters at inclusion, the treatment received, the virological criteria (CT, variants) which can be considered as a time-dependent covariate
Time frame: from inclusion until the end of the follow-up (Month 1 or Month 3)
Clinical and biological predictive factors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants)) linked to the neutralizing serological response: non-response, duration of the response
Identification of clinical and biological predictive factors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants)) linked to the neutralizing serological response: non-response, duration of the response by a logistic model or mixed model for repeated measures
Time frame: from inclusion until the end of the follow-up (Month 1 or Month 3)
Clinical and biological predictors (clinical parameters, treatment received, virological criteria) of viral response (viral genotypes, emergence of resistant strains)
Identification of clinical and biological predictive factors related to the virological response (viral genotypes, emergence of resistant strains) by a logistic model: the response variable is RT-PCR negativation at D7 (or CT≥31), the covariates are the parameters at inclusion, the treatment received, the virological criteria at baseline
Time frame: from inclusion until the end of the follow-up (Month 1 or Month 3)
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Centre Hospitalier Sud Francilien - Hématologie
Corbeil-Essonnes, France
Centre Hospitalier Sud Francilien - Néphrologie
Corbeil-Essonnes, France
CHU de Dijon
Dijon, France
CHU de Martinique
Fort-de-France, France
...and 27 more locations