SARS-CoV Infection, Covid19
Conditions
Brief summary
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).
Interventions
OTHERbiobank
* 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
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with the criteria for COVID-19 treatment within the French compassionate program (ATU/AAP) * Adults covered by the French social health coverage * Adults who signed the informed consent form
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Month 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients hospitalized whatever the reason | Month 1 and 3 | — |
| Percentage of patients with an WHO score >= 5 | Month 1 | — |
| Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset | Month 1 | — |
| Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events | Month 1 | — |
| Time between first symptoms and treatment and the reasons for this delay | Day 0 | — |
| Virological response | Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients | Percentage of virological response defined by CT\>=31 or negative PCR test + |
| Virological criteria linked to the emergence of resistance | from inclusion until a negative PCR test or Ct ≥31 is obtained | Percentage of patients included developing resistance variants, genotypic and phenotypic characterization of resistance variants |
| Percentage of patients with positive anti-N and anti-S serology | Day 0 and Month 3 | — |
| Percentage of patients who died from COVID-19 complications and any other reason | Month 1 | — |
| Flow cytometry cartography of myeloid response | Day 0, 7 and Month 1 | Flow cytometry cartography of myeloid (functional subtypes of monocytes and dendritic cells) response |
| Flow cytometry cartography of T-lymphocyte response | Day 0, 7 and Month 1 | 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 |
| Flow cytometry cartography of B-lymphocyte response | Day 0, 7 and Month 1 | Flow cytometry cartography of B-lymphocyte (transitional, naïve, memory T-lymphocyte with or without isotypic switching, plasmablasts) response |
| 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 | 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 | from inclusion until the end of the follow-up (Month 1 or Month 3) | 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 |
| 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 | from inclusion until the end of the follow-up (Month 1 or Month 3) | 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 |
| Clinical and biological predictors (clinical parameters, treatment received, virological criteria) of viral response (viral genotypes, emergence of resistant strains) | from inclusion until the end of the follow-up (Month 1 or Month 3) | 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 |
| anti-S antibody level | Day 0 and Month 3 | — |
Countries
France
Outcome results
None listed