Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') or or Authorisation for Early Access (AAP). A Prospective Cohort.

简要总结

主要结局

次要结局

• Percentage of patients who died from COVID-19 complications and any other reason(Month 1)
• Virological response(Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients)
• anti-S antibody level(Day 0 and Month 3)
• Percentage of patients hospitalized whatever the reason(Month 1 and 3)
• Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset(Month 1)
• Virological criteria linked to the emergence of resistance(from inclusion until a negative PCR test or Ct ≥31 is obtained)
• Percentage of patients with an WHO score >= 5(Month 1)
• Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events(Month 1)
• Flow cytometry cartography of myeloid response(Day 0, 7 and Month 1)
• 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))
• Time between first symptoms and treatment and the reasons for this delay(Day 0)
• Percentage of patients with positive anti-N and anti-S serology(Day 0 and Month 3)
• 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)
• Flow cytometry cartography of T-lymphocyte response(Day 0, 7 and Month 1)
• Flow cytometry cartography of B-lymphocyte response(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))
• 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))