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 Prospectvie Cohort.
- Conditions
- SARS-CoV InfectionCovid19
- Interventions
- Other: biobank
- Registration Number
- NCT04885452
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- 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 described in the French compassionate program (ATU/AAP)
- Patient participating in another biomedical research with an exclusion period ongoing at inclusion
- Vulnerable patient (adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty)
- Pregnant or breastfeeding woman
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with Xevudy according to the authorisation for early access (AAP) protocol biobank - Patients treated with casirivimab/imdevimab according to the ATU protocol biobank - Patients treated with bamlanivimab/etesevimab according to the ATU protocol biobank - Patients treated with Paxlovid according to the authorisation for early access (AAP) protocol biobank -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Percentage of virological response defined by CT\>=31 or negative PCR test +
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 included developing resistance variants, genotypic and phenotypic characterization of resistance variants
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 Flow cytometry cartography of myeloid (functional subtypes of monocytes and dendritic cells) response
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
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 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
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 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
Trial Locations
- Locations (37)
CH Agen-Nerac
🇫🇷Agen, France
CHU d'Angers
🇫🇷Angers, France
CHR Metz-Thionville
🇫🇷Ars-Laquenexy, France
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
Hôpital Bicêtre - SMIT
🇫🇷Le Kremlin-Bicêtre, France
CHU de Limoges
🇫🇷Limoges, France
Hospices Civils de Lyon (HCL)
🇫🇷Lyon, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
CHRU de Nancy
🇫🇷Nancy, France
Hôpital Lariboisière - SMIT
🇫🇷Paris, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital Bichat Claude-Bernard
🇫🇷Paris, France
Hôpital Bichat Claude-Bernard - SAU
🇫🇷Paris, France
Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Hôpital Saint Antoine - SAU
🇫🇷Paris, France
Hôpital Saint-Louis
🇫🇷Paris, France
Hôpital Universitaire Necker Enfants Malades
🇫🇷Paris, France
CHI Poissy St Germain en Laye
🇫🇷Poissy, France
CHU de Rennes
🇫🇷Rennes, France
CH de Tarbes
🇫🇷Tarbes, France
CHU de Toulouse - IUCT - Oncopole
🇫🇷Toulouse, France
CHU de Toulouse
🇫🇷Toulouse, France
CH de Tourcoing
🇫🇷Tourcoing, France
CHRU de Tours - Hôpital Bretonneau
🇫🇷Tours, France
Hôpitaux Cochin - Port Royal
🇫🇷Paris, France
Hôpital Avicenne
🇫🇷Bobigny, France
CHU de Poitiers
🇫🇷Poitiers, France
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hôpital Bicêtre - Médecine interne
🇫🇷Le Kremlin-Bicêtre, France
CHU de Nîmes
🇫🇷Nîmes, France
Hôpital Tenon
🇫🇷Paris, France
Hôpital Lariboisière - SAU SMUR
🇫🇷Paris, France