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.

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: SARS-CoV Infection; Covid19

Treatments: Other: biobank

Study type: Observational

Funder types: Other

Identifiers

NCT04885452

ANRS0003S COCOPREV

Details and patient eligibility

About

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).

Enrollment: 756 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

756 participants in 4 patient groups

Patients treated with casirivimab/imdevimab according to the ATU protocol

Treatment:

Other: biobank

Patients treated with bamlanivimab/etesevimab according to the ATU protocol

Treatment:

Other: biobank

Patients treated with Xevudy according to the authorisation for early access (AAP) protocol

Treatment:

Other: biobank

Patients treated with Paxlovid according to the authorisation for early access (AAP) protocol

Treatment:

Other: biobank