NCT04885452

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.

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 756 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• SARS-CoV Infection
• Covid19

Interventions

Type	Name	Description
OTHER	biobank	* 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

Timeline

• Start date: 2021-09-21
• Primary completion: 2023-06-18
• Completion: 2023-12-18
• First posted: 2021-05-13
• Last updated: 2025-05-28

Locations

37 sites across 1 country: France