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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.

NCT04885452 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 756

Last updated 2025-05-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Youri Yordanov, Dr · Saint Antoine Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2023-06-18
Completion
2023-12-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885452 on ClinicalTrials.gov