Official Title
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.
Brief Summary

This is a prospective, multicentric, non comparative study aiming to evaluate theclinical and virological evolution of high-risk patients infected with SARS-CoV-2 treatedwithtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') orauthorisation for early access (AAP) delivered by the French drug agency (ANSM).

Detailed Description

Not Provided

Unknown status
SARS-CoV Infection
COVID19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

CH Agen-Nerac
Agen, France

CHU d'Angers
Angers, France

CHR Metz-Thionville
Ars-Laquenexy, France

Hôpital Avicenne
Bobigny, France

CHU de Bordeaux
Bordeaux, France

CHU Gabriel Montpied
Clermont-Ferrand, 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 - Médecine interne
Le Kremlin-Bicêtre, 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

CHRU de Nancy
Nancy, France

CHU de Nantes
Nantes, France

CHU de Nîmes
Nîmes, France

Hôpital Lariboisière - SMIT
Paris, France

Hôpital Saint Antoine
Paris, France

Hôpital Bichat Claude-Bernard
Paris, France

Hôpital Tenon
Paris, France

Hôpital Bichat Claude-Bernard - SAU
Paris, France

Hôpital Lariboisière - SAU SMUR
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

Hôpitaux Cochin - Port Royal
Paris, France

CHI Poissy St Germain en Laye
Poissy, France

CHU de Poitiers
Poitiers, 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

Contacts

Youri Yordanov, Dr
01 71 97 08 69
youri.yordanov@aphp.fr

Guillaume Martin-Blondel, Pr
05 61 77 96 99
martin-blondel.g@chu-toulouse.fr

Youri Yordanov, Dr, Principal Investigator
Saint Antoine Hospital

ANRS, Emerging Infectious Diseases
NCT Number
MeSH Terms
COVID-19
Severe Acute Respiratory Syndrome