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 | Completed

• 1 other identifier: ANRS0003S COCOPREV
• Study Type: observational
• Target: 756
• Locations: 1 country
• Sites: 37

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).

Conditions

SARS-CoV Infection; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Percentage of patients hospitalized whatever the reason

  Month 1 and 3

• Percentage of patients with an WHO score >= 5

  Month 1

• Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset

  Month 1

• Percentage of patients who died from COVID-19 complications and any other reason

  Month 1

• Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events

  Month 1

Study Arms (4)

Patients treated with casirivimab/imdevimab according to the ATU protocol

Other: biobank

Patients treated with bamlanivimab/etesevimab according to the ATU protocol

Other: biobank

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

Other: biobank

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

Other: biobank

Interventions

biobank OTHER

* 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

Patients treated with Paxlovid according to the authorisation for early access (AAP) protocol; Patients treated with Xevudy according to the authorisation for early access (AAP) protocol; Patients treated with bamlanivimab/etesevimab according to the ATU protocol; Patients treated with casirivimab/imdevimab according to the ATU protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients infected with SARS-CoV-2 referred by their doctor (general practitioner, specialist, SOS doctor, etc.) to a prescribing center authorized to prescribe and deliver treatments benefiting from an ATU/AAP.

You may qualify if:

• 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

You may not qualify if:

• Vulnerable patient (adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty)
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (37)

CH Agen-Nerac

Agen, France

Location

CHU d'Angers

Angers, France

Location

CHR Metz-Thionville

Ars-Laquenexy, France

Location

Hôpital Avicenne

Bobigny, France

Location

CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, France

Location

Centre Hospitalier Sud Francilien - Hématologie

Corbeil-Essonnes, 91106, France

Location

Centre Hospitalier Sud Francilien - Néphrologie

Corbeil-Essonnes, 91106, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Martinique

Fort-de-France, 97261, France

Location

Hôpital Bicêtre - Médecine interne

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Bicêtre - SMIT

Le Kremlin-Bicêtre, 94275, France

Location

CHU de Limoges

Limoges, France

Location

Hospices Civils de Lyon (HCL)

Lyon, France

Location

CHU de Montpellier

Montpellier, France

Location

CHRU de Nancy

Nancy, 54511, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nîmes

Nîmes, France

Location

Hôpital Lariboisière - SMIT

Paris, 75010, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Hôpital Bichat Claude-Bernard

Paris, 75018, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Hôpital Bichat Claude-Bernard - SAU

Paris, France

Location

Hôpital Lariboisière - SAU SMUR

Paris, France

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

Hôpital Saint Antoine - SAU

Paris, France

Location

Hôpital Saint-Louis

Paris, France

Location

Hôpital Universitaire Necker Enfants Malades

Paris, France

Location

Hôpitaux Cochin - Port Royal

Paris, France

Location

CHI Poissy St Germain en Laye

Poissy, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rennes

Rennes, France

Location

CH de Tarbes

Tarbes, France

Location

CHU de Toulouse - IUCT - Oncopole

Toulouse, France

Location

CHU de Toulouse

Toulouse, France

Location

CH de Tourcoing

Tourcoing, France

Location

CHRU de Tours - Hôpital Bretonneau

Tours, France

Location

Related Publications (4)

• Bruel T, Vrignaud LL, Porrot F, Staropoli I, Planas D, Guivel-Benhassine F, Puech J, Prot M, Munier S, Henry-Bolland W, Soulie C, Zafilaza K, Lusivika-Nzinga C, Meledge ML, Dorival C, Molino D, Pere H, Yordanov Y, Simon-Loriere E, Veyer D, Carrat F, Schwartz O, Marcelin AG, Martin-Blondel G; ANRS 0003S CoCoPrev Study Group. Antiviral activities of sotrovimab against BQ.1.1 and XBB.1.5 in sera of treated patients. medRxiv [Preprint]. 2023 May 30:2023.05.25.23290512. doi: 10.1101/2023.05.25.23290512.

  PMID: 37398037 BACKGROUND

• Bruel T, Vrignaud LL, Porrot F, Staropoli I, Planas D, Guivel-Benhassine F, Puech J, Prot M, Munier S, Bolland WH, Soulie C, Zafilaza K, Lusivika-Nzinga C, Meledge ML, Dorival C, Molino D, Pere H, Yordanov Y, Simon-Loriere E, Veyer D, Carrat F, Schwartz O, Marcelin AG, Martin-Blondel G; ANRS 0003S CoCoPrev Study Group. Sotrovimab therapy elicits antiviral activities against Omicron BQ.1.1 and XBB.1.5 in sera of immunocompromised patients. Med. 2023 Oct 13;4(10):664-667. doi: 10.1016/j.medj.2023.07.007.

  PMID: 37837962 BACKGROUND

• Martin-Blondel G, Marcelin AG, Soulie C, Kaisaridi S, Lusivika-Nzinga C, Zafilaza K, Dorival C, Nailler L, Boston A, Ronchetti AM, Melenotte C, Cabie A, Choquet C, Trinh-Duc A, Lacombe K, Gaube G, Coustilleres F, Pourcher V, Martellosio JP, Peiffer-Smadja N, Chauveau M, Housset P, Piroth L, Devaux M, Pialoux G, Martin A, Dubee V, Frey J, Le Bot A, Cazanave C, Petua P, Liblau R, Carrat F, Yordanov Y. Time to negative PCR conversion amongst high-risk patients with mild-to-moderate Omicron BA.1 and BA.2 COVID-19 treated with sotrovimab or nirmatrelvir. Clin Microbiol Infect. 2023 Apr;29(4):543.e5-543.e9. doi: 10.1016/j.cmi.2022.12.016. Epub 2022 Dec 28.

  PMID: 36586513 BACKGROUND

• Martin-Blondel G, Marcelin AG, Soulie C, Kaisaridi S, Lusivika-Nzinga C, Dorival C, Nailler L, Boston A, Melenotte C, Gaube G, Choquet C, Liblau R, Carrat F, Yordanov Y; COCOPREV Study Group. Outcome of very high-risk patients treated by Sotrovimab for mild-to-moderate COVID-19 Omicron, a prospective cohort study (the ANRS 0003S COCOPREV study). J Infect. 2022 Jun;84(6):e101-e104. doi: 10.1016/j.jinf.2022.04.010. Epub 2022 Apr 7. No abstract available.

  PMID: 35398409 BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Interventions

Biological Specimen Banks

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Youri Yordanov, Dr

  Saint Antoine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 13, 2021
• Study Start: September 21, 2021
• Primary Completion: June 18, 2023
• Study Completion: December 18, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (37)