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.
NCT ID: NCT04885452
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
756 participants
OBSERVATIONAL
2021-09-21
2023-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients treated with casirivimab/imdevimab according to the ATU protocol
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
Patients treated with bamlanivimab/etesevimab according to the ATU protocol
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
Patients treated with Xevudy according to the authorisation for early access (AAP) protocol
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
Patients treated with Paxlovid according to the authorisation for early access (AAP) protocol
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
Interventions
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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
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Inclusion Criteria
* Adults covered by the French social health coverage
* Adults who signed the informed consent form
Exclusion Criteria
* Vulnerable patient (adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty)
* Pregnant or breastfeeding woman
18 Years
ALL
No
Sponsors
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ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Youri Yordanov, Dr
Role: PRINCIPAL_INVESTIGATOR
Saint Antoine Hospital
Locations
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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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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ANRS0003S COCOPREV
Identifier Type: -
Identifier Source: org_study_id
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