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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with casirivimab/imdevimab according to the ATU protocol |
| ||
| Patients treated with bamlanivimab/etesevimab according to the ATU protocol |
| ||
| Patients treated with Xevudy according to the authorisation for early access (AAP) protocol |
| ||
| Patients treated with Paxlovid according to the authorisation for early access (AAP) protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biobank | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Youri Yordanov, Dr | Saint Antoine Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Agen-Nerac | Agen | France | ||||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37398037 | Background | 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. | |
| 37837962 |
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|
| 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 |
| Time between first symptoms and treatment and the reasons for this delay | Day 0 |
| Virological response | Percentage of virological response defined by CT>=31 or negative PCR test + | Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients |
| Virological criteria linked to the emergence of resistance | Percentage of patients included developing resistance variants, genotypic and phenotypic characterization of resistance variants | from inclusion until a negative PCR test or Ct ≥31 is obtained |
| Percentage of patients with positive anti-N and anti-S serology | Day 0 and Month 3 |
| anti-S antibody level | Day 0 and Month 3 |
| Flow cytometry cartography of myeloid response | Flow cytometry cartography of myeloid (functional subtypes of monocytes and dendritic cells) response | Day 0, 7 and Month 1 |
| Flow cytometry cartography of T-lymphocyte response | Flow cytometry cartography of T-lymphocyte (conventional T-lymphocytes by identifying naïve, memory and effector Th1, Th2, Tfh and Th17 T-lymphocytes, NK and gamma-delta T-lymphocytes, regulatory T-lymphocytes; surface and intracellular markers) response | Day 0, 7 and Month 1 |
| Flow cytometry cartography of B-lymphocyte response | Flow cytometry cartography of B-lymphocyte (transitional, naïve, memory T-lymphocyte with or without isotypic switching, plasmablasts) response | Day 0, 7 and Month 1 |
| Dosing of a wide range of cytokines and chemokines (IFNalpha, IFNgamma, IL-6, IL-1, IL-8, IL-15, IL-18, IL1-RA, IL-7, IL-10, CXCL10, CXCL13, CCL2 and CCL3) using the Meso Scale Discovery approach | Day 0, 7 and Month 1 |
| Clinical and biological predictors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants) of the onset of complications from COVID19, hospitalization, death | Identication of clinical and biological predictors of the onset of complications from COVID19, hospitalization, death by a logistic model or survival model (RMST): the response variable is the occurrence of a complication, hospitalization, death or the average survival at 1 month on these different criteria; the covariates are the parameters at inclusion, the treatment received, the virological criteria (CT, variants) which can be considered as a time-dependent covariate | from inclusion until the end of the follow-up (Month 1 or Month 3) |
| Clinical and biological predictive factors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants)) linked to the neutralizing serological response: non-response, duration of the response | Identification of clinical and biological predictive factors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants)) linked to the neutralizing serological response: non-response, duration of the response by a logistic model or mixed model for repeated measures | from inclusion until the end of the follow-up (Month 1 or Month 3) |
| Clinical and biological predictors (clinical parameters, treatment received, virological criteria) of viral response (viral genotypes, emergence of resistant strains) | Identification of clinical and biological predictive factors related to the virological response (viral genotypes, emergence of resistant strains) by a logistic model: the response variable is RT-PCR negativation at D7 (or CT≥31), the covariates are the parameters at inclusion, the treatment received, the virological criteria at baseline | from inclusion until the end of the follow-up (Month 1 or Month 3) |
| Angers |
| France |
| CHR Metz-Thionville | Ars-Laquenexy | France |
| Hôpital Avicenne | Bobigny | France |
| CHU de Bordeaux | Bordeaux | 33076 | France |
| CHU Gabriel Montpied | Clermont-Ferrand | France |
| Centre Hospitalier Sud Francilien - Hématologie | Corbeil-Essonnes | 91106 | France |
| Centre Hospitalier Sud Francilien - Néphrologie | Corbeil-Essonnes | 91106 | France |
| CHU de Dijon | Dijon | France |
| CHU de Martinique | Fort-de-France | 97261 | France |
| Hôpital Bicêtre - Médecine interne | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Bicêtre - SMIT | Le Kremlin-Bicêtre | 94275 | France |
| CHU de Limoges | Limoges | France |
| Hospices Civils de Lyon (HCL) | Lyon | France |
| CHU de Montpellier | Montpellier | France |
| CHRU de Nancy | Nancy | 54511 | France |
| CHU de Nantes | Nantes | France |
| CHU de Nîmes | Nîmes | France |
| Hôpital Lariboisière - SMIT | Paris | 75010 | France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| Hôpital Bichat Claude-Bernard | Paris | 75018 | France |
| Hôpital Tenon | Paris | 75020 | 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 |
| 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. |
| 36586513 | 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. |
| 35398409 | 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. |
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D018070 | Biological Specimen Banks |
| ID | Term |
|---|---|
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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