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Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection

NCT ID: NCT04863547

Last Updated: 2021-04-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-11

Study Completion Date

2021-05-31

Brief Summary

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The COVID-19 epidemic has now raged for more than a year with more than 100 million identified cases and nearly 2.5 million deaths worldwide. Since November 2020, we have been witnessing the emergence of viral variants in different regions of the world. This expected genetic drift of the virus, but somewhat abrupt since November, raises questions concerning the characteristics of transmissibility, pathogenicity, sensitivity to possible treatments, and escape from natural or vaccine immunity. The objective of this study is to find out whether the new variants of SARS-CoV-2 are associated with particular clinical forms. The results of this research will provide elements to determine whether the new variants of SARS-CoV-2 are associated with more severe clinical forms.

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Detailed Description

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SEVASAR is a paired cohort study with retrospective data collection:

* Presentation: patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1
* Not exposed: patients hospitalized for COVID-19 with SARS-CoV-2 corresponding to wild variants type 20A. EU1 or 20A. EU2

The severity of illness will be compared between pairs. Disease severity will be assessed according to the following definition: defined by a composite criterion including, at 28 days after hospital admission: WHO scale \>5 /11 levels, (death OR need for invasive ventilation OR need for high flow ventilation (Optiflex or NIV or CPAP) or high concentration mask. This event will be taken into account regardless of its time of occurrence between the first day of the hospitalization studied and D29 after hospital admission.

Conditions

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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Exposed

Patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1

Data collection

Intervention Type OTHER

Data collection

Non exposed

Patients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2

Data collection

Intervention Type OTHER

Data collection

Interventions

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Data collection

Data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult
* Acute symptomatic PCR + COVID with screening
* Hospitalized for acute COVID between 01/01/2021 (or since the setting up of the screening in the center) and 02/28/2021

Exclusion Criteria

* Opposition to participation
* Identification of variants other than 20I / 501Y.V1
* Patients infected with SARS-CoV-2 in a nosocomial context
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie Site Nord

Amiens, , France

Site Status RECRUITING

CHU Angers

Angers, , France

Site Status RECRUITING

Centre hospitalier de Béziers

Béziers, , France

Site Status RECRUITING

hôpital Avicenne

Bobigny, , France

Site Status RECRUITING

Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Site Status RECRUITING

Centre hospitalier métropole Savoie

Chambéry, , France

Site Status RECRUITING

Centre Hospitalier Châteaubriant Nozay Pouancé

Châteaubriant, , France

Site Status RECRUITING

Hôpital Beaujon

Clichy, , France

Site Status RECRUITING

Hôpitaux Civils de Colmar

Colmar, , France

Site Status RECRUITING

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, , France

Site Status RECRUITING

Centre hopsitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

Centre Hospitalier Intercommunal

Créteil, , France

Site Status RECRUITING

Hôpital Henry Mondor

Créteil, , France

Site Status RECRUITING

CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Hôpital de Garches

Garches, , France

Site Status RECRUITING

Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status NOT_YET_RECRUITING

Hôpital SALENGRO

Lille, , France

Site Status RECRUITING

CHU Limoges

Limoges, , France

Site Status RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Centre Hospitalier François Quesnay

Mantes-la-Jolie, , France

Site Status RECRUITING

Hôpital André Grégoire

Montreuil, , France

Site Status RECRUITING

Hopital Confluent

Nantes, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status RECRUITING

American Hospital of Paris

Neuilly-sur-Seine, , France

Site Status RECRUITING

Hôpital Archet

Nice, , France

Site Status RECRUITING

Hôpital Carémeau

Nîmes, , France

Site Status RECRUITING

Centre Hospitalier du Centre-Bretagne

Noyal-Pontivy, , France

Site Status RECRUITING

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, , France

Site Status RECRUITING

HôpitalSaint Antoine

Paris, , France

Site Status RECRUITING

hôpital Cochin

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Necker

Paris, , France

Site Status RECRUITING

Hôpital Bichat

Paris, , France

Site Status RECRUITING

Hôpital Tenon

Paris, , France

Site Status RECRUITING

Hôpital Saint Louis

Paris, , France

Site Status RECRUITING

Centre hospitalier de Perigueux

Périgueux, , France

Site Status RECRUITING

CHI de Poissy/Saint-Germain-en-Laye

Poissy, , France

Site Status NOT_YET_RECRUITING

CHU

Reims, , France

Site Status NOT_YET_RECRUITING

Hôpital Pontchaillou

Rennes, , France

Site Status RECRUITING

Hôpital Charles Nicoll

Rouen, , France

Site Status RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, , France

Site Status NOT_YET_RECRUITING

Nouvel Hopital Civil

Strasbourg, , France

Site Status RECRUITING

Hôpital Foch

Suresnes, , France

Site Status RECRUITING

Hôpital Purpan

Toulouse, , France

Site Status RECRUITING

Centre hospitalier de Tourcoing

Tourcoing, , France

Site Status RECRUITING

CHU Tours

Tours, , France

Site Status RECRUITING

Centre Hospitalier de Valence

Valence, , France

Site Status RECRUITING

Centre hospitalier de Valenciennes

Valenciennes, , France

Site Status RECRUITING

CHRU Nancy Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Centre Hospitalier Bretagne Atlantique

Vannes, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Centre Hospitalier Intercommunal

Villeneuve-Saint-Georges, , France

Site Status RECRUITING

André Zobda Cabié

Fort-de-France, Martinique France, Martinique

Site Status RECRUITING

Countries

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France Martinique

Central Contacts

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Xavier Lescure, Pr

Role: CONTACT

[email protected]
0140258080

Guillaume Martin-Blondel, Pr

Role: CONTACT

[email protected]
0561779699

Facility Contacts

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Jean-luc Schmit, MD

Role: primary

[email protected]
+33322668813

Vincent Dubee, MD

Role: primary

[email protected]
+33241353930

Sophie DERIAZ, MD

Role: primary

[email protected]

Hugues Cordel, MD

Role: primary

[email protected]
+33148955421

Duc Nguyen, MD

Role: primary

[email protected]

Role: backup

+33556795679

Adeline BAUVOIS, MD

Role: primary

[email protected]

Emmanuel FORESTIER, MD

Role: primary

[email protected]
+334 79 96 51 72

Pascal GICQUEL, MD

Role: primary

[email protected]
+332 40 55 88 88

Victoire Dor De Lastours, MD

Role: primary

[email protected]
+33171114620

Martin Martineau, MD

Role: primary

[email protected]
+33389124078

Tomasz CHROBOCZEK, MD

Role: primary

Amélie Chabrol, MD

Role: primary

[email protected]
+33161696615

Valérie GARRAIT, MD

Role: primary

+33145175000

William Vindrios, MD

Role: primary

[email protected]
+331145178109

Lionel Piroth, MD

Role: primary

[email protected]
+33380295475

Aurélien Dihn, MD

Role: primary

[email protected]
+33147107752

Simon BESSIS, MD

Role: primary

[email protected]
+33145217300

Julien POISSY, MD

Role: primary

[email protected]
+33 3 20 44 59 62

Jean-François Faucher, MD

Role: primary

[email protected]
+33555055555

Thomas Perpoint, MD

Role: primary

[email protected]
+33472071107

Christophe Billy, MD

Role: primary

[email protected]
+33134974000

Guillemette FREMONT, MD

Role: primary

[email protected]
+331 49 20 30 40

Olivier GROSSI, MD

Role: primary

[email protected]
+332 28 25 56 15

François Raffi, MD

Role: primary

[email protected]
+33240083112

Christophe RAPP, MD

Role: primary

[email protected]
+33146412728

Véronique Mondain, MD

Role: primary

[email protected]
+33492035452

Didier LAUREILLARD, MD

Role: primary

[email protected]
+33466684149

Laurent BELLEC, MD

Role: primary

[email protected]
+332 97 79 00 05

Delphine FEYEUX, MD

Role: primary

[email protected]

Jérôme Pacanowski, MD

Role: primary

[email protected]
+33149282438

Luc Mouthon, MD

Role: primary

[email protected]
+33158411436

Fanny Lanternier, MD

Role: primary

[email protected]
+33144381742

Xavier Lescure, Pr

Role: primary

[email protected]
+33140258080

Gilles Pialoux, MD

Role: primary

[email protected]
+33156017412

Jean-Michel Molina, MD

Role: primary

[email protected]
+33142494117

Jean-benoit ZABBE, MD

Role: primary

[email protected]

Yves WELKER, MD

Role: primary

[email protected]
+33139274125

Firouze Banisadr, MD

Role: primary

[email protected]
+33326787186

Jean-Marc Chapplain, MD

Role: primary

[email protected]
+33299284321

Kevin Alexandre, Dr

Role: primary

[email protected]
+33232888739

Cecile Ficko, MD

Role: primary

[email protected]
+33143985000

Nicolas Lefebvre, MD

Role: primary

[email protected]
+33388116768

Philippe Lesprit, MD

Role: primary

[email protected]
+33146252525

Guillame Martin-Blondel, MD

Role: primary

[email protected]
+33561779117

Olivier Robineau, MD

Role: primary

[email protected]
+33320694616

Louis Bernard, MD

Role: primary

[email protected]
+33247473714

Julien SAISON, MD

Role: primary

[email protected]

Nicolas KADER ETTAHAR, MD

Role: primary

[email protected]
+333 27 14 33 33

François Goehringer, MD

Role: primary

[email protected]
+33383154800

Marie GOUSSEFF, MD

Role: primary

[email protected]
+332 97 01 41 41

Fanny POMMERET, MD

Role: primary

[email protected]
+331 42 11 42 11

Pauline Carreaux Paz, MD

Role: primary

[email protected]
+33143862000

André Z Cabié, MD

Role: primary

[email protected]
+33596559673

Other Identifiers

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ANRS 0007S SEVASAR

Identifier Type: -

Identifier Source: org_study_id

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