Clinical trial NCT04863547: Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection
Official title: Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2021-04-28
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Acute symptomatic COVID PCR+ with screening Hospitalized for acute COVID between January 1,2021 (or since the implementation of the screening in the center) and february 28, 2021

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To estimate the proportion of Severe disease form
timeFrame: between the first day of hospitalization and Day 29
measure: To estimate the proportion of Mortality
timeFrame: Day 29
measure: To estimate the proportion of WHO score > 5
timeFrame: between the first day of hospitalization and Day 29
measure: To estimate the proportion of Patient who received critical care
timeFrame: between the first day of hospitalization and Day 29
measure: To estimate the proportion of patients who had invasive ventilation
timeFrame: between the first day of hospitalization and Day 29
measure: To estimate the proportion of patients who had high flow oxygen therapy
timeFrame: between the first day of hospitalization and Day 29
measure: Time between the first day of symptoms and the first day of hospitalization
timeFrame: between first day of symptoms and the first day of hospitalization assessed up to one month
measure: Delay between the first day of symptoms and the first day of hospitalization
timeFrame: between first day of symptoms and the first day of hospitalization assessed up to one month
measure: Time between the first day of symptoms and the severity of disease
timeFrame: between first day of symptoms and the severity assessed up to one month
measure: Time between the first day of symptoms and mortality
timeFrame: between first day of symptoms and mortality assessed up to two month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie Site Nord
city: Angers
country: France
facility: CHU Angers
city: Bobigny
country: France
facility: hôpital Avicenne
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Béziers
country: France
facility: Centre hospitalier de Béziers
city: Chambéry
country: France
facility: Centre hospitalier métropole Savoie
city: Châteaubriant
country: France
facility: Centre Hospitalier Châteaubriant Nozay Pouancé
city: Clichy
country: France
facility: Hôpital Beaujon
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes Léman
city: Corbeil-Essonnes
country: France
facility: Centre hopsitalier Sud Francilien
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal
city: Créteil
country: France
facility: Hôpital Henry Mondor
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Garches
country: France
facility: Hôpital de Garches
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Kremlin Bicêtre
city: Lille
country: France
facility: Hôpital SALENGRO
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Mantes-la-Jolie
country: France
facility: Centre Hospitalier François Quesnay
city: Montreuil
country: France
facility: Hôpital André Grégoire
city: Nantes
country: France
facility: Hopital Confluent
city: Nantes
country: France
facility: CHU Nantes
city: Neuilly-sur-Seine
country: France
facility: American Hospital of Paris
city: Nice
country: France
facility: Hôpital Archet
city: Noyal-Pontivy
country: France
facility: Centre Hospitalier du Centre-Bretagne
city: Nîmes
country: France
facility: Hôpital Carémeau
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Paris
country: France
facility: HôpitalSaint Antoine
city: Paris
country: France
facility: hôpital Cochin
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Saint Louis
city: Poissy
country: France
facility: CHI de Poissy/Saint-Germain-en-Laye
city: Périgueux
country: France
facility: Centre hospitalier de Perigueux
city: Reims
country: France
facility: CHU
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicoll
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Hôpital Purpan
city: Tourcoing
country: France
facility: Centre hospitalier de Tourcoing
city: Tours
country: France
facility: CHU Tours
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Valenciennes
country: France
facility: Centre hospitalier de Valenciennes
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy Brabois
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeneuve-Saint-Georges
country: France
facility: Centre Hospitalier Intercommunal
city: Fort-de-France
country: Martinique
facility: André Zobda Cabié
state: Martinique France
Study officials:
References: