Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection
SEVASAR
1 other identifier
observational
2,200
2 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Shorter than P25 for all trials
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2021
CompletedFirst Submitted
Initial submission to the registry
April 8, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedApril 28, 2021
April 1, 2021
2 months
April 8, 2021
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (10)
To estimate the proportion of Severe disease form
Percentage of severe form. Severity was defined by a composite criterion including, at Day 28 days from hospital admission: WHO scale \>5 /11 levels, (death OR required invasive ventilation OR required high flow ventilation (Optiflex or NIV or CPAP) or high concentration mask.
between the first day of hospitalization and Day 29
To estimate the proportion of Mortality
Percentage of mortality
Day 29
To estimate the proportion of WHO score > 5
Percentage of WHO score \> 5
between the first day of hospitalization and Day 29
To estimate the proportion of Patient who received critical care
Percentage of patients who received critical care
between the first day of hospitalization and Day 29
To estimate the proportion of patients who had invasive ventilation
Percentage of patients who had invasive ventilation
between the first day of hospitalization and Day 29
To estimate the proportion of patients who had high flow oxygen therapy
Percentage of patients who had high flow oxygen therapy
between the first day of hospitalization and Day 29
Time between the first day of symptoms and the first day of hospitalization
Time between the first day of symptoms and the first day of hospitalization
between first day of symptoms and the first day of hospitalization assessed up to one month
Delay between the first day of symptoms and the first day of hospitalization
Time between the first day of symptoms and the first day of hospitalization
between first day of symptoms and the first day of hospitalization assessed up to one month
Time between the first day of symptoms and the severity of disease
Time between the first day of symptoms and the severity of disease
between first day of symptoms and the severity assessed up to one month
Time between the first day of symptoms and mortality
Time between the first day of symptoms and mortality
between first day of symptoms and mortality assessed up to two month
Study Arms (2)
Exposed
Patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1
Non exposed
Patients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Opposition to participation
- Identification of variants other than 20I / 501Y.V1
- Patients infected with SARS-CoV-2 in a nosocomial context
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
CHU Amiens Picardie Site Nord
Amiens, 80000, France
CHU Angers
Angers, France
Centre hospitalier de Béziers
Béziers, 34 500, France
hôpital Avicenne
Bobigny, 93000, France
Hôpital Pellegrin
Bordeaux, 33075, France
Hôpital Ambroise Paré
Boulogne-Billancourt, 92104, France
Centre hospitalier métropole Savoie
Chambéry, 73011, France
Centre Hospitalier Châteaubriant Nozay Pouancé
Châteaubriant, 44 110, France
Hôpital Beaujon
Clichy, 92110, France
Hôpitaux Civils de Colmar
Colmar, 68000, France
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, 74130, France
Centre hopsitalier Sud Francilien
Corbeil-Essonnes, 91106, France
Centre Hospitalier Intercommunal
Créteil, 94 000, France
Hôpital Henry Mondor
Créteil, 94000, France
CHU Dijon Bourgogne
Dijon, 21079, France
Hôpital de Garches
Garches, 92380, France
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270, France
Hôpital SALENGRO
Lille, 59000, France
CHU Limoges
Limoges, 87100, France
Hospices Civils de Lyon
Lyon, 69004, France
Centre Hospitalier François Quesnay
Mantes-la-Jolie, 78200, France
Hôpital André Grégoire
Montreuil, 93100, France
Hopital Confluent
Nantes, 44 000, France
CHU Nantes
Nantes, France
American Hospital of Paris
Neuilly-sur-Seine, 92 200, France
Hôpital Archet
Nice, France
Hôpital Carémeau
Nîmes, 30029, France
Centre Hospitalier du Centre-Bretagne
Noyal-Pontivy, 56920, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75 012, France
HôpitalSaint Antoine
Paris, 75012, France
hôpital Cochin
Paris, 75014, France
Hôpital Necker
Paris, 75015, France
Hôpital Bichat
Paris, 75019, France
Hôpital Tenon
Paris, 75020, France
Hôpital Saint Louis
Paris, 75475, France
Centre hospitalier de Perigueux
Périgueux, 24 019, France
CHI de Poissy/Saint-Germain-en-Laye
Poissy, 78300, France
CHU
Reims, 51092, France
Hôpital Pontchaillou
Rennes, 35033, France
Hôpital Charles Nicoll
Rouen, 76038, France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160, France
Nouvel Hopital Civil
Strasbourg, 67000, France
Hôpital Foch
Suresnes, 92150, France
Hôpital Purpan
Toulouse, 31300, France
Centre hospitalier de Tourcoing
Tourcoing, 59200, France
CHU Tours
Tours, France
Centre Hospitalier de Valence
Valence, 26 000, France
Centre hospitalier de Valenciennes
Valenciennes, 59 300, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Centre Hospitalier Bretagne Atlantique
Vannes, 56 000, France
Institut Gustave Roussy
Villejuif, 94805, France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, 94190, France
André Zobda Cabié
Fort-de-France, Martinique France, 97200, Martinique
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2021
First Posted
April 28, 2021
Study Start
March 11, 2021
Primary Completion
April 30, 2021
Study Completion
May 31, 2021
Last Updated
April 28, 2021
Record last verified: 2021-04