Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Interventions
- Other: Data collection
- Registration Number
- NCT04863547
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2200
- 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
- Opposition to participation
- Identification of variants other than 20I / 501Y.V1
- Patients infected with SARS-CoV-2 in a nosocomial context
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed Data collection Patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1 Non exposed Data collection Patients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2
- Primary Outcome Measures
Name Time Method To estimate the proportion of WHO score > 5 between the first day of hospitalization and Day 29 Percentage of WHO score \> 5
To estimate the proportion of Patient who received critical care between the first day of hospitalization and Day 29 Percentage of patients who received critical care
To estimate the proportion of patients who had invasive ventilation between the first day of hospitalization and Day 29 Percentage of patients who had invasive ventilation
To estimate the proportion of patients who had high flow oxygen therapy between the first day of hospitalization and Day 29 Percentage of patients who had high flow oxygen therapy
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 first day of hospitalization
Delay 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 first day of hospitalization
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 the severity of disease
To estimate the proportion of Severe disease form between the first day of hospitalization and Day 29 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.
To estimate the proportion of Mortality Day 29 Percentage of mortality
Time between the first day of symptoms and mortality between first day of symptoms and mortality assessed up to two month Time between the first day of symptoms and mortality
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
CHU Amiens Picardie Site Nord
🇫🇷Amiens, France
hôpital Avicenne
🇫🇷Bobigny, France
Centre hospitalier métropole Savoie
🇫🇷Chambéry, France
CHU Angers
🇫🇷Angers, France
Hôpital Beaujon
🇫🇷Clichy, France
Centre hopsitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
Centre Hospitalier Intercommunal
🇫🇷Villeneuve-Saint-Georges, France
Centre Hospitalier Châteaubriant Nozay Pouancé
🇫🇷Châteaubriant, France
Hôpital Henry Mondor
🇫🇷Créteil, France
Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
Centre hospitalier de Béziers
🇫🇷Béziers, France
Hôpital de Garches
🇫🇷Garches, France
Hôpital Kremlin Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
CHU Nantes
🇫🇷Nantes, France
Hôpital Foch
🇫🇷Suresnes, France
Hospices Civils de Lyon
🇫🇷Lyon, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
🇫🇷Paris, France
Hôpital Bichat
🇫🇷Paris, France
CHI de Poissy/Saint-Germain-en-Laye
🇫🇷Poissy, France
Hôpital Purpan
🇫🇷Toulouse, France
Centre hospitalier de Perigueux
🇫🇷Périgueux, France
Hôpital d'Instruction des Armées Bégin
🇫🇷Saint-Mandé, France
Hôpital Pellegrin
🇫🇷Bordeaux, France
Hôpitaux Civils de Colmar
🇫🇷Colmar, France
Centre Hospitalier Alpes Léman
🇫🇷Contamine-sur-Arve, France
CHU Dijon Bourgogne
🇫🇷Dijon, France
Hôpital SALENGRO
🇫🇷Lille, France
CHU Limoges
🇫🇷Limoges, France
Centre Hospitalier François Quesnay
🇫🇷Mantes-la-Jolie, France
Hôpital André Grégoire
🇫🇷Montreuil, France
Hopital Confluent
🇫🇷Nantes, France
American Hospital of Paris
🇫🇷Neuilly-sur-Seine, France
Hôpital Archet
🇫🇷Nice, France
Centre Hospitalier du Centre-Bretagne
🇫🇷Noyal-Pontivy, France
Hôpital Carémeau
🇫🇷Nîmes, France
HôpitalSaint Antoine
🇫🇷Paris, France
hôpital Cochin
🇫🇷Paris, France
Hôpital Necker
🇫🇷Paris, France
Hôpital Tenon
🇫🇷Paris, France
Hôpital Saint Louis
🇫🇷Paris, France
CHU
🇫🇷Reims, France
Hôpital Pontchaillou
🇫🇷Rennes, France
Centre hospitalier de Tourcoing
🇫🇷Tourcoing, France
Hôpital Charles Nicoll
🇫🇷Rouen, France
Nouvel Hopital Civil
🇫🇷Strasbourg, France
CHU Tours
🇫🇷Tours, France
CHRU Nancy Brabois
🇫🇷Vandœuvre-lès-Nancy, France
Centre Hospitalier de Valence
🇫🇷Valence, France
Centre hospitalier de Valenciennes
🇫🇷Valenciennes, France
Centre Hospitalier Bretagne Atlantique
🇫🇷Vannes, France
André Zobda Cabié
🇲🇶Fort-de-France, Martinique France, Martinique
Institut Gustave Roussy
🇫🇷Villejuif, France