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.

Study Timeline

• Study Start: 2021-03-11
• Status Verified: 2021-04
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-28
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

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

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Exclusion Criteria

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

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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

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