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

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

— SEVASAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863547
• Other study ID #: ANRS 0007S SEVASAR
• Status: Recruiting
• Start date: March 11, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: Xavier Lescure, Pr
• Phone: 0140258080
• Email: xavier.lescure[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Data collection
Data collection

Locations

Country	Name	City	State
France	CHU Amiens Picardie Site Nord	Amiens
France	CHU Angers	Angers
France	Centre hospitalier de Béziers	Béziers
France	hôpital Avicenne	Bobigny
France	Hôpital Pellegrin	Bordeaux
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	Centre hospitalier métropole Savoie	Chambéry
France	Centre Hospitalier Châteaubriant Nozay Pouancé	Châteaubriant
France	Hôpital Beaujon	Clichy
France	Hôpitaux Civils de Colmar	Colmar
France	Centre Hospitalier Alpes Léman	Contamine-sur-Arve
France	Centre hopsitalier Sud Francilien	Corbeil-Essonnes
France	Centre Hospitalier Intercommunal	Creteil
France	Hôpital Henry Mondor	Créteil
France	CHU Dijon Bourgogne	Dijon
France	Hôpital de Garches	Garches
France	Hôpital Kremlin Bicêtre	Le Kremlin-Bicêtre
France	Hôpital SALENGRO	Lille
France	CHU Limoges	Limoges
France	Hospices Civils de Lyon	Lyon
France	Centre Hospitalier François Quesnay	Mantes-la-Jolie
France	Hôpital André Grégoire	Montreuil
France	CHU Nantes	Nantes
France	Hopital Confluent	Nantes
France	American Hospital of Paris	Neuilly-sur-Seine
France	Hôpital Archet	Nice
France	Hôpital Carémeau	Nîmes
France	Centre Hospitalier du Centre-Bretagne	Noyal-Pontivy
France	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris
France	Hôpital Bichat	Paris
France	hôpital Cochin	Paris
France	Hôpital Necker	Paris
France	Hôpital Saint Louis	Paris
France	Hôpital Tenon	Paris
France	HôpitalSaint Antoine	Paris
France	Centre hospitalier de Perigueux	Périgueux
France	CHI de Poissy/Saint-Germain-en-Laye	Poissy
France	CHU	Reims
France	Hôpital Pontchaillou	Rennes
France	Hôpital Charles Nicoll	Rouen
France	Hôpital d'Instruction des Armées Bégin	Saint-Mandé
France	Nouvel Hopital Civil	Strasbourg
France	Hôpital Foch	Suresnes
France	Hôpital Purpan	Toulouse
France	Centre hospitalier de Tourcoing	Tourcoing
France	CHU Tours	Tours
France	Centre Hospitalier de Valence	Valence
France	Centre hospitalier de Valenciennes	Valenciennes
France	CHRU Nancy Brabois	Vandœuvre-lès-Nancy
France	Centre Hospitalier Bretagne Atlantique	Vannes
France	Institut Gustave Roussy	Villejuif
France	Centre Hospitalier Intercommunal	Villeneuve-Saint-Georges
Martinique	André Zobda Cabié	Fort-de-France	Martinique France

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To estimate the proportion of Mortality	Percentage of mortality	Day 29
Primary	To estimate the proportion of WHO score > 5	Percentage of WHO score > 5	between the first day of hospitalization and Day 29
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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