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

April 27, 2021 updated by: ANRS, Emerging Infectious Diseases
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80000
        • Recruiting
        • CHU Amiens Picardie site Nord
        • Contact:
        • Principal Investigator:
          • Jean-luc Schmit, MD
        • Sub-Investigator:
          • Claire Andrejak, MD
      • Angers, France
        • Recruiting
        • Chu Angers
        • Contact:
        • Principal Investigator:
          • Vincent Dubee, MD
      • Bobigny, France, 93000
        • Recruiting
        • Hôpital Avicenne
        • Contact:
        • Principal Investigator:
          • Hugues Cordel, MD
      • Bordeaux, France, 33075
        • Recruiting
        • Hopital Pellegrin
        • Contact:
        • Contact:
          • Phone Number: +33556795679
        • Principal Investigator:
          • Duc Nguyen, MD
      • Boulogne-Billancourt, France, 92104
        • Recruiting
        • Hopital Ambroise Pare
        • Contact:
        • Principal Investigator:
          • Adeline BAUVOIS, MD
      • Béziers, France, 34 500
        • Recruiting
        • Centre Hospitalier de Beziers
        • Contact:
        • Principal Investigator:
          • Sophie DERIAZ, MD
      • Chambéry, France, 73011
        • Recruiting
        • Centre Hospitalier Metropole Savoie
        • Principal Investigator:
          • Emmanuel Forestier, MD
        • Contact:
      • Châteaubriant, France, 44 110
        • Recruiting
        • Centre Hospitalier Châteaubriant Nozay Pouancé
        • Contact:
        • Principal Investigator:
          • Pascal GICQUEL, MD
      • Clichy, France, 92110
        • Recruiting
        • Hôpital Beaujon
        • Contact:
        • Principal Investigator:
          • Victoire Dor De Lastours, MD
        • Sub-Investigator:
          • Agnès Lefort, MD
      • Colmar, France, 68000
        • Recruiting
        • Hôpitaux Civils de Colmar
        • Contact:
        • Principal Investigator:
          • Martin Martineau, MD
      • Contamine-sur-Arve, France, 74130
        • Recruiting
        • Centre hospitalier Alpes Léman
        • Contact:
          • Tomasz CHROBOCZEK, MD
        • Principal Investigator:
          • Tomasz CHROBOCZEK, MD
      • Corbeil-Essonnes, France, 91106
        • Recruiting
        • Centre hopsitalier Sud Francilien
        • Contact:
        • Principal Investigator:
          • Amélie Chabrol, MD
      • Creteil, France, 94 000
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Principal Investigator:
          • Valérie Garrait
        • Contact:
          • Valérie GARRAIT, MD
          • Phone Number: +33145175000
        • Sub-Investigator:
          • Claudine TOUBOUL
      • Créteil, France, 94000
        • Recruiting
        • Hôpital Henry Mondor
        • Contact:
        • Principal Investigator:
          • William Vindrios, MD
      • Dijon, France, 21079
        • Recruiting
        • CHU Dijon Bourgogne
        • Contact:
        • Principal Investigator:
          • Lionel D Piroth, MD
      • Garches, France, 92380
        • Recruiting
        • Hôpital de Garches
        • Contact:
        • Principal Investigator:
          • Aurélien Dihn, MD
        • Sub-Investigator:
          • Benjamin Davido, MD
      • Le Kremlin-Bicêtre, France, 94270
        • Not yet recruiting
        • Hôpital Kremlin Bicêtre
        • Contact:
        • Principal Investigator:
          • Simon Bessis, MD
        • Sub-Investigator:
          • Benjamin Wilpoz, MD
      • Lille, France, 59000
        • Recruiting
        • Hôpital Salengro
        • Contact:
        • Principal Investigator:
          • Julien POISSY, MD
      • Limoges, France, 87100
        • Recruiting
        • CHU Limoges
        • Contact:
        • Principal Investigator:
          • Jean-François Faucher, MD
      • Lyon, France, 69004
        • Recruiting
        • Hospices civils de Lyon
        • Contact:
        • Principal Investigator:
          • Thomas Perpoint, MD
      • Mantes-la-Jolie, France, 78200
        • Recruiting
        • Centre Hospitalier François Quesnay
        • Contact:
        • Principal Investigator:
          • Christophe Billy, MD
      • Montreuil, France, 93100
        • Recruiting
        • Hôpital André Grégoire
        • Contact:
        • Principal Investigator:
          • Guillemette FREMONT, MD
      • Nantes, France
        • Recruiting
        • Chu Nantes
        • Contact:
        • Principal Investigator:
          • François Raffi, MD
        • Sub-Investigator:
          • Paul Le Turnier, MD
      • Nantes, France, 44 000
        • Recruiting
        • Hopital Confluent
        • Contact:
        • Principal Investigator:
          • Olivier GROSSI, MD
      • Neuilly-sur-Seine, France, 92 200
        • Recruiting
        • American Hospital of Paris
        • Contact:
        • Principal Investigator:
          • Christophe RAPP, MD
      • Nice, France
        • Recruiting
        • Hôpital Archet
        • Contact:
        • Principal Investigator:
          • Véronique Mondain, MD
      • Noyal-Pontivy, France, 56920
        • Recruiting
        • Centre Hospitalier du Centre-Bretagne
        • Contact:
        • Principal Investigator:
          • Laurent BELLEC, MD
      • Nîmes, France, 30029
        • Recruiting
        • Hopital Caremeau
        • Principal Investigator:
          • Didier LAUREILLARD, MD
        • Contact:
      • Paris, France, 75014
        • Not yet recruiting
        • Hôpital Cochin
        • Contact:
        • Principal Investigator:
          • Luc Mouthon, MD
      • Paris, France, 75015
        • Recruiting
        • Hopital Necker
        • Contact:
        • Principal Investigator:
          • Fanny Lanternier, MD
      • Paris, France, 75475
        • Recruiting
        • Hopital Saint Louis
        • Contact:
        • Sub-Investigator:
          • Diane Ponscarme, MD
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon
        • Contact:
      • Paris, France, 75 012
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint-Simon
        • Contact:
        • Principal Investigator:
          • Delphine FEYEUX, MD
      • Paris, France, 75012
        • Recruiting
        • HôpitalSaint Antoine
        • Contact:
        • Principal Investigator:
          • Jérome Pacanowski, MD
      • Paris, France, 75019
        • Recruiting
        • Hôpital Bichat
        • Contact:
        • Principal Investigator:
          • Xavier Lescure, Pr
        • Sub-Investigator:
          • Nathan Peiffer-Smadja, MD
      • Poissy, France, 78300
        • Not yet recruiting
        • CHI de Poissy/Saint-Germain-en-Laye
        • Contact:
        • Principal Investigator:
          • Yves Welker, MD
      • Périgueux, France, 24 019
      • Reims, France, 51092
        • Not yet recruiting
        • CHU
        • Contact:
        • Principal Investigator:
          • Firouze Banisadr, MD
      • Rennes, France, 35033
        • Recruiting
        • Hôpital Pontchaillou
        • Contact:
        • Principal Investigator:
          • Jean-Marc Chapplain, MD
        • Sub-Investigator:
          • Pierre Tattevin, MD
      • Rouen, France, 76038
        • Recruiting
        • Hôpital Charles Nicoll
        • Contact:
        • Principal Investigator:
          • Kevin Alexandre, MD
      • Saint-Mandé, France, 94160
        • Not yet recruiting
        • Hôpital d'Instruction des Armées BEGIN
        • Contact:
        • Principal Investigator:
          • Cécile Ficko, MD
      • Strasbourg, France, 67000
      • Suresnes, France, 92150
        • Recruiting
        • Hopital FOCH
        • Contact:
        • Principal Investigator:
          • Philippe Lesprit, MD
      • Toulouse, France, 31300
        • Recruiting
        • Hopital Purpan
        • Contact:
        • Principal Investigator:
          • Guillame Martin-Blondel, MD
      • Tourcoing, France, 59200
        • Recruiting
        • Centre Hospitalier de Tourcoing
        • Contact:
        • Principal Investigator:
          • Olivier Robineau, MD
      • Tours, France
        • Recruiting
        • CHU Tours
        • Principal Investigator:
          • Louis Bernard, MD
        • Contact:
      • Valence, France, 26 000
        • Recruiting
        • Centre Hospitalier de Valence
        • Contact:
        • Principal Investigator:
          • Julien SAISON, MD
        • Sub-Investigator:
          • Amélie DUREAULT, MD
      • Valenciennes, France, 59 300
        • Recruiting
        • Centre hospitalier de valenciennes
        • Contact:
        • Principal Investigator:
          • Nicolas KADER ETTAHAR, MD
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • CHRU Nancy Brabois
        • Contact:
        • Principal Investigator:
          • François Goehringer, MD
      • Vannes, France, 56 000
        • Recruiting
        • Centre Hospitalier Bretagne Atlantique
        • Contact:
        • Principal Investigator:
          • Marie GOUSSEFF, MD
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
        • Principal Investigator:
          • Fanny POMMERET, MD
        • Sub-Investigator:
          • Merad MANSOURIA, MD
      • Villeneuve-Saint-Georges, France, 94190
        • Recruiting
        • Centre Hospitalier Intercommunal
        • Contact:
        • Principal Investigator:
          • Pauline Carreaux Paz, MD
  • Martinique
    • Martinique France
      • Fort-de-France, Martinique France, Martinique, 97200
        • Recruiting
        • André Zobda Cabié
        • Principal Investigator:
          • André CABIE, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed
Patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1
Other: Data collection
Data collection
Non exposed
Patients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2
Other: Data collection
Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the proportion of Severe disease form
Time Frame: 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.
between the first day of hospitalization and Day 29
To estimate the proportion of Mortality
Time Frame: Day 29
Percentage of mortality
Day 29
To estimate the proportion of WHO score > 5
Time Frame: between the first day of hospitalization and Day 29
Percentage of WHO score > 5
between the first day of hospitalization and Day 29
To estimate the proportion of Patient who received critical care
Time Frame: between the first day of hospitalization and Day 29
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
Time Frame: between the first day of hospitalization and Day 29
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
Time Frame: between the first day of hospitalization and Day 29
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 Frame: 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
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 Frame: 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
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 Frame: 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
between first day of symptoms and the severity assessed up to one month
Time between the first day of symptoms and mortality
Time Frame: between first day of symptoms and mortality assessed up to two month
Time between the first day of symptoms and mortality
between first day of symptoms and mortality assessed up to two month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 0007S SEVASAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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