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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)SEVASARNCT04863547

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

An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by ANRS, Emerging Infectious Diseases at 53 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Data collection
How many people
2,200 participants
Where
53 sitesin 2 countries
Study dates
11 Mar 2021to 31 May 2021
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

53 sites in 2 countries.

Xavier Lescure, Pr contact

0140258080

xavier.lescure@aphp.fr

Guillaume Martin-Blondel, Pr contact

0561779699

martin-blondel.g@chu-toulouse.fr

53 sites in 2 countries

France52 sites, 52 recruiting

  • CHU Amiens Picardie Site Nord

    Amiens, 80000

    Jean-luc Schmit, MD, +33322668813, Schmit.Jean-Luc@chu-amiens.fr

    Jean-luc Schmit, MD

    Recruiting

  • CHU Angers

    Angers

    Vincent Dubee, MD, +33241353930, vincent.dubee@chu-angers.fr

    Vincent Dubee, MD

    Recruiting

  • Centre hospitalier de Béziers

    Béziers, 34 500

    Sophie DERIAZ, MD, sophie.deriaz@hotmail.fr

    Sophie DERIAZ, MD

    Recruiting

  • hôpital Avicenne

    Bobigny, 93000

    Hugues Cordel, MD, +33148955421, hugues.cordel@aphp.fr

    Hugues Cordel, MD

    Recruiting

  • Hôpital Pellegrin

    Bordeaux, 33075

    Duc Nguyen, MD, duc.nguyen@chu-bordeaux.fr

    +33556795679

    Recruiting

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104

    Adeline BAUVOIS, MD, adeline.bauvois@aphp.fr

    Adeline BAUVOIS, MD

    Recruiting

  • Centre hospitalier métropole Savoie

    Chambéry, 73011

    Emmanuel FORESTIER, MD, +334 79 96 51 72, emmanuel.forestier@ch-metropole-savoie.fr

    Emmanuel FORESTIER, MD

    Recruiting

  • Centre Hospitalier Châteaubriant Nozay Pouancé

    Châteaubriant, 44 110

    Pascal GICQUEL, MD, +332 40 55 88 88, pascal.gicquel@ch-cnp.fr

    Pascal GICQUEL, MD

    Recruiting

  • Hôpital Beaujon

    Clichy, 92110

    Victoire Dor De Lastours, MD, +33171114620, victoire.de-lastours@aphp.fr

    Victoire Dor De Lastours, MD

    Recruiting

  • Hôpitaux Civils de Colmar

    Colmar, 68000

    Martin Martineau, MD, +33389124078, martin.martinot@ch-colmar.fr

    Martin Martineau, MD

    Recruiting

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130

    Tomasz CHROBOCZEK, MD

    Tomasz CHROBOCZEK, MD

    Recruiting

  • Centre hopsitalier Sud Francilien

    Corbeil-Essonnes, 91106

    Amélie Chabrol, MD, +33161696615, amelie.chabrol@chsf.fr

    Amélie Chabrol, MD

    Recruiting

  • Centre Hospitalier Intercommunal

    Créteil, 94 000

    Valérie GARRAIT, MD, +33145175000

    Valérie GARRAIT

    Recruiting

  • Hôpital Henry Mondor

    Créteil, 94000

    William Vindrios, MD, +331145178109, william.vindrios@aphp.fr

    William Vindrios, MD

    Recruiting

  • CHU Dijon Bourgogne

    Dijon, 21079

    Lionel Piroth, MD, +33380295475, lionel.piroth@chu-dijon.fr

    Lionel D Piroth, MD

    Recruiting

  • Hôpital de Garches

    Garches, 92380

    Aurélien Dihn, MD, +33147107752, aurelien.dinh@aphp.fr

    Aurélien Dihn, MD

    Recruiting

  • Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre, 94270

    Simon BESSIS, MD, +33145217300, simon.bessis@aphp.fr

    Simon Bessis, MD

    Not yet recruiting

  • Hôpital SALENGRO

    Lille, 59000

    Julien POISSY, MD, +33 3 20 44 59 62, Julien.POISSY@chu-lille.fr

    Julien POISSY, MD

    Recruiting

  • CHU Limoges

    Limoges, 87100

    Jean-François Faucher, MD, +33555055555, jean-francois.faucher@unilim.fr

    Jean-François Faucher, MD

    Recruiting

  • Hospices Civils de Lyon

    Lyon, 69004

    Thomas Perpoint, MD, +33472071107, thomas.perpoint@chu-lyon.fr

    Thomas Perpoint, MD

    Recruiting

  • Centre Hospitalier François Quesnay

    Mantes-la-Jolie, 78200

    Christophe Billy, MD, +33134974000, c.billy@ch-mantes-la-jolie.fr

    Christophe Billy, MD

    Recruiting

  • Hôpital André Grégoire

    Montreuil, 93100

    Guillemette FREMONT, MD, +331 49 20 30 40, guillemette.fremont-goudot@ght-gpne.fr

    Guillemette FREMONT, MD

    Recruiting

  • Hopital Confluent

    Nantes, 44 000

    Olivier GROSSI, MD, +332 28 25 56 15, dr.grossi@groupeconfluent.fr

    Olivier GROSSI, MD

    Recruiting

  • CHU Nantes

    Nantes

    François Raffi, MD, +33240083112, francois.raffi@wanadoo.fr

    François Raffi, MD

    Recruiting

  • American Hospital of Paris

    Neuilly-sur-Seine, 92 200

    Christophe RAPP, MD, +33146412728, christophe.rapp@ahparis.org

    Christophe RAPP, MD

    Recruiting

  • Hôpital Archet

    Nice

    Véronique Mondain, MD, +33492035452, mondain.v@chu-nice.fr

    Véronique Mondain, MD

    Recruiting

  • Hôpital Carémeau

    Nîmes, 30029

    Didier LAUREILLARD, MD, +33466684149, DIDIER.LAUREILLARD@chu-nimes.fr

    Didier LAUREILLARD, MD

    Recruiting

  • Centre Hospitalier du Centre-Bretagne

    Noyal-Pontivy, 56920

    Laurent BELLEC, MD, +332 97 79 00 05, Laurent.BELLEC@ch-centre-bretagne.fr

    Laurent BELLEC, MD

    Recruiting

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris, 75 012

    Delphine FEYEUX, MD, DFeyeux@hopital-dcss.org

    Delphine FEYEUX, MD

    Recruiting

  • HôpitalSaint Antoine

    Paris, 75012

    Jérôme Pacanowski, MD, +33149282438, jerome.pacanowski@aphp.fr

    Jérome Pacanowski, MD

    Recruiting

  • hôpital Cochin

    Paris, 75014

    Luc Mouthon, MD, +33158411436, luc.mouthon@aphp.fr

    Luc Mouthon, MD

    Not yet recruiting

  • Hôpital Necker

    Paris, 75015

    Fanny Lanternier, MD, +33144381742, fanny.lanternier@aphp.fr

    Fanny Lanternier, MD

    Recruiting

  • Hôpital Bichat

    Paris, 75019

    Xavier Lescure, Pr, +33140258080, xavier.lescure@aphp.fr

    Xavier Lescure, Pr

    Recruiting

  • Hôpital Tenon

    Paris, 75020

    Gilles Pialoux, MD, +33156017412, gilles.pialoux@aphp.fr

    Gilles Pialoux, MD

    Recruiting

  • Hôpital Saint Louis

    Paris, 75475

    Jean-Michel Molina, MD, +33142494117, jean-michel.molina@aphp.fr

    Jean-Michel Molina, MD

    Recruiting

  • Centre hospitalier de Perigueux

    Périgueux, 24 019

    Jean-benoit ZABBE, MD, jean-benoit.zabbe@ch-perigueux.fr

    Jean-benoit ZABBE, MD

    Recruiting

  • CHI de Poissy/Saint-Germain-en-Laye

    Poissy, 78300

    Yves WELKER, MD, +33139274125, Yves.Welker@ght-yvelinesnord.fr

    Yves WELKER, MD

    Not yet recruiting

  • CHU

    Reims, 51092

    Firouze Banisadr, MD, +33326787186, fbanisadr@chu-reims.fr

    Firouze Banisadr, MD

    Not yet recruiting

  • Hôpital Pontchaillou

    Rennes, 35033

    Jean-Marc Chapplain, MD, +33299284321, jean-marc.chapplain@chu-rennes.fr

    Jean-Marc Chapplain, MD

    Recruiting

  • Hôpital Charles Nicoll

    Rouen, 76038

    Kevin Alexandre, Dr, +33232888739, kevin.alexandre@chu-rouen.fr

    Kevin Alexandre, MD

    Recruiting

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, 94160

    Cecile Ficko, MD, +33143985000, cecile.ficko@intradef.gouv.fr

    Cécile Ficko, MD

    Not yet recruiting

  • Nouvel Hopital Civil

    Strasbourg, 67000

    Nicolas Lefebvre, MD, +33388116768, nicolas.lefebvre@chru-strasbourg.fr

    Nicolas Lefebvre, MD

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    Philippe Lesprit, MD, +33146252525, p.lesprit@hopital-foch.com

    Philippe Lesprit, MD

    Recruiting

  • Hôpital Purpan

    Toulouse, 31300

    Guillame Martin-Blondel, MD, +33561779117, martin-blondel.g@chu-toulouse.fr

    Guillame Martin-Blondel, MD

    Recruiting

  • Centre hospitalier de Tourcoing

    Tourcoing, 59200

    Olivier Robineau, MD, +33320694616, olivier.robineau82@gmail.com

    Olivier Robineau, MD

    Recruiting

  • CHU Tours

    Tours

    Louis Bernard, MD, +33247473714, louis.bernard@univ-tours.fr

    Louis Bernard, MD

    Recruiting

  • Centre Hospitalier de Valence

    Valence, 26 000

    Julien SAISON, MD, jsaison@ch-valence.fr

    Julien SAISON, MD

    Recruiting

  • Centre hospitalier de Valenciennes

    Valenciennes, 59 300

    Nicolas KADER ETTAHAR, MD, +333 27 14 33 33, ettahar-n@ch-valenciennes.fr

    Nicolas KADER ETTAHAR, MD

    Recruiting

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

    François Goehringer, MD, +33383154800, f.goehringer@chru-nancy.fr

    François Goehringer, MD

    Recruiting

  • Centre Hospitalier Bretagne Atlantique

    Vannes, 56 000

    Marie GOUSSEFF, MD, +332 97 01 41 41, marie.gousseff@ch-bretagne-atlantique.fr

    Marie GOUSSEFF, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Fanny POMMERET, MD, +331 42 11 42 11, fanny.pommeret@gustaveroussy.fr

    Fanny POMMERET, MD

    Recruiting

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges, 94190

    Pauline Carreaux Paz, MD, +33143862000, pauline.caraux-paz@chiv.fr

    Pauline Carreaux Paz, MD

    Recruiting

Other trials in France

Martinique1 site, 1 recruiting

  • André Zobda Cabié

    Fort-de-France, Martinique France, 97200

    André Z Cabié, MD, +33596559673, andre.cabie@chu-martinique.fr

    André Cabié, MD

    Recruiting

Other trials in Martinique

About this study

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.

Read the 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.

Being tested
Data collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

    Data collection

Study groups in NCT04863547
Study groupRoleWhat they receive
ExposedPatients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1
Receives: Other: Data collection
Non exposedPatients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: between the first day of hospitalization and Day 29

  2. To estimate the proportion of Mortality

    Percentage of mortality

    Measured: Day 29

  3. To estimate the proportion of WHO score > 5

    Percentage of WHO score > 5

    Measured: between the first day of hospitalization and Day 29

  4. To estimate the proportion of Patient who received critical care

    Percentage of patients who received critical care

    Measured: between the first day of hospitalization and Day 29

  5. To estimate the proportion of patients who had invasive ventilation

    Percentage of patients who had invasive ventilation

    Measured: between the first day of hospitalization and Day 29

  6. To estimate the proportion of patients who had high flow oxygen therapy

    Percentage of patients who had high flow oxygen therapy

    Measured: between the first day of hospitalization and Day 29

  7. 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

    Measured: between first day of symptoms and the first day of hospitalization assessed up to one month

  8. 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

    Measured: between first day of symptoms and the first day of hospitalization assessed up to one month

  9. Time between the first day of symptoms and the severity of disease

    Time between the first day of symptoms and the severity of disease

    Measured: between first day of symptoms and the severity assessed up to one month

  10. Time between the first day of symptoms and mortality

    Time between the first day of symptoms and mortality

    Measured: between first day of symptoms and mortality assessed up to two month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start11 Mar 2021
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
2,200 participants (estimated)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT04863547
Sponsor's protocol ID
ANRS 0007S SEVASAR
Acronym
SEVASAR
Status last verified
Apr 2021
First submitted
8 Apr 2021
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by ANRS, Emerging Infectious Diseases at 53 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xavier Lescure, Pr (0140258080, xavier.lescure@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To estimate the proportion of Severe disease form (time frame: between the first day of hospitalization and Day 29). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04863547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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