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CompletedNCT04906850VARICOVIDUpdated Jun 2, 2021

Evaluation of the New Variant 501Y.V2 of COVID-19

An observational study in Covid19, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
250
Ages
18 Years and older
Sex
All
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Study summary

In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 ("English"), 20H/501Y.V2 ("South African"), and 20J/501Y.V3 ("Brazilian") variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.

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Conditions studied

  • Covid19

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Keywords

  • Mortality
  • SARS-CoV-2 variants
  • Intensive Care Unit
  • 20I/501Y.V1
  • 20H/501Y.V2
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 250 is close to the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with 20I/501Y.V1 ("English") or 20H/501Y.V2 ("South African") SARS-CoV-2 variants

Inclusion criteria

  • Admission in ICU in February, March or April 2021
  • Patient with a SARS-CoV-2 positive polymerase-chain reaction test
  • Patient with 20I/501Y.V1 ("English") or 20H/501Y.V2 ("South African") SARS-CoV-2 variants

Exclusion criteria

Exclusion Criteria:

  • Opposed to use data
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
250 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Mortality 28 days after admission

    Vital status 28 days after admission in Intensive Care Unit

    Time frame: Day 28

Secondary outcomes

  1. ICU mortality

    Percentage of mortality in Intensive Care Unit

    Time frame: Day 1

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Study locations

2 sites
  • CHRU Nancy
    Nancy, Meurthe-et-moselle 54000, France
  • CHR Metz Thionville
    Metz, Moselle 57085, France
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References and documents

Publications

  • Louis G, Belveyre T, Goetz C, Gibot S, Dunand P, Conrad M, Gaci R, Gette S, Ouamara N, Perez P, Cadoz C, Picard Y, Mellati N. Comparison of SARS-CoV-2 Variants of Concern Alpha (B.1.1.7) vs. Beta (B.1.351) in Critically Ill Patients: A Multicenter Cohort Study. Front Med (Lausanne). 2022 Mar 10;9:828402. doi: 10.3389/fmed.2022.828402. eCollection 2022. PubMed 35360736 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04906850
Lead sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
May 28, 2021
Start date
Mar 1, 2021
Primary completion
Apr 15, 2021
Completion
May 15, 2021
Last update
Jun 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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