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OpenTrials
Completed

NCT Number: NCT04906850

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy, Nancy, Meurthe-et-moselle, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Opposed to use data

Treatment and study plan

Primary outcomes

  1. Mortality 28 days after admission

    Time frame: Day 28

    Vital status 28 days after admission in Intensive Care Unit

Secondary outcomes

  1. ICU mortality

    Time frame: Day 1

    Percentage of mortality in Intensive Care Unit

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Collaborators

  • Central Hospital, Nancy, France

Registry information

Official study title

Comparison of Mortality in Severe SARS-Cov-2 Infection Caused by the 501Y.V2 Variant and B.1.1.7 Variant

Acronym: VARICOVID

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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