NCT04906850

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 25, 2021

Last Update Submit

May 28, 2021

Conditions

Covid19

Keywords

MortalitySARS-CoV-2 variantsIntensive Care Unit20I/501Y.V120H/501Y.V2

Outcome Measures

Primary Outcomes (1)

  • Mortality 28 days after admission

    Vital status 28 days after admission in Intensive Care Unit

    Day 28

Secondary Outcomes (1)

  • ICU mortality

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Opposed to use data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU Nancy

Nancy, Meurthe-et-moselle, 54000, France

Location

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

Related Publications (1)

  • 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.

    PMID: 35360736DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

March 1, 2021

Primary Completion

April 15, 2021

Study Completion

May 15, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations

FR(2)