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ClinicalTrials.gov ID

NCT04863547

Lead Sponsor

ANRS, Emerging Infectious DiseasesOTHER_GOV

Overall Status

Unknown status

Study Type

Observational

Enrollment

2,200Estimated

Last Update Posted

Apr 28, 2021Actual

Start Date

Mar 11, 2021Actual

Primary Completion Date

Apr 30, 2021Estimated

Completion Date

May 31, 2021Estimated

Official Title

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

Brief 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. 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.

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.

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

• Data collection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Other

Time Perspective

Other

Lead Sponsor

ANRS, Emerging Infectious DiseasesOTHER_GOV

vincent.dubee@chu-angers.fr+33241353930

francois.raffi@wanadoo.fr+33240083112

mondain.v@chu-nice.fr+33492035452

louis.bernard@univ-tours.fr+33247473714