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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04863547
Acronym
SEVASAR
Enrollment
2200
Registered
2021-04-28
Start date
2021-03-11
Completion date
2021-05-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERData collection

Data collection

Sponsors

ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To estimate the proportion of Severe disease formbetween the first day of hospitalization and Day 29Percentage 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.
To estimate the proportion of MortalityDay 29Percentage of mortality
To estimate the proportion of WHO score > 5between the first day of hospitalization and Day 29Percentage of WHO score \> 5
To estimate the proportion of Patient who received critical carebetween the first day of hospitalization and Day 29Percentage of patients who received critical care
To estimate the proportion of patients who had invasive ventilationbetween the first day of hospitalization and Day 29Percentage of patients who had invasive ventilation
To estimate the proportion of patients who had high flow oxygen therapybetween the first day of hospitalization and Day 29Percentage of patients who had high flow oxygen therapy
Time between the first day of symptoms and the first day of hospitalizationbetween first day of symptoms and the first day of hospitalization assessed up to one monthTime between the first day of symptoms and the first day of hospitalization
Delay between the first day of symptoms and the first day of hospitalizationbetween first day of symptoms and the first day of hospitalization assessed up to one monthTime between the first day of symptoms and the first day of hospitalization
Time between the first day of symptoms and the severity of diseasebetween first day of symptoms and the severity assessed up to one monthTime between the first day of symptoms and the severity of disease
Time between the first day of symptoms and mortalitybetween first day of symptoms and mortality assessed up to two monthTime between the first day of symptoms and mortality

Countries

France, Martinique

Contacts

Primary ContactXavier Lescure, Pr
xavier.lescure@aphp.fr0140258080
Backup ContactGuillaume Martin-Blondel, Pr
martin-blondel.g@chu-toulouse.fr0561779699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026