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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1 | Other: Data collection<br>* Data collection<br>|
| Non exposed<br>Patients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2 | Other: Data collection<br>* Data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the proportion of Severe disease form | Percentage 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. | between the first day of hospitalization and Day 29 | 
| To estimate the proportion of Mortality | Percentage of mortality | Day 29 | 
| To estimate the proportion of WHO score > 5 | Percentage of WHO score > 5 | between the first day of hospitalization and Day 29 | 
| To estimate the proportion of Patient who received critical care | Percentage of patients who received critical care | between the first day of hospitalization and Day 29 | 
| To estimate the proportion of patients who had invasive ventilation | Percentage of patients who had invasive ventilation | between the first day of hospitalization and Day 29 | 
| To estimate the proportion of patients who had high flow oxygen therapy | Percentage of patients who had high flow oxygen therapy | between the first day of hospitalization and Day 29 | 
| Time between the first day of symptoms and the first day of hospitalization | Time between the first day of symptoms and the first day of hospitalization | between first day of symptoms and the first day of hospitalization assessed up to one month | 
| Delay between the first day of symptoms and the first day of hospitalization | Time between the first day of symptoms and the first day of hospitalization | between first day of symptoms and the first day of hospitalization assessed up to one month | 
| Time between the first day of symptoms and the severity of disease | Time between the first day of symptoms and the severity of disease | between first day of symptoms and the severity assessed up to one month | 
| Time between the first day of symptoms and mortality | Time between the first day of symptoms and mortality | between first day of symptoms and mortality assessed up to two month |