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

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ClinicalTrials.gov Identifier: NCT04863547
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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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.

Condition or disease Intervention/treatment
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Other: Data collection

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2200 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Weeks
Official Title: Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Exposed
Patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1
 Other: Data collection
Data collection
Non exposed
Patients hospitalized for COVID-19 to SARS-CoV-2 corresponding to wild type 20A variants. EU1 or 20A. EU2
 Other: Data collection
Data collection


Outcome Measures
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Primary Outcome Measures :
  1. To estimate the proportion of Severe disease form [ Time Frame: between the first day of hospitalization and Day 29 ]
    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.

  2. To estimate the proportion of Mortality [ Time Frame: Day 29 ]
    Percentage of mortality

  3. To estimate the proportion of WHO score > 5 [ Time Frame: between the first day of hospitalization and Day 29 ]
    Percentage of WHO score > 5

  4. To estimate the proportion of Patient who received critical care [ Time Frame: between the first day of hospitalization and Day 29 ]
    Percentage of patients who received critical care

  5. To estimate the proportion of patients who had invasive ventilation [ Time Frame: between the first day of hospitalization and Day 29 ]
    Percentage of patients who had invasive ventilation

  6. To estimate the proportion of patients who had high flow oxygen therapy [ Time Frame: between the first day of hospitalization and Day 29 ]
    Percentage of patients who had high flow oxygen therapy

  7. Time between the first day of symptoms and the first day of hospitalization [ Time Frame: 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 first day of hospitalization

  8. Delay between the first day of symptoms and the first day of hospitalization [ Time Frame: 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 first day of hospitalization

  9. Time between the first day of symptoms and the severity of disease [ Time Frame: between first day of symptoms and the severity assessed up to one month ]
    Time between the first day of symptoms and the severity of disease

  10. Time between the first day of symptoms and mortality [ Time Frame: between first day of symptoms and mortality assessed up to two month ]
    Time between the first day of symptoms and mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with Acute symptomatic COVID PCR+ with screening Hospitalized for acute COVID between January 1,2021 (or since the implementation of the screening in the center) and february 28, 2021
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863547


Contacts
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Contact: Xavier Lescure, Pr 0140258080 xavier.lescure@aphp.fr
Contact: Guillaume Martin-Blondel, Pr 0561779699 martin-blondel.g@chu-toulouse.fr

Locations
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Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04863547    
Other Study ID Numbers: ANRS 0007S SEVASAR
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases