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Sotrovimab Expanded Access Treatment Protocol (COVID-19)

Primary Purpose

Covid19

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Sotrovimab
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Covid19 focused on measuring SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • In the opinion of the investigator, meets the current Emergency Use Authorization (EUA) eligibility criteria for sotrovimab

OR

  • patients currently hospitalized for a non-COVID-19 illness who acquire COVID-19 (nosocomial infection) and otherwise meets all the current EUA eligibility criteria

Exclusion Criteria:

  • Hospitalized due to COVID-19 (excludes nosocomial infection)
  • Require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19

Sites / Locations

  • Site
  • Site
  • Site
  • Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 13, 2022
Last Updated
November 4, 2022
Sponsor
Vir Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05235347
Brief Title
Sotrovimab Expanded Access Treatment Protocol (COVID-19)
Official Title
Sotrovimab Expanded Access Treatment Protocol
Study Type
Expanded Access

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.

4. Oversight

5. Study Description

Brief Summary
An expanded access program for sotrovimab administered intravenously to participants with COVID-19 illness who meet current authorized/approved criteria for use of sotrovimab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Sotrovimab
Intervention Description
500mg IV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Eligibility Criteria
Inclusion Criteria: In the opinion of the investigator, meets the current Emergency Use Authorization (EUA) eligibility criteria for sotrovimab OR patients currently hospitalized for a non-COVID-19 illness who acquire COVID-19 (nosocomial infection) and otherwise meets all the current EUA eligibility criteria Exclusion Criteria: Hospitalized due to COVID-19 (excludes nosocomial infection) Require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19
Facility Information:
Facility Name
Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sotrovimab Expanded Access Treatment Protocol (COVID-19)

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