Sotrovimab Expanded Access Treatment Protocol (COVID-19)

Sponsor
Vir Biotechnology, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT05235347
Collaborator
(none)
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Sotrovimab

Study Design

Study Type:
Expanded Access
Official Title:
Sotrovimab Expanded Access Treatment Protocol

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Palo Alto California United States 94304
    2 Site Boston Massachusetts United States 02114
    3 Site Saint Louis Missouri United States 63110
    4 Site Seattle Washington United States 98109

    Sponsors and Collaborators

    • Vir Biotechnology, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vir Biotechnology, Inc.
    ClinicalTrials.gov Identifier:
    NCT05235347
    Other Study ID Numbers:
    • VIR-7831-6406
    First Posted:
    Feb 11, 2022
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Vir Biotechnology, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 22, 2022