Sotrovimab Expanded Access Treatment Protocol (COVID-19)

NCT ID: NCT05235347

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sotrovimab

500mg IV

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site

Palo Alto, California, United States

Site Status

Site

Boston, Massachusetts, United States

Site Status

Site

St Louis, Missouri, United States

Site Status

Site

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VIR-7831-6406

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Expanded Access Remdesivir (RDV; GS-5734™)
NCT04302766 NO_LONGER_AVAILABLE