NCT05235347

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

First QC Date

January 13, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

SARS-CoV-2coronaviruscoronavirus disease 2019COVID-19

Interventions

SotrovimabBIOLOGICAL

500mg IV

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In the opinion of the investigator, meets the current Emergency Use Authorization (EUA) eligibility criteria for sotrovimab
  • patients currently hospitalized for a non-COVID-19 illness who acquire COVID-19 (nosocomial infection) and otherwise meets all the current EUA eligibility criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Site

Palo Alto, California, 94304, United States

Location

Site

Boston, Massachusetts, 02114, United States

Location

Site

St Louis, Missouri, 63110, United States

Location

Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 11, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Locations