Sotrovimab Expanded Access Treatment Protocol (COVID-19) | NCT05235347

Studies
Sotrovimab Expanded Access Treatment Protocol (COVID-19)

NCT05235347

Sponsor

Vir Biotechnology, Inc.

Status

No longer available

Last Update Posted

Nov 10, 2022Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Covid19

Interventions

Sotrovimab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Jan 31, 2022

First Posted Date

Feb 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2022

Last Update Posted Date

Nov 10, 2022Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Treatment IND/Protocol

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Sotrovimab	Biological	500mg IV

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Site		Palo Alto	California	94304	United States
Site

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided