Covid19NCT05235347
Sotrovimab Expanded Access Treatment Protocol (COVID-19)
A study testing Sotrovimab in people with Covid19, run by Vir Biotechnology, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Sotrovimab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site
Boston, Massachusetts, 02114
Site
Palo Alto, California, 94304
Site
Seattle, Washington, 98109
Site
St Louis, Missouri, 63110
About this study
Official title: Sotrovimab Expanded Access Treatment Protocol
An expanded access program for sotrovimab administered intravenously to participants with COVID-19 illness who meet current authorized/approved criteria for use of sotrovimab.
- Conditions
- Covid19
- Being tested
- Sotrovimab
- Keywords
- SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotrovimabBiological
500mg IV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235347
- Sponsor's protocol ID
- VIR-7831-6406
- Status last verified
- Nov 2022
- First submitted
- 13 Jan 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sotrovimab Expanded Access Treatment Protocol
- ClinicalTrials.gov ID
- NCT05235347
- Acronym / sponsor ID
- VIR-7831-6406
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An expanded access program for sotrovimab administered intravenously to participants with COVID-19 illness who meet current authorized/approved criteria for use of sotrovimab.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sotrovimab500mg IV | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sotrovimab in people with Covid19, run by Vir Biotechnology, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.