Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19. Substudy: Intravenous Single Ascending Dose VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04913675 |
|
Recruitment Status :
Active, not recruiting
First Posted : June 4, 2021
Last Update Posted : July 26, 2022
|
Sponsor:
Vir Biotechnology, Inc.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Brief Summary:
A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients; Safety Substudy assessing the safety and tolerability of single ascending dose monoclonal antibody VIR-7831
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 | Biological: VIR-7831 sotrovimab Biological: VIR-7831 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831 |
| Actual Study Start Date : | June 10, 2021 |
| Estimated Primary Completion Date : | July 19, 2022 |
| Estimated Study Completion Date : | August 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
|
Experimental: VIR-7831 (Sotrovimab)
Main Study participants will be randomized to receive VIR-7831 by intramuscular injection or intravenous infusion
|
Biological: VIR-7831 sotrovimab
Participants will be randomized to receive IV infusion or IM injection of sotrovimab |
|
Experimental: Safety Substudy VIR 7831 (Sotrovimab)
Cohort A: Dose 1 infused IV over 60 min Optional Cohort B1: Dose 1 infused IV over 30 min Optional Cohort B2: Dose 1 infused IV over 15 min Optional Cohort C: Dose 2 infused IV over 90 min |
Biological: VIR-7831
Participants will receive IV infusion of sotrovimab |
Primary Outcome Measures :
- Progression of COVID-19 in Main Study [ Time Frame: Up to Day 29 ]Hospitalization > 24 hours for acute management of illness due to any cause OR Death
- Occurrence of adverse events (AEs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
- Occurrence of serious adverse events (SAEs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
- Occurrence of adverse events of special interest (AESIs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
- Occurrence of disease related events (DREs) in Safety Sub-study [ Time Frame: Up to Day 8 ]
Secondary Outcome Measures :
- Occurence of of adverse events (AEs) In Main Study [ Time Frame: Up to 24 weeks ]
- Occurrence of serious adverse events (SAEs) in Main Study [ Time Frame: Up to 24 weeks ]
- Occurrence of adverse events of special interest (AESI) in Main Study [ Time Frame: Up to 24 weeks ]
- Occurrence of disease related events (DRE) in Main Study [ Time Frame: Up to 24 weeks ]
- Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab in Main Study [ Time Frame: Up to 24 weeks ]
- Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab in Main Study [ Time Frame: Up to 24 weeks ]
- Progression of COVID-19 in Main Study [ Time Frame: Up to 24 weeks ]Visit to a hospital emergency room for management of illness OR Hospitalization for acute management of illness for any duration and for any cause OR Death
- Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR in Main Study [ Time Frame: Up to Day 8 ]
- Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR in Main Study [ Time Frame: Up to Day 8 ]
- Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR) in Main Study [ Time Frame: Up to Day 8 ]
- Occurrence of adverse events (AEs) in Safety Sub-study [ Time Frame: up to Week 12 ]
- Occurrence of serious adverse events (SAEs) in Safety Sub-study [ Time Frame: up to Week 36 ]
- Occurrence of adverse events of special interest (AESIs) in Safety Sub-study [ Time Frame: up to Week 12 ]
- Occurrence of disease related events (DREs) in Safety Sub-study [ Time Frame: up to Week 12 ]
- Incidence and titers (if applicable) of serum anti-drug antibody (ADA) and neutralizing antibody (if applicable) to sotrovimab in Safety Sub-study [ Time Frame: up to Week 24 ]
- Intramuscular serum concentration (IM) in Main Study [ Time Frame: Day 29 ]
- Intravenous serum concentration (IV) in Main Study [ Time Frame: Day 29 ]
- Intravenous serum concentration (IV) in Safety Sub-Study [ Time Frame: up to Week 24 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Main Study participant must be aged 12 years or older and Sub-Study participants must be aged 18 years or older at time of consent AND at high risk of progression of COVID-19 or ≥ 55 years old
- Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 7 days from onset of symptoms
Exclusion Criteria:
- Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
- Symptoms consistent with severe COVID-19
- Participants who, in the judgement of the investigator are likely to die in the next 7 days
- Known hypersensitivity to any constituent present in the investigational product
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913675
Locations
Show 50 study locations
Sponsors and Collaborators
Vir Biotechnology, Inc.
GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vir Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT04913675 |
| Other Study ID Numbers: |
VIR-7831-5008 |
| First Posted: | June 4, 2021 Key Record Dates |
| Last Update Posted: | July 26, 2022 |
| Last Verified: | July 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Vir Biotechnology, Inc.:
|
SARS-CoV-2 coronavirus coronavirus disease 2019 COVID-19 |
Additional relevant MeSH terms:
|
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |