Status:
COMPLETED
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
Lead Sponsor:
GlaxoSmithKline
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the...
Eligibility Criteria
Inclusion
- Participants must be adult and of greater than or equal to (\>=) 18 years of age or older at the time of consent
- Participants must be immunocompromised (IC) population eligible to receive sotrovimab
- A positive polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 through clinical testing or routine screening undertaken as part of clinical management
- Prescribed treatment with sotrovimab as standard of clinical care
- Able to provide informed consent and willing to adhere to study-related procedures
Exclusion
- Participants who require hospitalization (related or not to COVID-19) at baseline
- Participants who initiated sotrovimab therapy in inpatient settings
- Participants unable to perform nasal/oropharyngeal sample collection
- Blinded participants from other COVID-19 related trials
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2023
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT05305651
Start Date
July 1 2022
End Date
July 17 2023
Last Update
October 15 2024
Active Locations (8)
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1
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
2
GSK Investigational Site
Cardiff, United Kingdom, CF14 4XW
3
GSK Investigational Site
EdgbastonBirmingham, United Kingdom, B15 2GW
4
GSK Investigational Site
London, United Kingdom, NW1 2BU