Last updated: 04/04/2025 04:40:40

Real-world effectiveness of sotrovimab in preventing acute outcomes against different variants of SARS-CoV-2

GSK study ID
219589
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real-world comparative effectiveness of sotrovimab versus no treatment in preventing acute outcomes associated with COVID- 19: An analysis of administrative claims data from Komodo Health
Trial description: This is a retrospective, observational, administrative claims analysis conducted using Komodo Health data among individuals diagnosed with Coronavirus disease 2019 (COVID-19). The study will evaluate real-world outcomes of hospitalization and mortality among a cohort of high-risk, non-hospitalized participants with mild/moderate COVID-19. who receive treatment with Sotrovimab compared to a matched cohort of participants eligible for treatment, but not receiving any monoclonal antibodies (mAbs) or antivirals for COVID-19.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of participants with all-cause hospitalization

Timeframe: Up to Day 29

Secondary outcomes:

Proportion of participants with all-cause mortality

Timeframe: Up to Day 60

Proportion of participants with all-cause hospitalization and/or all-cause mortality

Timeframe: Up to Day 60

Proportion of participants with intensive care unit (ICU) admission

Timeframe: Up to Day 29

Number of participants with maximum respiratory support level during hospitalization

Timeframe: Up to Day 29

Length of hospitalization of inpatient event

Timeframe: Up to Day 29

Proportion of participants with COVID-19 related hospitalization

Timeframe: Up to Day 29

Proportion of participants with all-cause ER admission

Timeframe: Up to Day 29

Proportion of participants with COVID-19 related ER admission

Timeframe: Up to Day 29

Time in days to first all-cause hospitalization/ER event

Timeframe: Up to Day 29

Interventions:
  • Drug: Sotrovimab
    • Enrollment:
    0
    Primary completion date:
    2023-28-04
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Christopher F Bell, Tasneem Lokhandwala, Daniel C Gibbons, Myriam Drysdale, Jane Wang, Emily J Lloyd. Real-World Effectiveness of Sotrovimab in Ambulatory Patients With COVID-19: A Retrospective Cohort Study Using a Large Administrative Claims Database in the United States. Clinical therapeutics. 2025-Feb-04; doi:10.1016/j.clinthera.2025.01.003 https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(25)00004-9 PMID: 39909767 DOI: 10.1016/j.clinthera.2025.01.003
    Medical condition
    COVID-19
    Product
    sotrovimab
    Collaborators
    Not applicable
    Study date(s)
    January 2023 to April 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Sotrovimab Group
    • Participants greater than or equal to (≥)12 years of age
    • Participants less than (<) 12 years of age
    • Non-continuous enrollment in medical and pharmacy benefits during the 12-month baseline period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Sotrovimab Group
    • Participants greater than or equal to (≥)12 years of age
    • Received Sotrovimab in an outpatient or ER setting from May 26, 2021, through April 5, 2022, with a COVID-19 diagnosis within the 10 days prior to or on the index date
    • At high risk for progression of COVID-19 to severe illness, i.e., meet Emergency Use Authorization (EUA) criteria for Sotrovimab Control Group
    • Participants ≥ 12 years of age
    • Diagnosed with COVID-19 in the ambulatory setting of care between May 16, 2021, through March 26, 2022
    • No evidence of outpatient or ER treatment with mAbs) or antiviral agents at any time during the study period
    • At high risk for progression of COVID-19 to severe illness, i.e., meet EUA criteria for Sotrovimab
    Exclusion criteria:
    • Participants less than (<) 12 years of age
    • Non-continuous enrollment in medical and pharmacy benefits during the 12-month baseline period
    • Non-continuous enrollment in medical and pharmacy benefits during the 29-day follow-up period for the Sotrovimab group and over 39 days post COVID-19 diagnosis date for the control group (participants who die on the index date will be excluded)
    • At least 1 claim for mAb or antiviral for the treatment of COVID-19 during the 12-month baseline period or between diagnosis and Sotrovimab treatment initiation date and in the outpatient setting during the 29-day follow-up period
    • Hospitalized or receiving critical care (intubation or mechanical ventilation, extracorporeal membrane oxygenation, critical care services, or intensive care services) in the 14 days prior to and including the index date

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2023-28-04
    Actual study completion date
    2023-28-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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