Last updated: 06/16/2025 11:40:37

Real-World Effectiveness of Sotrovimab in the Treatment of Participants with Coronavirus Disease 2019 (COVID-19)

GSK study ID
218266
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 Effectiveness of a Sotrovimab-Treated Cohort Compared with a Control Cohort (eligible for monoclonal antibody treatment, but not receiving) for the Early Treatment of COVID-19: Evidence from Mayo Clinic’s Electronic Health Records
Trial description: This is an observational, retrospective study based on the analysis of electronic health record (EHR) data from the Mayo Clinic. This study evaluates the real-world effectiveness of Sotrovimab with respect to reducing the risk of hospitalization and mortality. Also, the study design has 2 observation periods PART A for Real-World Comparative Outcomes and PART B for Real-World Treatment Patterns.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants hospitalized due to any cause (all-cause hospitalization)

Timeframe: Up to Day 29

Number of participants with all-cause mortality

Timeframe: Up to Day 29

Number of participants hospitalized or who died due to any cause

Timeframe: Up to Day 29

Secondary outcomes:

Number of participants hospitalized due to COVID-19

Timeframe: Up to Day 29

Number of participants with COVID-19 related mortality

Timeframe: Up to Day 29

Number of participants hospitalized due to COVID-19 or who died due to COVID-19

Timeframe: Up to Day 29

Number of participants with Intensive care unit (ICU) admission

Timeframe: Up to Day 29

Number of participants with respiratory support

Timeframe: Up to Day 29

Length of hospitalization

Timeframe: Up to Day 29

Number of participants with emergency department visits (all-cause and COVID-19-related)

Timeframe: Up to Day 29

Number of participants with outpatient physician visits (all-cause and COVID-19- related)

Timeframe: Up to Day 29

Number of days from positive COVID-19 test to treatment of interest for treatment cohorts only

Timeframe: Up to Day 29

Number of days from positive COVID-19 test to first hospitalization

Timeframe: Up to Day 29

Number of days from positive COVID-19 test to first ER visit

Timeframe: Up to Day 29

Number of days from positive COVID-19 test to death

Timeframe: Up to Day 29

Number of days from treatment to first ER visit

Timeframe: Up to Day 29

Number of days from treatment to first hospitalization

Timeframe: Up to Day 29

Number of days from treatment to death

Timeframe: Up to Day 29

Interventions:
  • Drug: Sotrovimab
    • Enrollment:
    0
    Primary completion date:
    2023-23-04
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Christopher F Bell, Daniel C Gibbons, Myriam Drysdale, Helen J Birch, Emily J Lloyd, Vishal Patel, Corinne Carpenter, Katherine Carlson, Ediz S Calay, Arjun Puranik, Tyler E Wagner, John C O'Horo, Raymund R Razonable. Real-world effectiveness of sotrovimab in preventing hospitalization and mortality in high-risk patients with COVID-19 in the United States: A cohort study from the Mayo Clinic electronic health records.. PloS one. 2024-07-16;19(7): e0304822. PMID: 39012863 DOI: 10.1371/journal.pone.0304822
    Medical condition
    Virus Diseases, COVID-19
    Product
    sotrovimab
    Collaborators
    Not applicable
    Study date(s)
    July 2022 to April 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Part A and B:
    • Age greater than or equal to (≥) 18 years old
    • Part A and B:
    • Hospitalization in the 14 days prior to and including the treatment date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Part A and B:
    • Age greater than or equal to (≥) 18 years old
    • A positive PCR test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or diagnosis of COVID-19
    • At high risk for progression of COVID-19 to severe illness; i.e., meet Emergency use authorization (EUA) criteria for Sotrovimab
    • Sufficient data to determine vital status at Day 29, deemed as either a. Continuous follow-up through Day 29, or b. Death occurring in the acute follow-up period Part A:
    • Treatment cohorts a. Sotrovimab Cohort: received treatment with Sotrovimab within 10 days of positive test in an outpatient or ER setting b. Control cohort: did not receive any mAb or antiviral therapy for treatment of COVID-19 or for PrEP, in any setting Part B:
    • Treatment cohorts a. Approach #1: Index Date Starting with the index date (earliest of a positive test for SARS- CoV-2 or the date of COVID-19 diagnosis), cohorts will be defined on the basis of the first outpatient or ER treatment received within 10 days of the index date; e.g., Sotrovimab, other mAb (bamlanivimab, bamlanivimab-etesevimab, casirivimab- imdevimab, bebtelovimab), or antiviral (paxlovid, molnupiravir or remdesivir) Patient not receiving treatment within 10 days of the index date will be assigned to the Control cohort b. Approach #2: Treatment Date Starting with the index date (earliest of a positive test for SARS- CoV-2 or the date of COVID-19 diagnosis), cohorts will be defined on the basis of the first outpatient or ER treatment received within 10 days of the index date; e.g., Sotrovimab, other mAb (bamlanivimab, bamlanivimab-etesevimab, casirivimab- imdevimab, bebtelovimab), or antiviral (paxlovid, molnupiravir or remdesivir)
    Exclusion criteria:
    • Part A and B:
    • Hospitalization in the 14 days prior to and including the treatment date
    • Previously administered a mAb (e.g., bamlanivimab, bamlanivimab-etesevimab, casirivimab-imdevimab, bebtelovimab), antiviral (paxlovid, molnupiravir, or remdesivir), or tixagevimab-cilgavimab12 months prior to the treatment date Part A:
    • Administered Sotrovimab ≥10 days after 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
    2023-23-04
    Actual study completion date
    2023-23-04

    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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