Last updated: 01/30/2025 05:40:54

Discover-NOW sotrovimab comparative effectiveness study

GSK study ID
219543
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: A comparative effectiveness study of COVID-19 patients treated with Sotrovimab and untreated controls in England – DISCOVER-NOW Database study
Trial description: This is purely retrospective cohort design analysis conducted using pre-existing electronic healthcare records (EHR) in the DISCOVER-NOW database. The overall aim of the study is to assess, in a non-hospitalized setting, the comparative effectiveness of sotrovimab compared to no anti-Coronavirus disease 2019 (COVID-19) treatments in preventing COVID-19 related hospitalizations amongst individuals at high-risk of progression to severe COVID-19. The study will include participants diagnosed with COVID-19 from 1st December 2021 onwards.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number and proportion of participants hospitalized due to COVID-19

Timeframe: Up to Day 28

Hazard of COVID-19 hospitalization and/or death for sotrovimab treated vs untreated cohorts

Timeframe: Up to Day 28

Secondary outcomes:

Hazard Ratio of COVID-19 hospitalization within 28 days of index date between sotrovimab-treated and untreated patients, stratified by: BA.2 variant prevalence period, Age at index, COVID-19 vaccination status

Timeframe: Up to Day 28

Rates of COVID-19 hospitalization between sotrovimab-treated and untreated patients, in subsets where: all patients have a renal dysfunction, all patients are receiving immunosuppressant drug

Timeframe: Up to Day 28

Interventions:
  • Drug: Sotrovimab
    • Enrollment:
    0
    Primary completion date:
    2023-19-05
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Myriam Drysdale, Evgeniy R Galimov, Marcus James Yarwood, Vishal Patel, Bethany Levick, Daniel C Gibbons, Jonathan D Watkins, Sophie Young, Benjamin F Pierce, Emily J Lloyd, William Kerr, Helen J Birch, Tahereh Kamalati, Stephen J Brett. Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study. BMJ open respiratory research. 2024-04-04;11(1) DOI :10.1136/bmjresp-2023-002238 PMID: 38575338
    Medical condition
    COVID-19
    Product
    sotrovimab
    Collaborators
    Not applicable
    Study date(s)
    November 2022 to May 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • COVID-19 diagnosis or positive PCR test, or treatment with sotrovimab (to the treated cohort only)
    • Aged greater than or equal to (≥) 12 years as of their index date
    • Participants who have received nirmatrelvir/ritonavir, molnupiravir, or remdesivir while not hospitalized before the index date (number excluded to be reported stratified by whether sotrovimab was also received for the same acute period, and the number remaining who subsequently receive any agent after index to be reported)
    • Participants who are diagnosed with COVID-19 while hospitalized
    Inclusion and exclusion criteria
    Inclusion criteria:
    • COVID-19 diagnosis or positive PCR test, or treatment with sotrovimab (to the treated cohort only)
    • Aged greater than or equal to (≥) 12 years as of their index date
    • Participants with at least one of the high-risk criteria for receiving early treatment with sotrovimab, nirmatrelvir/ritonavir, or molnupiravir
    Exclusion criteria:
    • Participants who have received nirmatrelvir/ritonavir, molnupiravir, or remdesivir while not hospitalized before the index date (number excluded to be reported stratified by whether sotrovimab was also received for the same acute period, and the number remaining who subsequently receive any agent after index to be reported)

      • Participants who are diagnosed with COVID-19 while hospitalized (The number and proportion of patients receiving multiple prescriptions of Sotrovimab will also be reported. These patients will not be excluded) The population will be analyzed as two cohorts:

      • The treated cohort, who have a recorded prescription for Sotrovimab within 28 days of their COVID-19 diagnosis,
      • The untreated cohort, who do not have a recorded prescription for Sotrovimab within 28 days of their COVID-19 diagnosis

    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
    2023-19-05
    Actual study completion date
    2023-19-05

    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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    Access to clinical trial data by researchers
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