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
Finalized
Finalized
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
Observational study model:
Case-Control
Primary completion date:
2023-19-05
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)

No location data available.

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
Finalized
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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