Last updated: 01/30/2025 04:50:20

Descriptive evaluation of the real-world effectiveness of early treatments for SARS-CoV-2

GSK study ID
218263
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 monoclonal antibodies and antiviral treatments in preventing acute outcomes against different variants of SARS-CoV-2: a descriptive analysis of administrative claims data from Komodo Health
Trial description: This is a retrospective, observational, administrative claims analysis conducted using the Komodo Health data among individuals diagnosed with Coronavirus disease 2019 (COVID-19). The study is aimed to describe the real- world clinical outcomes of monoclonal antibody (mAb) and antiviral treatments with respect to the risk of hospitalization and mortality.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with an inpatient event due to any cause (all-cause hospitalization)

Timeframe: Up to Day 29

Secondary outcomes:

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

Timeframe: Up to Day 29

Number of participants with all-cause mortality

Timeframe: Up to Day 29

Number of participants with Intensive care unit (ICU) admission

Timeframe: Up to Day 29

Number of participants with maximum respiratory support during hospitalization

Timeframe: Up to Day 29

Length of hospitalization

Timeframe: Up to Day 29

Number of participants with COVID-19 related hospitalization

Timeframe: Up to Day 29

Number of participants with all-cause ER admission

Timeframe: Up to Day 29

Number of participants with COVID-19 related ER admission

Timeframe: Up to Day 29

Number of days to first all-cause hospitalization/ER event

Timeframe: Up to Day 29

Number of participants with treatment failure in prophylaxis cohort

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:
    Not applicable
    Medical condition
    COVID-19
    Product
    sotrovimab
    Collaborators
    Not applicable
    Study date(s)
    October 2022 to April 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Adults and pediatric participants
    • Early treatment cohorts
    • Participants with age lesser than (<) 12 years
    • Participants with non-continuous enrollment in medical and pharmacy benefits during the 12-month baseline period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adults and pediatric participants Early treatment cohorts
    • Participants on treatment with mAb or antiviral agents in an outpatient or ER setting
    • Participants with a diagnosis of COVID-19 (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM]: U07.1) in an outpatient or ER setting
    • Participants with another mAb or antiviral agent indicated for treatment of COVID-19 before the tixagevimab co-packaged with cilgavimab claim during the identification period will be included in the early treatment cohort Prophylaxis cohort
    • Participants on treatment with the tixagevimab co-packaged with cilgavimab in an outpatient or ER setting No treatment cohort
    • Participants with no evidence of treatment with mAb or antiviral agents at any time within the analysis period
    • Participants with diagnosis of COVID-19 using greater than or equal to (≥) 1 non-diagnostic claim with the ICD-10-CM: U07.1 in an outpatient or ER setting
    • Untreated participants diagnosed around the same time as the early treatment cohorts
    Exclusion criteria:
    • Participants with age lesser than (<) 12 years
    • Participants with non-continuous enrollment in medical and pharmacy benefits during the 12-month baseline period
    • Participants with: 1) Non-continuous enrollment in medical and pharmacy benefits during the 29-day follow-up period 2) Died on the index date will be excluded 3) At least 1 claim for a non-index mAb and antiviral, including the tixagevimab co-packaged with cilgavimab during the 12-month baseline period or on index date and in the outpatient setting during the 29-day follow-up period 4) This exclusion criterion will not be applied to the prophylaxis cohort, instead for the prophylaxis cohort a post-index claim for another mAb or antiviral treatment will be deemed proxy for treatment failure and is therefore an endpoint of interest 5) Hospitalized or receiving critical care (intubation or mechanical ventilation, extracorporeal membrane oxygenation (ECMO), 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

    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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