Last updated: 01/30/2025 04:40:26

Real-world effectiveness of Sotrovimab in non-hospitalized individuals with Coronavirus Disease 2019 (COVID-19)

GSK study ID
219020
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 Sotrovimab in Early Treatment of Non-Hospitalized Patients with COVID-19 in the United States
Trial description: This is a retrospective, observational study for the treatment of COVID-19 in participants with mild to moderate symptoms at risk for progression to hospitalization or death. This study will not have direct participants contact or primary collection of individual human subject data. The participants data will be collected from the National Center for Advancing Translational Science (NCATS) National COVID Cohort Collaborative (N3C) database.
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 (all-cause related)

Timeframe: Up to Day 29

Secondary outcomes:

Number of participants hospitalized due to COVID-19

Timeframe: Up to Day 29

Number of participants with an ER visit (all-cause related)

Timeframe: Up to Day 29

Number of participants with an ER visit (COVID-19 related)

Timeframe: Up to Day 29

Number of participants with an evidence of critical care due to any cause

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, Priyanka Bobbili, Raj Desai, Daniel C Gibbons, Myriam Drysdale, Maral DerSarkissian, Vishal Patel, Helen J Birch, Emily J Lloyd, Adina Zhang, Mei Sheng Duh, . Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the US National COVID Cohort Collaborative (N3C). Clinical drug investigation. 2024-Feb-20 DOI: 10.1007/s40261-024-01344-4 PMID: 38379107
    Medical condition
    Severe Acute Respiratory Syndrome, COVID-19
    Product
    sotrovimab
    Collaborators
    Not applicable
    Study date(s)
    June 2022 to April 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Age greater than or equal to (≥) 12 years
    • Confirmed COVID-19 by reverse transcriptase (RT)-PCR or rapid antigen test or date of diagnosis of U07.1 (COVID-19, virus identified) between 26 May 2021 to most recently available data; patient’s first confirmed diagnosis during the study period will be included
    • Previously administered a mAb (e.g., bamlanivimab, bamlanivimabetesevimab,casirivimab-imdevimab, bebtelovimab), antiviral (paxlovid,molnupiravir, or remdesivir), or Evusheld 12 months prior to the treatment date
    • Administered a mAb (bamlanivimab, bamlanivimab-etesevimab, casirivimabimdevimab,bebtelovimab, Sotrovimab) or antiviral (paxlovid, molnupiravir, or remdesivir), or Evusheld in a non-hospitalized setting (i.e., in an outpatient or ER setting) during the acute observation period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Age greater than or equal to (≥) 12 years
    • Confirmed COVID-19 by reverse transcriptase (RT)-PCR or rapid antigen test or date of diagnosis of U07.1 (COVID-19, virus identified) between 26 May 2021 to most recently available data; patient’s first confirmed diagnosis during the study period will be included
    • 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 observation period
    Exclusion criteria:
    • Previously administered a mAb (e.g., bamlanivimab, bamlanivimabetesevimab,casirivimab-imdevimab, bebtelovimab), antiviral (paxlovid,molnupiravir, or remdesivir), or Evusheld 12 months prior to the treatment date
    • Administered a mAb (bamlanivimab, bamlanivimab-etesevimab, casirivimabimdevimab,bebtelovimab, Sotrovimab) or antiviral (paxlovid, molnupiravir, or remdesivir), or Evusheld in a non-hospitalized setting (i.e., in an outpatient or ER setting) during the acute observation period
    • Administered Sotrovimab >10 days after COVID-19 diagnosis date
    • Hospitalized, or receiving critical care (intubation or mechanical ventilation, 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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