Last updated: 05/05/2025 06:20:22

Real-world evidence (RWE) on impact of sotrovimab of long Coronavirus Disease (COVID)

GSK study ID
218554
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: The Impact of Early Treatment of COVID-19 with Sotrovimab on Post-Acute COVID-19 Syndrome: An Analysis of National COVID Cohort Collaborative (N3C) Data
Trial description: This study will evaluate the impact of sotrovimab compared to untreated high-risk participants as well as the impact of being high-risk versus non-high-risk for severe COVID-19 on post-acute sequelae of COVID-19 (PASC) using the United States N3C data.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Phase 1- Number of participants meeting each PASC definition

Timeframe: Up to 2 years

Phase 2- Number of high-risk participants with PASC comparing Cohort 1 vs Cohort 2a

Timeframe: Up to 2 years

Secondary outcomes:

Number of participants with Baseline Demographics in all 3 cohorts

Timeframe: Up to 2 years

Number of participants with Clinical Characteristics in all 3 cohorts

Timeframe: Up to 2 years

Number of participants with PASC risk in untreated high-risk patients (Cohort 2b) and untreated non-high-risk patients (Cohort 3)

Timeframe: Up to 2 years

Interventions:
Not applicable
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2024-13-02
Time perspective:
Retrospective
Clinical publications:
Myriam Drysdale, Rose Chang, Tracy Guo, Mei Sheng Duh, Jennifer Han, Helen Birch, Catherine Sharpe, Daisy Liu, Sarah Kalia, Melissa Van Dyke, Maral DerSarkissian, Iain A Gillespie. Impact of treatment of COVID-19 with sotrovimab on post-acute sequelae of COVID-19 (PASC): an analysis of National COVID Cohort Collaborative (N3C) data. Infection. 2025-Mar-22; doi:10.1007/s15010-025-02505-z https://link.springer.com/article/10.1007/s15010-025-02505-z PMID: 40120069 DOI: 10.1007/s15010-025-02505-z
Medical condition
Severe Acute Respiratory Syndrome, COVID-19
Product
sotrovimab
Collaborators
Not applicable
Study date(s)
April 2023 to February 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Participants with confirmed COVID-19 by polymerase chain reaction or antigen test or presence of diagnostic code U07.1 (COVID-19, virus identified)
  • COVID-19 diagnosis must occur between 26-May-2021 and 26-March-2022 (to allow for the Food and Drug Administration -authorized treatment of sotrovimab among participants in Cohort 1 within 10 days of COVID-19 diagnosis. This time window will be applied to Cohort 2a for the comparison of Cohorts 1 and 2a. However, for the comparison of Cohorts 2b and 3, the index window will be lengthened to include all participants diagnosed from 01-March-2020 to the date of most recent data availability.
  • Previously administered Monoclonal antibody (example, bamlanivimab, bamlanivimab-etesevimab, casirivimab-imdevimab, bebtelovimab, sotrovimab), antiviral (example, paxlovid, molnupiravir, or remdesivir), or Evusheld during the Baseline period.
  • For Cohort 1 and Cohort 2a only, not hospitalized during the Baseline period (COVID-19 diagnosis and index date).
Inclusion and exclusion criteria
Inclusion criteria:

    Participants with confirmed COVID-19 by polymerase chain reaction or antigen test or presence of diagnostic code U07.1 (COVID-19, virus identified)

    • COVID-19 diagnosis must occur between 26-May-2021 and 26-March-2022 (to allow for the Food and Drug Administration -authorized treatment of sotrovimab among participants in Cohort 1 within 10 days of COVID-19 diagnosis. This time window will be applied to Cohort 2a for the comparison of Cohorts 1 and 2a. However, for the comparison of Cohorts 2b and 3, the index window will be lengthened to include all participants diagnosed from 01-March-2020 to the date of most recent data availability.
    • Only the first COVID-19 diagnosis for each participant will be considered, in case of multiple COVID-19 infections per participant
    • Participants age greater than or equal (≥) 12 years on the index date
    • Sufficient data to allow at least 12-months of Baseline period prior to the index date
    • Survival and continuous follow-up through the acute phase
Exclusion criteria:

    Previously administered Monoclonal antibody (example, bamlanivimab, bamlanivimab-etesevimab, casirivimab-imdevimab, bebtelovimab, sotrovimab), antiviral (example, paxlovid, molnupiravir, or remdesivir), or Evusheld during the Baseline period.

    • For Cohort 1 and Cohort 2a only, not hospitalized during the Baseline period (COVID-19 diagnosis and index date).
    • Re-infection with COVID-19 during the acute phase (i.e., a second positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR/antigen test at least 45 days after COVID-19 diagnosis and after at least 1 negative SARS-CoV-2 PCR/antigen test).
    • For Cohort 1 only, additional sotrovimab administration ≥ 2 days after index date during the acute phase.

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
2024-13-02
Actual study completion date
2024-13-02

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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