Last updated: 06/30/2025 11:40:27
Systematic Literature Review (SLR) and Indirect Treatment Comparison (ITC) of VIR-7831 for Coronavirus Disease 2019 (COVID-19)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Systematic Literature Review and Indirect Treatment Comparison of VIR-7831 in Early Treatment of Non-hospitalized Patients with COVID-19
Trial description: The aim of the study is to conduct a SLR and ITC to evaluate the efficacy and safety and to assess the comparative effectiveness of VIR-7831 and other COVID-19 therapeutic agents as early treatment of non-hospitalized participants with mild or moderate COVID-19.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with progression of COVID-19 as defined by hospitalization >24 hours for acute management of illness or death
Timeframe: Up to 60 days
Percentage of participants with progression of COVID-19 as defined by visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death
Timeframe: Up to 60 days
Number of medical visits of participants associated with COVID-19
Timeframe: Up to 60 days
Percentage of participants who progress to develop severe and/or critical respiratory COVID-19 as defined by requirement for and method of supplemental oxygen
Timeframe: Up to 60 days
Percentage of deceased participants due to all causes
Timeframe: Up to 60 days
Time to final hospital discharge
Timeframe: Up to 60 days
Time to final hospital discharge or death of participants
Timeframe: Up to 60 days
Total intensive care unit length of stay of participants
Timeframe: Up to 60 days
Total number of ventilator days of participants
Timeframe: Up to 60 days
Percentage of participants hospitalized due to non-respiratory complications of COVID-19
Timeframe: Up to 60 days
Mean change in symptom score of participants assessed using InFLUenza Patient-reported outcome (FLU-PRO) Plus Questionnaire or Total Symptom Questionnaire
Timeframe: Up to 60 days
Time to symptom alleviation/resolution of participants using FLU-PRO Plus
Timeframe: Up to 60 days
Percentage of participants with symptom alleviation or resolution using FLU-PRO Plus
Timeframe: Up to 60 days
Change from Baseline in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load
Timeframe: Baseline and up to 60 days
Change from Baseline in health-related quality of life
Timeframe: Baseline and up to 60 days
Change from Baseline in work productivity and activity impairment
Timeframe: Baseline and up to 60 days
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) or adverse events of special interest (AESIs)
Timeframe: Up to 60 days
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-28-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Virus Diseases, COVID-19
Product
sotrovimab
Collaborators
Not applicable
Study date(s)
March 2021 to February 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Participants >=12 years of age.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Participants >=12 years of age.
- Mild or moderate COVID-19 illness requiring ambulatory care (i.e., non-hospitalized).
- Positive SARS-CoV-2 result (any validated test). Exclusion Criteria:
- Participants <12 years of age
- Not in ambulatory care for COVID-19
- Negative SARS-CoV-2 test
- Currently hospitalized
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
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
2022-28-02
Actual study completion date
2022-28-02
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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