Last updated: 12/29/2021 08:40:12
Systemic literature review and indirect treatment comparison of Otilimab for Coronavirus Disease 2019 (COVID-19)
GSK study ID
214537
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Systematic Literature Review and Indirect Treatment Comparison of Otilimab for Hospitalized Patients with Severe Pulmonary COVID-19 related Disease
Trial description: The aim of this observational study is to conduct a systematic literature review (SLR) and indirect treatment comparison (ITC) to assess the comparative effectiveness of Otilimab to other competitor products among hospitalized participants with severe pulmonary COVID-19 related disease.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants alive and free of respiratory failure
Timeframe: Up to 60 days
Percentage of participants recovered from respiratory failure
Timeframe: Up to 60 days
Percentage of deceased participants due to all causes
Timeframe: Up to 60 days
Percentage of participants alive and independent of supplementary oxygen
Timeframe: Up to 60 days
Percentage of participants admitted to the intensive care unit (ICU)
Timeframe: Up to 60 days
Time to final ICU discharge
Timeframe: Up to 60 days
Time to final hospital discharge
Timeframe: Up to 60 days
Time to number of deaths due to all causes
Timeframe: Up to 60 days
Time to recovery from respiratory failure
Timeframe: Up to 60 days
Time to last dependence on supplementary oxygen
Timeframe: Up to 60 days
Percentage of participants with adverse events (AEs)/serious adverse events (SAEs)
Timeframe: Up to 60 days
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-23-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
COVID-19
Product
Otilimab
Collaborators
NA
Study date(s)
March 2021 to August 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 Years - NA
Accepts healthy volunteers
No
- Adult participants greater than or equal to (>=)18 years of age
- Positive SARS-CoV-2 result (any validated test)
- Participants less than (<) 18 years of age
- Negative SARS-CoV-2 test
Inclusion and exclusion criteria
Inclusion criteria:
- Adult participants greater than or equal to (>=)18 years of age
- Positive SARS-CoV-2 result (any validated test)
- Hospitalized due to COVID-19 illness
- Developing new onset of oxygenation impairment requiring respiratory support (including, but not limited to, high flow oxygen, non-invasive ventilation, or mechanical ventilation).
Exclusion criteria:
- Participants less than (<) 18 years of age
- Negative SARS-CoV-2 test
- Not hospitalized due to COVID-19 illness.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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