Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease (OSCAR)
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ClinicalTrials.gov Identifier: NCT04376684 |
Recruitment Status :
Completed
First Posted : May 6, 2020
Results First Posted : March 9, 2022
Last Update Posted : March 23, 2022
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Severe Acute Respiratory Syndrome |
Interventions |
Biological: Otilimab Biological: Placebo 1 Biological: Placebo 2 Drug: Standard of care |
Enrollment | 1156 |
Participant Flow
Recruitment Details | This was a 2-part study evaluating efficacy and safety of intravenously (IV) administered otilimab in participants with severe pulmonary Coronavirus Disease-2019 (COVID-19) related disease. Part 1 consisted of participants aged 18 to 79 years and Part 2 consisted of participants aged 70 years and older. |
Pre-assignment Details | A total of 1156 (806 in Part 1 and 350 in Part 2) participants were enrolled in the study (Enrolled Population: All participants who entered the study). |
Arm/Group Title | Part 1: Placebo 1 | Part 1: Otilimab 90 mg | Part 2: Placebo 2 | Part 2: Otilimab 90 mg |
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Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent [%] weight by volume [w/v] sodium chloride solution) once along with standard of care. | Participants between the ages of >=18 years and <=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care. | Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care. | Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care. |
Period Title: Part 1 (Up to Day 60) | ||||
Started | 403 | 403 | 0 | 0 |
Completed | 388 | 379 | 0 | 0 |
Not Completed | 15 | 24 | 0 | 0 |
Reason Not Completed | ||||
Withdrawal by Subject | 7 | 8 | 0 | 0 |
Protocol Violation | 2 | 3 | 0 | 0 |
Physician Decision | 2 | 5 | 0 | 0 |
Lost to Follow-up | 4 | 8 | 0 | 0 |
Period Title: Part 2 (Up to Day 60) | ||||
Started | 0 | 0 | 175 | 175 |
Completed | 0 | 0 | 170 | 171 |
Not Completed | 0 | 0 | 5 | 4 |
Reason Not Completed | ||||
Withdrawal by Subject | 0 | 0 | 1 | 1 |
Physician Decision | 0 | 0 | 1 | 1 |
Lost to Follow-up | 0 | 0 | 3 | 2 |
Baseline Characteristics
Arm/Group Title | Part 1: Placebo 1 | Part 1: Otilimab 90 mg | Part 2: Placebo 2 | Part 2: Otilimab 90 mg | Total | |
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Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)79 years received blinded 1-hour IV infusion of placebo (sterile 0.9 percent [%] weight by volume [w/v] sodium chloride solution) once along with standard of care. | Participants between the ages of >=18 years and <=79 years received blinded otilimab 90 milligrams (mg) (solution in single-use vial diluted in sterile 0.9% w/v sodium chloride solution) once as 1-hour IV infusion along with standard of care. | Participants aged 70 years or above received blinded 1-hour IV infusion of placebo (sterile 5% w/v dextrose solution) once along with standard of care. | Participants aged 70 years or above received blinded otilimab 90 mg (solution in single-use vial diluted in sterile 5% dextrose solution) once as 1-hour IV infusion along with standard of care. | Total of all reporting groups | |
Overall Number of Baseline Participants | 403 | 403 | 175 | 175 | 1156 | |
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Baseline characteristics were presented for Enrolled Population.
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 403 participants | 403 participants | 175 participants | 175 participants | 1156 participants | |
<18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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Between 18 to 64 years |
249 61.8%
|
250 62.0%
|
0 0.0%
|
0 0.0%
|
499 43.2%
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|
>=65 to 84 years |
154 38.2%
|
153 38.0%
|
168 96.0%
|
168 96.0%
|
643 55.6%
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>=85 years |
0 0.0%
|
0 0.0%
|
7 4.0%
|
7 4.0%
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14 1.2%
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 403 participants | 403 participants | 175 participants | 175 participants | 1156 participants | |
Female |
128 31.8%
|
101 25.1%
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75 42.9%
|
73 41.7%
|
377 32.6%
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Male |
275 68.2%
|
302 74.9%
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100 57.1%
|
102 58.3%
|
779 67.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 403 participants | 403 participants | 175 participants | 175 participants | 1156 participants | |
American Indian or Alaska Native |
24 6.0%
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30 7.4%
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3 1.7%
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8 4.6%
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65 5.6%
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Asian - Central/South Asian Heritage |
42 10.4%
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31 7.7%
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1 0.6%
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0 0.0%
|
74 6.4%
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Asian - East Asian Heritage |
4 1.0%
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4 1.0%
|
0 0.0%
|
0 0.0%
|
8 0.7%
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Asian - Japanese Heritage |
15 3.7%
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14 3.5%
|
13 7.4%
|
5 2.9%
|
47 4.1%
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Asian - South East Asian Heritage |
12 3.0%
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8 2.0%
|
1 0.6%
|
0 0.0%
|
21 1.8%
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Black or African American |
25 6.2%
|
26 6.5%
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6 3.4%
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6 3.4%
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63 5.4%
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White - Arabic/North African Heritage |
27 6.7%
|
21 5.2%
|
14 8.0%
|
21 12.0%
|
83 7.2%
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White - White/Caucasian/European Heritage |
235 58.3%
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251 62.3%
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136 77.7%
|
134 76.6%
|
756 65.4%
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Mixed Asian Race |
0 0.0%
|
1 0.2%
|
0 0.0%
|
0 0.0%
|
1 0.1%
|
|
Mixed White Race |
1 0.2%
|
1 0.2%
|
1 0.6%
|
0 0.0%
|
3 0.3%
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Multiple |
7 1.7%
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7 1.7%
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0 0.0%
|
0 0.0%
|
14 1.2%
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Unknown |
11 2.7%
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9 2.2%
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0 0.0%
|
1 0.6%
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21 1.8%
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Outcome Measures
Adverse Events