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Monoclonal Antibodies

Part 1: Participants receiving otilimab for Coronavirus (OSCAR Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 60
Awards & highlights

OSCAR Trial Summary

This trial is studying whether a drug called otilimab can help treat people who have severe lung problems from COVID-19 and need extra oxygen or mechanical ventilation. People in the study will get either otilimab or a placebo, in addition to their regular care.

Eligible Conditions
  • Coronavirus

OSCAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Percentage of Participants Alive and Free of Respiratory Failure at Day 28
Part 2: Percentage of Participants Alive and Free of Respiratory Failure at Day 28
Secondary outcome measures
Part 1: Number of Participants Who Died Due to All Causes at Day 60
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events (Non-SAEs)
Part 1: Percentage of Participants Admitted to Intensive Care Unit (ICU) up to Day 28
+33 more

OSCAR Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Participants receiving otilimabExperimental Treatment2 Interventions
Participants (age 70 years or above) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 2.
Group II: Part 1: Participants receiving otilimabExperimental Treatment2 Interventions
Participants (age >=18 years and <=79 years) will receive a single dose of otilimab administered as an IV infusion in addition to standard of care in Part 1.
Group III: Part 2: Participants receiving placebo 2Placebo Group2 Interventions
Participants (age 70 years or above) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 2.
Group IV: Part 1: Participants receiving placebo 1Placebo Group2 Interventions
Participants (age >=18 years and <=79 years) will receive a single dose of matching placebo administered as an IV infusion in addition to standard of care in Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Otilimab
2020
Completed Phase 2
~1160
Standard of care
2019
Completed Phase 4
~15850

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,763 Previous Clinical Trials
8,103,611 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,143,183 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease
2020. "Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04376684.
~235 spots leftby May 2025
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