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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

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
Paediatric Inflammatory Multisystem Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 60

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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

2020

Completed Phase 4

~17710