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Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease

NCT04376684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1156

Last updated 2024-09-23

Study results available
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Summary

OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to \[\<=\] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.

Conditions

  • Severe Acute Respiratory Syndrome

Interventions

BIOLOGICAL

Otilimab

Otilimab will be administered once via IV route.

BIOLOGICAL

Placebo 1

Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.

BIOLOGICAL

Placebo 2

Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route.

DRUG

Standard of care

All participants will receive standard of care as per institutional protocol.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2021-07-15
Completion
2021-08-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • France
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Russia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376684 on ClinicalTrials.gov