A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease (study 214094)

Phase 2

Completed

• Conditions: COVID-19 related lung disease; coronavirus related lung disease; 10047438; 10024970

• Registration Number: NL-OMON55089
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-12-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

PART 1
- Males and Females >= 18 and <=79 years old
- Positive SARS-CoV-2 result AND
Hospitalized due to diagnosis of pneumonia AND
Developing new onset of oxygenation impairment AND
Increased biological biomakers
- Female participant of childbearing potential who agrees to follow the
contraceptive guidance in appendix 4 of the protocol during the study
intervention period and for at least 60 days after the last dose of study
intervention.
See protocol section 5.1; page 26 and 27 for details.

PART 2
- Males and Females >= 70 years old
- Positive SARS-CoV-2 result AND
Hospitalized due to diagnosis of pneumonia AND
Developing new onset of oxygenation impairment AND
Increased biological biomakers
See protocol section 5.1; page 26 and 27 for details.

Exclusion Criteria

Part 1
- Progression to death is imminent and inevitable within the next 48 hours,
irrespective of the provision of treatments, in the opinion of the investigator.
- Multiple organ failure according to the investigator*s judgement or a
Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
- Extracorporeal membrane oxygenation (ECMO) or hemofiltration/dialysis, or
high-dose (>0.15*g/kg/min) noradrenaline (or equivalent) or more than one
vasopressor.
- Current serious or uncontrolled medical condition
- Untreated infection (other than SARS-Cov-2)
- Known Positive TB, HIV, hepatitis B or C test
- Received monoclonal antibody therapy within the past 3 months prior to
randomization
- Received immunosuppressant therapy
- History of allergic reaction
- Currently receiving chronic oral corticosteroids higher than prednisone 10 mg
or equivalent per day.
- Treatment with an investigational drug within 30 days of randomization
- Participating in other drug clinical trials, including for COVID-19
- Pregnancy or breastfeeding
See protocol section 5.2; page 28 and 29 for details

Part 2
- Progression to death is imminent and inevitable within the next 48 hours,
irrespective of the provision of treatments, in the opinion of the investigator.
- Multiple organ failure according to the investigator*s judgement or a
Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
- Extracorporeal membrane oxygenation (ECMO) or hemofiltration/dialysis, or
more than one inotrope/vasopressor of any class.
- Current serious or uncontrolled medical condition
- Untreated infection (other than SARS-Cov-2)
- Known Positive TB, HIV, hepatitis B or C test
- Received monoclonal antibody therapy within the past 3 months prior to
randomization
- Received immunosuppressant therapy
- History of allergic reaction
- Currently receiving chronic oral corticosteroids higher than prednisone 10 mg
or equivalent per day.
- Treatment with an investigational drug within 30 days of randomization
- Participating in other drug clinical trials, including for COVID-19
See protocol section 5.2; page 28 and 29 for details

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Participants alive and free of respiratory failure at Day 28</p><br>