Investigating otilimab in patients with severe pulmonary COVID-19 related disease

Not Applicable

• Conditions: -J128 Other viral pneumonia; Other viral pneumonia; J128

• Registration Number: PER-042-20
• Lead Sponsor: GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-21
• Study Completion: 2021-01-10
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1)Age ≥18 years and ≤79 years
2)Have positive SARS-CoV-2 result
3)Be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan)
4)Be developing new onset of oxygenation impairment requiring any of the following: high-flow oxygen (≥15L/min); non-invasive ventilation (e.g. CPAP, iPAP); mechanical ventilation ≤48h prior to dose
5)Have increased biological markers of systemic inflammation.
6)No gender restriction
7)Female participants must meet and agree to abide by the contraceptive criteria.
8)Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures.

For more details check the protocol

Exclusion Criteria

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.
2)Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU
3)Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor
4)Current serious or uncontrolled medical condition or abnormality of clinical
5)Untreated systemic bacterial, fungal, viral, or other infection
6)Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB
7)Known HIV regardless of immunological status
8)Known HBsAg and/or anti-HCV positive
9)Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy
10)Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization
11)Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization
12)History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy
For more details check the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified