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

Inclusion criteria for Part 1:

• Participants aged >=18 years and =15L/min)
• non-invasive ventilation (for example. CPAP, BIPAP)
• mechanical ventilation upper limit of normal [ULN] or serum ferritin >ULN).
• No gender restriction.
• Female participants must meet and agree to abide by the contraceptive criteria detailed in the protocol. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding or if she is using highly effective contraceptive methods. Women of non-childbearing potential can also participate. A negative highly sensitive pregnancy test at hospital admission or before the first dose of study intervention.
• Capable of giving written informed consent.

Inclusion Criteria for Part 2:

• Participants aged 70 years or above at the time of obtaining informed consent.
• Participants must:
• have positive SARS-CoV-2 result (any validated test, for example. RT-PCR [performed on an appropriate specimen; for example. respiratory tract sample])
• and be hospitalized due to diagnosis of pneumonia (chest X-ray or CT scan consistent with COVID-19).
• and be developing new onset of oxygenation impairment requiring any of the following:
• high-flow oxygen (>=15L/min)
• non-invasive ventilation (for example. CPAP, BiPAP)
• mechanical ventilation ULN or serum ferritin >ULN.
• No gender restriction.
• Capable of giving written informed consent.

Exclusion Criteria for 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) hemofiltration/dialysis or high-dose (>0.15 micrograms [mcg]/kilograms [kg]/min) noradrenaline (or equivalent) or more than one vasopressor.
• Current serious or uncontrolled medical condition (for example: significant pulmonary disease [such as severe chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis], heart failure [New York Heart Association {NYHA} class III or higher], renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
• Untreated systemic bacterial, fungal, viral, or other infection (other than SARS-CoV-2).
• Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
• Known Human Immunodeficiency Virus (HIV) regardless of immunological status.
• Known hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV) positive.
• Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
• Received monoclonal antibody therapy (for examplee. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received, during the study.
• Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, Janus Kinase (JAK) inhibitors (for examplee. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study.
• History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy.
• Received COVID-19 convalescent plasma within 48 hours of randomization.
• Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 milligrams (mg) or equivalent per day.
• Treatment with an investigational drug within 30 days of randomizati