1. Currently enrolled, planning to enroll, or participated, within the
2. Pregnant or breastfeeding (female subjects)
3. Intubated or requires mechanical ventilation (including ECMO)
4. In the opinion of the investigator, the subject is expected to be
5. Active Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR)
6. In the opinion of the investigator, the subject is not expected to
7. Any of the following comorbid conditions prior to
randomization and prior to SARS-CoV-2 infection:
• Severe heart failure (New York Heart Association Class IV)
• End-stage renal disease (Stage ≥ 4) or need for renal
replacement therapy
• Biopsy-confirmed cirrhosis, portal hypertension, or hepatic
encephalopathy
• Malignancy (Stage IV)
• Chronic lung disease requiring the use of oxygen at home
• Active tuberculosis disease
8. Active bleeding or current clinically significant coagulopathy
(eg, international normalized ratio [INR] > 1.5) or clinically
significant risk for bleeding (eg, recent intracranial hemorrhage
or bleeding peptic ulcer within the last 4 weeks)
9. History of venous thrombosis, myocardial infarction, or
cerebrovascular event within the last 3 months, or a
prothrombotic disorder (eg, antithrombin III, protein C, or
protein S deficiency)
10. Known or suspected Grade 3 or 4 infusion-related reaction or
hypersensitivity (per Common Terminology Criteria for Adverse
Events) to monoclonal antibody therapy, or hypersensitivity to
the IP or any excipients of the IP [National Cancer Institute,
2009]
11. Currently receiving a therapy not permitted during the study
12. Female subject of childbearing potential or fertile male subject
either not using or not willing to use an acceptable method of
contraception to avoid pregnancy during the study and for
30 days after administration of IP
13. Any clinical or laboratory abnormality or other underlying
conditions (eg, psychological disorders, substance abuse) that
would render the subject unsuitable for participation in the study,
in the opinion of the investigator