Overview

This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (COVID 19)

Eligibility

Inclusion Criteria:

• Age 18 years
• Positive for SARS CoV 2 infection confirmed by a clinically acceptable test
• Chest CT scan or X ray results confirming interstitial pneumonia
• At least 1 of the following:
• Respiratory frequency > 30 breaths per minute
• SpO2 93% on room air
• Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300
• SpO2/FiO2) ratio < 218 (if PaO2/FiO2 ratio is not available)
• Radiographic lung infiltrates > 50%

Exclusion Criteria:

• Currently enrolled, planning to enroll, or participated, within the last 30 days, in a clinical study requiring administration of an IMP, including expanded access or compassionate use
• Pregnant or breastfeeding (female subjects)
• Intubated and require mechanical ventilation (including ECMO) at the time of randomization
• In the opinion of the investigator, the subject is expected to be intubated in the first 24 hours after IMP administration
• Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order
• In the opinion of the investigator, not expected to survive for > 48 hours after admission
• Presence of 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
• Active bleeding or a 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)
• History of venous thrombosis, myocardial infarction or cerebrovascular event within 3 months, or a prothrombotic disorder (eg, antithrombin III, protein C or protein S deficiency)
• Known or suspected Grade 3 or 4 infusion-related reaction or hypersensitivity (per Common Terminology Criteria for Adverse Events [CTCAE]) to monoclonal antibody therapy, or hypersensitivity to the IMP or any excipients of the IMP
• Currently receiving a therapy not permitted during the study.
• 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 receipt of the last dose of IMP
• 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