A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL312 in Coronavirus Disease 2019 (COVID-19)

About this Study

A study to assess the safety and efficacy of CSL312 (immunoglobulin G4 (IgG4)/lambda, FXIIa antagonist, recombinant monoclonal antibody) administered intravenously, in combination with standard of care treatment, in patients with COVID-19.

Sponsor Protocol ID:Pending
IRB Number:Pending
Closed for Enrollment
Interventional
Phase 2
June 22, 2020
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria
Inclusion criteria:

1. Capable of providing written informed consent. An individual
legally permitted to make medical decisions on the subject’s
behalf can provide written informed consent.

2. Willing and able to adhere to all protocol requirements

3. Age ≥ 18 years at the time that informed consent is obtained

4. Positive for Severe acute respiratory syndrome coronavirus-2
(SARS-CoV-2) infection confirmed by a clinically acceptable
test

5. Chest computed tomography (CT) scan or X-ray results
confirming interstitial pneumonia

6. At least 1 of the following:
• Respiratory frequency > 30 breaths per minute
• Saturation of peripheral (capillary) oxygen (SpO2) ≤ 93% on
room air
• Ratio of arterial partial pressure of oxygen to fraction of
inspired oxygen (PaO2/FiO2)
• SpO2/FiO2 ratio
• Radiographic lung infiltrates > 50%

Exclusion Criteria
1. Currently enrolled, planning to enroll, or participated, within the
last 30 days, in a clinical study requiring administration of an
investigational product (IP), including expanded access or
compassionate use

2. Pregnant or breastfeeding (female subjects)
3. Intubated or requires mechanical ventilation (including ECMO)
at the time of randomization

4. In the opinion of the investigator, the subject is expected to be
intubated within the first 24 hours after IP administration

5. Active Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR)
order

6. In the opinion of the investigator, the subject is not expected to
survive for > 48 hours

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

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Heather Vaughn
Phone Number: 601-815-8724
Email: hvaughn@umc.edu
Principal Investigator:Marshall, Gailen D, M.D.Ph.D., M.D., Ph.D.
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