Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID 19)

STATUS

Recruiting
participants needed

124
sponsor

CSL Behring

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Updated on 19 February 2024

See if I qualify

ct scan

pao2

FIO2

monoclonal antibodies

pneumonia

PCR test

oximetry

pao2/fio2 ratio

covid-19

SARS

chest ct

coronavirus infection

administered intravenously

molecular diagnostic

fraction of inspired oxygen (fio2)

acute respiratory syndrome (sars)

Summary

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)

Details

Condition	Coronavirus Disease 2019
Age	18years - 100years
Treatment	Placebo, Garadacimab, Factor XIIa Antagonist Monoclonal Antibody
Clinical Study Identifier	NCT04409509
Sponsor	CSL Behring
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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acute respiratory syndrome (sars)

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Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID 19)