Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
A Phase 2, Multicenter, Double Blind, Randomized, Placebo-Controlled Study to Evaluate CSL312 in Coronavirus Disease 2019 (COVID 19)
1 other identifier
interventional
124
1 country
14
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2021
CompletedResults Posted
Study results publicly available
January 24, 2022
CompletedJanuary 24, 2022
January 1, 2022
7 months
May 28, 2020
December 23, 2021
January 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percent of Participants With Tracheal Intubation or Death Prior to Tracheal Intubation
From randomization to Day 28
Secondary Outcomes (24)
Percent of Participants With Death From All Causes
From randomization to Day 28
Percent of Participants With Tracheal Intubation
From randomization to Day 28
Number of Participants With ≥ 2-Point Improvement Compared to Baseline on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
From randomization to Day 28
Percent of Participants With ≥ 2-Point Improvement Compared to Baseline on NIAID
From randomization to Day 28
Number of Participants Within Each of the Categories of the NIAID at End of Study
Day 28
- +19 more secondary outcomes
Study Arms (2)
CSL312
EXPERIMENTALGaradacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Placebo
PLACEBO COMPARATORCSL312 diluent administered intravenously
Interventions
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Positive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined using a molecular diagnostic test (reverse transcription polymerase chain reaction \[RT-PCR\] or equivalent) approved by regulatory authorities (including Food and Drug Administration or Brazilian Health Regulatory Agency) or allowed under an emergency use authorization within 14 days before Screening. If a false negative result is suspected, the SARS-CoV-2 test may be repeated within the Screening Period.
- Chest CT scan or X ray results confirming interstitial pneumonia
- Severe COVID 19 disease as evidenced by ≥ 1 of the following criteria at Screening including within 24 hours before Screening:
- Respiratory frequency \> 30 breaths per minute
- SpO2 ≤ 93% on room air
- Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) \< 300
- Ratio of Arterial oxygen saturation to fraction of inspired oxygen (SaO2/FiO2 ratio) \< 218 (if PaO2/FiO2 ratio is not available)
- Radiographic lung infiltrates \> 50%
You may not qualify if:
- Currently enrolled, planning to enroll, or participated, within the last 30 days, in a clinical study requiring administration of an IP, including expanded access or compassionate use with the only exception being administration of convalescent plasma. Administration of IP is permitted only if an emergency use authorization has been granted (eg, remdesivir). Additionally, off label use of approved drugs (eg, anti IL 6/anti IL 6R) is also permitted.
- 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)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (14)
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
Theia Clinical Research, LLC
St. Petersburg, Florida, 33707, United States
MercyOne North Iowa Medical Center
Mason City, Iowa, 50401, United States
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, 50702, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Inspira Health Center Vineland
Vineland, New Jersey, 08360, United States
Sisters of Charity Hospital/ St. Joseph's Campus
Buffalo, New York, 14225, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
PharmaTex Research
Amarillo, Texas, 79109, United States
UT Health Science Center, McGovern Medical School
Houston, Texas, 77030, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Related Publications (1)
Papi A, Stapleton RD, Shore PM, Bica MA, Chen Y, Larbig M, Welte T. Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19. Lung. 2023 Apr;201(2):159-170. doi: 10.1007/s00408-023-00615-9. Epub 2023 Mar 31.
PMID: 37000214DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- CSL Behring
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 1, 2020
Study Start
July 1, 2020
Primary Completion
January 12, 2021
Study Completion
January 12, 2021
Last Updated
January 24, 2022
Results First Posted
January 24, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
- Access Criteria
- Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.