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Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
NCT04409509 · View on ClinicalTrials.gov ↗
Study 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)
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Garadacimab, Factor XIIa Antagonist Monoclonal Antibody
Study Locations (14)
Florida
- Nova Clinical Research, LLC — Bradenton
- Theia Clinical Research, LLC — St. Petersburg
Iowa
- MercyOne North Iowa Medical Center — Mason City
- Northeast Iowa Medical Education Foundation — Waterloo
New Jersey
- Holy Name Hospital — Teaneck
- Inspira Health Center Vineland — Vineland
Texas
- PharmaTex Research — Amarillo
- UT Health Science Center, McGovern Medical School — Houston
Massachusetts
- Lahey Hospital and Medical Center — Burlington
Mississippi
- University of Mississippi Medical Center — Jackson
New York
- Sisters of Charity Hospital/ St. Joseph's Campus — Buffalo
North Carolina
- Carolina Institute for Clinical Research — Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2021-01-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04409509
The ClinicalTrials.gov registry entry for NCT04409509 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronavirus Disease 2019 (COVID-19) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04409509 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Florida, Iowa, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04409509 about?
NCT04409509 is a clinical study titled "Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)". 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)
What is the current status of trial NCT04409509?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2020-07-01. Estimated completion is 2021-01-12.
What conditions does trial NCT04409509 study?
This clinical trial studies the following conditions: Coronavirus Disease 2019 (COVID-19). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04409509?
The interventions under investigation include: Placebo (DRUG), Garadacimab, Factor XIIa Antagonist Monoclonal Antibody (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04409509?
This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04409509 being conducted?
This trial has 14 study locations across Florida, Iowa, Massachusetts, Mississippi, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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