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

NCT04409509 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-01-24

Study results available
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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

  • Coronavirus Disease 2019 (COVID-19)

Interventions

BIOLOGICAL

Garadacimab, Factor XIIa Antagonist Monoclonal Antibody

Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously

DRUG

Placebo

CSL312 diluent administered intravenously

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-01-12
Completion
2021-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409509 on ClinicalTrials.gov