Trials / Withdrawn
WithdrawnNCT04519424
CSL324 in COVID-19
A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate CSL324 in Coronavirus Disease 2019 (COVID-19)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with SOC treatment, in subjects with COVID 19. For the purposes of this study, standard of care (SOC) may include any written or established treatment protocol followed at the study site for the treatment of severe COVID-19 or its complications, including off-label use of marketed pharmaceutical products and / or products with emergency use authorization granted for the treatment of COVID-19 (ie, not yet marketed) (eg, remdesivir).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL324 | Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
| DRUG | Placebo | Normal saline (0.9% sodium chloride) |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-04-01
- Completion
- 2021-05-01
- First posted
- 2020-08-19
- Last updated
- 2020-10-14
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04519424. Inclusion in this directory is not an endorsement.