Trials / Completed
CompletedNCT04602000
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With SARS-CoV-2 Infection
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,642 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This was a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate SARS-CoV-2 infected patients and the safety during after study drug injection.
Detailed description
CT-P59 is a human monoclonal antibody targeted against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein as a treatment for SARS-CoV-2 infection, which is manufactured by recombinant deoxyribonucleic acid technology in a Chinese hamster ovary mammalian cell line. This Phase 2/3, randomized, parallel-group, placebo-controlled, double-blind study was designed to evaluate the safety, tolerability, and therapeutic potential of CT-P59 in outpatients with mild to moderate SARS-CoV-2 infection, not requiring supplemental oxygen therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P59 | CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) |
| BIOLOGICAL | CT-P59 | CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) |
| BIOLOGICAL | Placebo | Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) |
| BIOLOGICAL | CT-P59 | CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2) |
| BIOLOGICAL | Placebo | Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2) |
Timeline
- Start date
- 2020-10-05
- Primary completion
- 2021-05-21
- Completion
- 2021-10-20
- First posted
- 2020-10-26
- Last updated
- 2022-07-20
- Results posted
- 2022-07-20
Locations
1 site across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04602000. Inclusion in this directory is not an endorsement.