CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,642 enrolled
Drug / intervention
CT-P59 +4 morebiological
Likely dose
CT-P59 40 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04602000
NCT04602000Phase 3Completed
CompareCT.gov

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

Celltrion·interventional·Posted Oct 26, 2020·Updated Jul 20, 2022

In Brief

A Phase 3 clinical trial evaluating CT-P59 and Placebo for SARS-CoV-2 Infection. Completed, enrolled 1,642 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2 Infection
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 26, 2020
Enrollment StartOct 5, 2020
Primary CompletionMay 21, 2021
Study CompletionOct 20, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.7 years ago

Interventions

CT-P59biological

CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

CT-P59biological

CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

Placebobiological

Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

CT-P59biological

CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

Placebobiological

Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)