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A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection

NCT04602000 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1642

Last updated 2022-07-20

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2021-05-21
Completion
2021-10-20
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04602000 on ClinicalTrials.gov