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 : Approved
First Submitted Date : 2020/11/20     Registered Date : 2020/11/27     Last Updated Date : 2022/06/23    

This was a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate severe acute respiratory syndrome coronavirus (SARS-CoV-2)  infected patients and the safety during the study.

Test Investigational Product:
Part 1
• CT-P59 80 mg/kg by single intravenous (IV) infusion over 90 minutes (±15 minutes) with Standard of Care (SoC)
• CT-P59 40 mg/kg by single IV infusion over 90 minutes (±15 minutes) with SoC
Part 2
• CT-P59 40 mg/kg by single IV infusion over 60 minutes (±15 minutes) with SoC

Reference Investigational Product:
Part 1
• Placebo matching in volume of CT-P59 80 mg/kg by single IV infusion over 90 minutes (±15 minutes) with SoC
Part 2
• Placebo matching in volume of CT-P59 40 mg/kg by single IV infusion over 60 minutes (±15 minutes) with SoC

CT-P59 40 mg/kg (Part 1)

CT-P59 40 mg/kg is administered as an intravenous (IV) infusion over 90 minutes (± 15 minutes).
In Part 1, subjects are randomly assigned into CT-P59 40 mg/kg, CT-P59 80 mg/kg or placebo groups as 1:1:1 ratio.

CT-P59 80 mg/kg (Part 1)

CT-P59 80 mg/kg is administered as an IV infusion over 90 minutes (± 15 minutes).
In Part 1, subjects are randomly assigned into CT-P59 40 mg/kg, CT-P59 80 mg/kg or placebo groups as 1:1:1 ratio.

Placebo (Part 1)

Placebo matching in volume of CT-P59 80 mg/kg is administered as an IV infusion over 90 minutes (± 15 minutes).
In Part 1, subjects are randomly assigned into CT-P59 40 mg/kg, CT-P59 80 mg/kg or placebo groups as 1:1:1 ratio.

CT-P59 40 mg/kg (Part 2)

CT-P59 40 mg/kg is administered as an IV infusion over 60 minutes (± 15 minutes).
In Part 2, patients are randomly assigned into CT-P59 40 mg/kg or placebo groups as 1:1 ratio.

Placebo (Part 2)

Placebo matching in volume of CT-P59 40 mg/kg is administered as an IV infusion over 60 minutes (± 15 minutes).
In Part 2, patients are randomly assigned into CT-P59 40 mg/kg or placebo groups as 1:1 ratio.

• Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR. 
• Oxygen saturation >94% on room air, and not requiring supplemental oxygen.
• Patient whose onset of symptom is no more than 7 days prior to the study drug administration.
• Patient had 1 or more of the SARS-CoV-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration.

• Patient had current severe condition meeting one of the following:
a. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions (severe disease as defined in the World Health Organization Guidance, 2020).
b. Respiratory distress with respiratory rate ≥30 breaths/min.
c. Required supplemental oxygen.
d. Experienced shock.
e. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion.
• Patient had received or had a plan to receive any of following prohibited medications or treatments:
a. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration.
b. Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration.
c. Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration.
d. Use of medications that are contraindicated with SoC.
e. SARS-CoV-2 vaccine prior to the study drug administration

Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection (Part 1)

Up to Day 28

Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR at each visit (Part 1)

Up to Day 14

Time to negative conversion in nasopharyngeal swab specimen (Part 1)

Up to Day 14

Time to clinical recovery (Part 1)

Up to Day 14

Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection in high-risk patients (Part 2)

Up to Day 28

Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection in all randomized patients (Part 2)

Up to Day 28

Time to clinical recovery in high-risk patients (Part 2)

Up to Day 14

Time to clinical recovery in all randomized patients (Part 2)

Up to Day 14

Proportion of patients with hospital admission due to SARS-CoV-2 Infection (Part 1 and Part 2)

Up to Day 28

Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 Infection (Part 1 and Part 2)

Up to Day 28

Proportion of Patients with Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)

Up to Day 28

Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)

Up to Day 28

Proportion of Patients with Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)

Up to Day 28

Proportion of Patients with All-cause mortality Due to SARS-CoV-2 Infection (Part 1 and Part 2)

Up to Day 28

Adverse events (AEs; including serious adverse events [SAEs])

Throughout the study