This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)

Celltrion18 enrolled

Overview

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.

'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

SARS-CoV-2 Infection

Interventions

CT-P59BIOLOGICAL

administered

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: Each patient must meet all of the following criteria to be randomized in this study: 1. Adult male or female patient, aged between 18 to 60 years (both inclusive). 2. Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening. 3. Patient has mild conditions meeting all of the following criteria: 1. Oxygen saturation ≥ 94% on room air. 2. Not requiring supplemental oxygen. 4. Onset of symptom is no more than 7 days prior to the study drug administration. Exclusion Criteria: 1\. Patient with severe condition meeting one of the following: 1. Respiratory distress with respiratory rate ≥ 30 breaths/min. 2. Requires supplemental oxygen. 3. Experience shock. 4. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion. 5. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.

Locations (1)

Incheon Medical Center

Incheon, South Korea

Outcomes

Primary Outcomes

Number of Patients With TEAEs

Time frame: Up to Day 14

Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)

Time frame: Up to Day 14

Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)

Time frame: Up to Day 14

Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)

Time frame: Up to Day 14

Secondary Outcomes

The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)

Time frame: At Day 28

Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

Time frame: Up to Day 28

Area Under the Concentration-time Curve of Viral Titers for qPCR

Time frame: Up to Day 28

Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

Time frame: Up to Day 28

Number of Patients With Clinical Recovery

Time frame: Up to Day 28

Number of Patients Requiring Supplemental Oxygen

Time frame: Up to Day 28

Number of Patients With Intensive Care Unit Transfer

Data from ClinicalTrials.gov

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