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)

SARS-CoV-2 Infection Clinical Trial

Official title:

A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593641
• Other study ID #: CT-P59 1.2
• Secondary ID: 2020-003165-19
• Status: Completed
• Phase: Phase 1
• Start date: September 4, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2022
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

'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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 5, 2021
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Biological:
• CT-P59
administered

Locations

Country	Name	City	State
Korea, Republic of	Incheon Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With TEAEs		Up to Day 14
Primary	Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)		Up to Day 14
Primary	Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)		Up to Day 14
Primary	Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)		Up to Day 14
Secondary	The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)		At Day 28
Secondary	Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR		Up to Day 28
Secondary	Area Under the Concentration-time Curve of Viral Titers for qPCR		Up to Day 28
Secondary	Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR		Up to Day 28
Secondary	Number of Patients With Clinical Recovery		Up to Day 28
Secondary	Number of Patients Requiring Supplemental Oxygen		Up to Day 28
Secondary	Number of Patients With Intensive Care Unit Transfer		Up to Day 28
Secondary	Number of Mechanical Ventilation		Up to Day 28
Secondary	Number of Patients With All-cause Mortality		Up to Day 28
Secondary	Number of Patients With Hospital Admission		Up to Day 28
Secondary	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Time to Cmax (Tmax) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Terminal Half-life (t1/2) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Terminal Elimination Rate Constant (?z) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Total Body Clearance (CL) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90
Secondary	Volume of Distribution During the Elimination Phase (Vz) of CT-P59	The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).	Up to Day 90