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)

April 6, 2022 updated by: Celltrion

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 will receive a dose of CT-P59 or matching placebo

Drug: CT-P59

CT-P59 will be administered

Drug: Placebo

Placebo-matching CT-P59
Biological: CT-P59
administered
Experimental: Cohort 2 will receive a dose of CT-P59 or matching placebo

Drug: CT-P59

CT-P59 will be administered

Drug: Placebo

Placebo-matching CT-P59
Biological: CT-P59
administered
Experimental: Cohort 3 will receive a dose of CT-P59 or matching placebo

Drug: CT-P59

CT-P59 will be administered

Drug: Placebo

Placebo-matching CT-P59
Biological: CT-P59
administered

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Patients With TEAEs
Time Frame: Up to Day 14
Up to Day 14
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Up to Day 14
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
Up to Day 14
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
Time Frame: Up to Day 14
Up to Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
Time Frame: At Day 28
At Day 28
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time Frame: Up to Day 28
Up to Day 28
Area Under the Concentration-time Curve of Viral Titers for qPCR
Time Frame: Up to Day 28
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
Up to Day 28
Number of Patients With Clinical Recovery
Time Frame: Up to Day 28
Up to Day 28
Number of Patients Requiring Supplemental Oxygen
Time Frame: Up to Day 28
Up to Day 28
Number of Patients With Intensive Care Unit Transfer
Time Frame: Up to Day 28
Up to Day 28
Number of Mechanical Ventilation
Time Frame: Up to Day 28
Up to Day 28
Number of Patients With All-cause Mortality
Time Frame: Up to Day 28
Up to Day 28
Number of Patients With Hospital Admission
Time Frame: Up to Day 28
Up to Day 28
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59
Time Frame: Up to Day 90
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
Time to Cmax (Tmax) of CT-P59
Time Frame: Up to Day 90
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
Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)
Time Frame: Up to Day 90
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
Terminal Half-life (t1/2) of CT-P59
Time Frame: Up to Day 90
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
Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59
Time Frame: Up to Day 90
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
Terminal Elimination Rate Constant (λz) of CT-P59
Time Frame: Up to Day 90
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
Total Body Clearance (CL) of CT-P59
Time Frame: Up to Day 90
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
Volume of Distribution During the Elimination Phase (Vz) of CT-P59
Time Frame: Up to Day 90
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celltrion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-P59 1.2
  • 2020-003165-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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