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

June 27, 2022 updated by: Celltrion

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

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.

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 human monoclonal antibody targeted against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein as a treatment for SARS-CoV-2 infection, which is manufactured by recombinant deoxyribonucleic acid technology in a Chinese hamster ovary mammalian cell line. This Phase 2/3, randomized, parallel-group, placebo-controlled, double-blind study was designed to evaluate the safety, tolerability, and therapeutic potential of CT-P59 in outpatients with mild to moderate SARS-CoV-2 infection, not requiring supplemental oxygen therapy.

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.
1642

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 2
  • Phase 3

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

  • Korea, Republic of
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of, 35015
        • Chungnam national university hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient had to meet all of the following criteria to be randomized in this study.

  1. Patient was an adult male or female patient, aged 18 or above.
  2. Patient was diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR (reverse transcription-polymerase chain reaction).

  3. Patient with conditions meeting all of the following criteria:

    1. Oxygen saturation > 94% on room air.
    2. Not requiring supplemental oxygen.
  4. Patient who had an onset of symptom no more than 7 days prior to the study drug administration.
  5. 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.

Exclusion Criteria:

Patients meeting any of the following criteria were excluded from the study.

  1. Patient had current severe condition meeting one of the following:

    1. Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions.
    2. Respiratory distress with respiratory rate ≥30 breaths/min.
    3. Required supplemental oxygen
    4. Experienced shock
    5. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.

  2. Patient had received or had a plan to receive any of the following prohibited medications or treatments:

    1. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or 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
    2. Any SARS-CoV-2 human IV immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration
    3. 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
    4. Use of medications that are contraindicated with SoC
    5. SARS-CoV-2 vaccine prior to the study drug administration

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: Parallel 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: CT-P59 40 mg/kg group (Part 1)
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Names:
  • regdanvimab
Biological: CT-P59
CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Names:
  • regdanvimab
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Other Names:
  • regdanvimab
Experimental: CT-P59 80 mg/kg group (Part 1)
CT-P59 (regdanvimab), 80 mg/kg by IV infusion once
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Names:
  • regdanvimab
Biological: CT-P59
CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Names:
  • regdanvimab
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Other Names:
  • regdanvimab
Placebo Comparator: Placebo group (Part 1)
Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once
Biological: Placebo
Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Biological: Placebo
Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Experimental: CT-P59 40 mg/kg group (Part 2)
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Names:
  • regdanvimab
Biological: CT-P59
CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Names:
  • regdanvimab
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Other Names:
  • regdanvimab
Placebo Comparator: Placebo group (Part 2)
Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once
Biological: Placebo
Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Biological: Placebo
Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

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
Measure Description
Time Frame
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)
Time Frame: Up to Day 28
To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28
Up to Day 28
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Time Frame: Up to Day 14
To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14
Up to Day 14
Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)
Time Frame: Up to Day 14
To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14
Up to Day 14
Time to Clinical Recovery (Part 1)
Time Frame: Up to Day 14

To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14.

Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]).

To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Up to Day 14
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2)
Time Frame: Up to Day 28
To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in high-risk patients
Up to Day 28

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
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2)
Time Frame: Up to Day 28
To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in all randomized patients
Up to Day 28
Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)
Time Frame: Up to Day 14

To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in high-risk patients.

Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]).

To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Up to Day 14
Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)
Time Frame: Up to Day 14

To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in all randomized patients.

Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]).

To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Up to Day 14
Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)
Time Frame: Up to Day 28
To evaluate the additional efficacy of CT-P59
Up to Day 28
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Time Frame: Days 3, 7, 10, 14, 21, and 28
To evaluate the additional efficacy of CT-P59
Days 3, 7, 10, 14, 21, and 28
Time to Clinical Recovery (Part 1 and Part 2)
Time Frame: Up to Day 28

To evaluate the additional efficacy of CT-P59. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]).

To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.
Up to Day 28

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
[Virology] Viral Serology for SARS-CoV-2 Antibody
Time Frame: Days 1, 7, 14, 28, and 56
To assess the serology of SARS-CoV-2 antibody. The proportions of patients positive with IgG or IgM were summarized.
Days 1, 7, 14, 28, and 56
[PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1)
Time Frame: Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
To assess the PK of CT-P59
Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
[PK] Maximum Serum Concentration (Cmax) (Part 1)
Time Frame: Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
To assess the PK of CT-P59
Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
[PK] Terminal Half-life (t1/2) (Part 1)
Time Frame: Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
To assess the PK of CT-P59
Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion

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.
October 5, 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.
May 21, 2021

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.
October 20, 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 18, 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 23, 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 26, 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.
July 20, 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.
June 27, 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.
June 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 3.2
  • 2020-003369-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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