SARS-CoV-2 InfectionPhase 1NCT04593641

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)

A Phase 1 study testing CT-P59 in people with SARS-CoV-2 Infection, run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: SARS-CoV-2 Infection
What is being tested?: CT-P59
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteSouth Korea
Study dates: 4 Sep 2020to 5 Apr 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Each patient must meet all of the following criteria to be randomized in this study:
Adult male or female patient, aged between 18 to 60 years (both inclusive).
Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
Patient has mild conditions meeting all of the following criteria:
Oxygen saturation ≥ 94% on room air.
Not requiring supplemental oxygen.
Onset of symptom is no more than 7 days prior to the study drug administration.

Who cannot join

1. Patient with severe condition meeting one of the following:
Respiratory distress with respiratory rate ≥ 30 breaths/min.
Requires supplemental oxygen.
Experience shock.
Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Incheon Medical Center
Incheon

Other trials in South Korea

About this study

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

Read the 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.

Conditions: SARS-CoV-2 Infection
Being tested: CT-P59
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P59Biological
administered

Study groups in NCT04593641
Study group	Role	What they receive
Cohort 1 will receive a dose of CT-P59 or matching placebo	Experimental	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59 Receives: Biological: CT-P59
Cohort 2 will receive a dose of CT-P59 or matching placebo	Experimental	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59 Receives: Biological: CT-P59
Cohort 3 will receive a dose of CT-P59 or matching placebo	Experimental	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59 Receives: Biological: CT-P59

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With TEAEs
Measured: Up to Day 14
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
Measured: Up to Day 14
Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)
Measured: Up to Day 14
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
Measured: Up to Day 14

Secondary outcomes (18)

The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
Measured: At Day 28
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Measured: Up to Day 28
Area Under the Concentration-time Curve of Viral Titers for qPCR
Measured: Up to Day 28
Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Measured: Up to Day 28
Number of Patients With Clinical Recovery
Measured: Up to Day 28
Number of Patients Requiring Supplemental Oxygen
Measured: Up to Day 28
Number of Patients With Intensive Care Unit Transfer
Measured: Up to Day 28
Number of Mechanical Ventilation
Measured: Up to Day 28
Number of Patients With All-cause Mortality
Measured: Up to Day 28
Number of Patients With Hospital Admission
Measured: Up to Day 28
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).
Measured: Up to Day 90
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).
Measured: Up to Day 90
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).
Measured: Up to Day 90
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).
Measured: Up to Day 90
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).
Measured: Up to Day 90
Terminal Elimination Rate Constant (λz) 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).
Measured: Up to Day 90
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).
Measured: Up to Day 90
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).
Measured: Up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 20205 Apr 2021

First posted20 Oct 2020
Study start4 Sep 2020
Primary completion26 Oct 2020
Study completion5 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04593641
Sponsor's protocol ID: CT-P59 1.2
Other IDs: 2020-003165-19
Status last verified: Apr 2022
First submitted: 5 Oct 2020
Last updated: 8 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PubMed 35713300
Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.
PubMed 34551869
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All SARS-CoV-2 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04593641
Acronym / sponsor ID: CT-P59 1.2
Conditions: SARS-CoV-2 Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 4 Sep 2020 (actual)
Primary completion: 26 Oct 2020 (actual)
Study completion: 5 Apr 2021 (actual)
First posted: 20 Oct 2020 (actual)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cohort 1 will receive a dose of CT-P59 or matching placebo	Experimental	Biological: CT-P59Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Cohort 2 will receive a dose of CT-P59 or matching placebo	Experimental	Biological: CT-P59Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Cohort 3 will receive a dose of CT-P59 or matching placebo	Experimental	Biological: CT-P59Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Adult male or female patient, aged between 18 to 60 years (both inclusive).
Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
Patient has mild conditions meeting all of the following criteria:
Onset of symptom is no more than 7 days prior to the study drug administration.

Key exclusion criteria (6 listed)

Respiratory distress with respiratory rate ≥ 30 breaths/min.
Requires supplemental oxygen.
Experience shock.
Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P59administered	Biological	Cohort 1 will receive a dose of CT-P59 or matching placebo, Cohort 2 will receive a dose of CT-P59 or matching placebo, Cohort 3 will receive a dose of CT-P59 or matching placebo

Primary outcome

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

18 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
Time frame: Up to Day 28
Number of Mechanical Ventilation
Time frame: Up to Day 28
Number of Patients With All-cause Mortality
Time frame: Up to Day 28
Number of Patients With Hospital Admission
Time frame: 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
Time to Cmax (Tmax) of CT-P59
Time frame: 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
Terminal Half-life (t1/2) of CT-P59
Time frame: Up to Day 90
Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59
Time frame: Up to Day 90
Terminal Elimination Rate Constant (λz) of CT-P59
Time frame: Up to Day 90
Total Body Clearance (CL) of CT-P59
Time frame: Up to Day 90
Volume of Distribution During the Elimination Phase (Vz) of CT-P59
Time frame: Up to Day 90

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P59 20 mg/kg	5	4
CT-P59 40 mg/kg	5	5
CT-P59 80 mg/kg	5	5
Placebo	3	3

Primary outcome: Number of Patients With TEAEs

Time frame: Up to Day 14. Count of participants. Unit: Participants

Measure	CT-P59 20 mg/kg n = 5	CT-P59 40 mg/kg n = 5	CT-P59 80 mg/kg n = 5	Placebo n = 3
Value	3	4	3	1

Population analysed: Safety set

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

Time frame: Up to Day 14. Count of participants. Unit: Participants

Measure	CT-P59 20 mg/kg n = 5	CT-P59 40 mg/kg n = 5	CT-P59 80 mg/kg n = 5	Placebo n = 3
Value	0	0	0	0

Population analysed: Safety set

Primary outcome: 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. Count of participants. Unit: Participants

Measure	CT-P59 20 mg/kg n = 5	CT-P59 40 mg/kg n = 5	CT-P59 80 mg/kg n = 5	Placebo n = 3
Value	0	0	0	0

Population analysed: Safety set.

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

Time frame: Up to Day 14. Count of participants. Unit: Participants

Measure	CT-P59 20 mg/kg n = 5	CT-P59 40 mg/kg n = 5	CT-P59 80 mg/kg n = 5	Placebo n = 3
Value	0	0	0	0

Population analysed: Safety set.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P59 20 mg/kg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
CT-P59 40 mg/kg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
CT-P59 80 mg/kg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35713300Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Derived from this study: PubMed 34551869Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.
Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-P59 in people with SARS-CoV-2 Infection, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With TEAEs (time frame: Up to Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593641, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.