SARS-CoV-2 InfectionPhase 2/3NCT04602000

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

A Phase 2/3 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 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: SARS-CoV-2 Infection
What is being tested?: CT-P59
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,642 participants
Where: 1 siteSouth Korea
Study dates: 5 Oct 2020to 20 Oct 2021
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient had to meet all of the following criteria to be randomized in this study.
Patient was an adult male or female patient, aged 18 or above.
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).
Patient with conditions meeting all of the following criteria:
Oxygen saturation > 94% on room air.
Not requiring supplemental oxygen.
Patient who had an onset of symptom no more than 7 days prior to the study drug administration.
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.

Who cannot join

Patients meeting any of the following criteria were excluded from the study.
Patient had current severe condition meeting one of the following:
Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions.
Respiratory distress with respiratory rate ≥30 breaths/min.
Required supplemental oxygen
Experienced shock

Show all 13Show fewer

Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
Patient had received or had a plan to receive any of the following prohibited medications or treatments:
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
Any SARS-CoV-2 human IV immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration
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
Use of medications that are contraindicated with SoC
SARS-CoV-2 vaccine prior to the study drug administration

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chungnam National University Hospital
Daejeon, Jung-gu, 35015

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions: SARS-CoV-2 Infection
Being tested: CT-P59, Placebo
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
Also called regdanvimab
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
CT-P59Biological
Also called regdanvimab
CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
PlaceboBiological
Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
CT-P59Biological
Also called regdanvimab
CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
PlaceboBiological
Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

Study groups in NCT04602000
Study group	Role	What they receive
CT-P59 40 mg/kg group (Part 1)	Experimental	CT-P59 (regdanvimab), 40 mg/kg by IV infusion once Receives: Biological: CT-P59
CT-P59 80 mg/kg group (Part 1)	Experimental	CT-P59 (regdanvimab), 80 mg/kg by IV infusion once Receives: Biological: CT-P59
Placebo group (Part 1)	Placebo comparator	Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once Receives: Biological: Placebo
CT-P59 40 mg/kg group (Part 2)	Experimental	CT-P59 (regdanvimab), 40 mg/kg by IV infusion once Receives: Biological: CT-P59
Placebo group (Part 2)	Placebo comparator	Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once Receives: Biological: Placebo

What is being measured

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

Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)
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
Measured: Up to Day 28
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
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
Measured: Up to Day 14
Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)
To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14
Measured: Up to Day 14
Time to Clinical Recovery (Part 1)
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.
Measured: 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)
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
Measured: Up to Day 28

Secondary outcomes (12)

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)
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
Measured: Up to Day 28
Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)
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.
Measured: Up to Day 14
Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)
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.
Measured: Up to Day 14
Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: Up to Day 28
Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: Up to Day 28
Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: Up to Day 28
Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: Up to Day 28
Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: Up to Day 28
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: Up to Day 28
Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Measured: 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)
To evaluate the additional efficacy of CT-P59
Measured: Days 3, 7, 10, 14, 21, and 28
Time to Clinical Recovery (Part 1 and Part 2)
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.
Measured: Up to Day 28

Timeline

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

5 Oct 202020 Oct 2021

First posted26 Oct 2020
Study start5 Oct 2020
Primary completion21 May 2021
Study completion20 Oct 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 (4)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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,642 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04602000
Sponsor's protocol ID: CT-P59 3.2
Other IDs: 2020-003369-20
Status last verified: Jun 2022
First submitted: 18 Oct 2020
Last updated: 20 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kim JY, Sandulescu O, Preotescu LL, Rivera-Martinez NE, Dobryanska M, Birlutiu V, Miftode EG, Gaibu N, Caliman-Sturdza O, Florescu SA, Shi HJ, Streinu-Cercel A, Streinu-Cercel A, Lee SJ, Kim SH, Chang I, Bae YJ, Suh JH, Chung DR, Kim SJ, Kim MR, Lee SG, Park G, Eom JS. A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Aug 8;9(8):ofac406. doi: 10.1093/ofid/ofac406. eCollection 2022 Aug.
PubMed 36043180
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
Streinu-Cercel A, Sandulescu O, Preotescu LL, Kim JY, Kim YS, Cheon S, Jang YR, Lee SJ, Kim SH, Chang I, Suh JH, Lee SG, Kim MR, Chung DR, Kim HN, Streinu-Cercel A, Eom JS. Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Feb 2;9(4):ofac053. doi: 10.1093/ofid/ofac053. eCollection 2022 Apr.
PubMed 35295819
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

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

All SARS-CoV-2 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04602000
Acronym / sponsor ID: CT-P59 3.2
Conditions: SARS-CoV-2 Infection
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,642 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 5 Oct 2020 (actual)
Primary completion: 21 May 2021 (actual)
Study completion: 20 Oct 2021 (actual)
First posted: 26 Oct 2020 (actual)
Results: Posted 20 Jul 2022

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
CT-P59 40 mg/kg group (Part 1)	Experimental	Biological: CT-P59CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
CT-P59 80 mg/kg group (Part 1)	Experimental	Biological: CT-P59CT-P59 (regdanvimab), 80 mg/kg by IV infusion once
Placebo group (Part 1)	Placebo comparator	Biological: PlaceboPlacebo, matching in volume of CT-P59 80 mg/kg by IV infusion once
CT-P59 40 mg/kg group (Part 2)	Experimental	Biological: CT-P59CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
Placebo group (Part 2)	Placebo comparator	Biological: PlaceboPlacebo, matching in volume of CT-P59 40 mg/kg by IV infusion once

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient had to meet all of the following criteria to be randomized in this study.
Patient was an adult male or female patient, aged 18 or above.
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).
Patient with conditions meeting all of the following criteria:
Patient who had an onset of symptom no more than 7 days prior to the study drug administration.

Key exclusion criteria (13 listed)

Patients meeting any of the following criteria were excluded from the study.
Patient had current severe condition meeting one of the following:
Patient had received or had a plan to receive any of the following prohibited medications or treatments:

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-P59Also: regdanvimabCT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)	Biological	CT-P59 40 mg/kg group (Part 1)
CT-P59Also: regdanvimabCT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)	Biological	CT-P59 80 mg/kg group (Part 1)
PlaceboPlacebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)	Biological	Placebo group (Part 1)
CT-P59Also: regdanvimabCT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)	Biological	CT-P59 40 mg/kg group (Part 2)
PlaceboPlacebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)	Biological	Placebo group (Part 2)

Primary outcome

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
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
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
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.
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

12 secondary outcomes

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
Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)
Time frame: Up to Day 14
Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)
Time frame: 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
Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time frame: 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
Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Time frame: 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
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
Time frame: 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
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
Time to Clinical Recovery (Part 1 and Part 2)
Time frame: Up to Day 28

Results and safety

Results posted to the registry on 20 Jul 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 40 mg/kg Group (Part 1)	105	97
CT-P59 80 mg/kg Group (Part 1)	111	103
Placebo Group (Part 1)	111	105
CT-P59 40 mg/kg Group (Part 2)	656	618
Placebo Group (Part 2)	659	608

Primary outcome: 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. Count of participants. Unit: Participants

Measure	CT-P59 40 mg/kg Group (Part 1) n = 101	CT-P59 80 mg/kg Group (Part 1) n = 103	Placebo Group (Part 1) n = 103
Value	4	5	9

Population analysed: ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included)

Primary outcome: 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. Count of participants. Unit: Participants

Measure	CT-P59 40 mg/kg Group (Part 1) n = 101	CT-P59 80 mg/kg Group (Part 1) n = 103	Placebo Group (Part 1) n = 103
Day 2	0	1	0
Day 3	4	4	3
Day 4	2	6	4
Day 5	7	3	2
Day 6	5	5	4
Day 7	8	12	7
Day 10	19	18	19
Day 14	23	19	23

Primary outcome: Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)

Time frame: Up to Day 14. Median (95% Confidence Interval). Unit: days

Measure	CT-P59 40 mg/kg Group (Part 1) n = 101	CT-P59 80 mg/kg Group (Part 1) n = 103	Placebo Group (Part 1) n = 103
Value	12.75 (9.00 to 12.84)	11.89 (8.94 to 12.91)	12.94 (12.75 to 13.99)

Primary outcome: Time to Clinical Recovery (Part 1)

Time frame: Up to Day 14. Median (95% Confidence Interval). Unit: days

Measure	CT-P59 40 mg/kg Group (Part 1) n = 95	CT-P59 80 mg/kg Group (Part 1) n = 92	Placebo Group (Part 1) n = 98
Value	7.18 (5.50 to 9.37)	7.30 (5.72 to 9.33)	8.80 (6.88 to 13.09)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P59 40 mg/kg Group (Part 1)	0 of 105 (0%)	19 of 105 (18.1%)	0 of 105
CT-P59 80 mg/kg Group (Part 1)	0 of 110 (0%)	18 of 110 (16.4%)	0 of 110
Placebo Group (Part 1)	0 of 110 (0%)	17 of 110 (15.5%)	0 of 110
CT-P59 40 mg/kg Group (Part 2)	6 of 652 (0.9%)	119 of 652 (18.3%)	1 of 652
Placebo Group (Part 2)	5 of 650 (0.8%)	128 of 650 (19.7%)	2 of 650

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36043180Kim JY, Sandulescu O, Preotescu LL, Rivera-Martinez NE, Dobryanska M, Birlutiu V, Miftode EG, Gaibu N, Caliman-Sturdza O, Florescu SA, Shi HJ, Streinu-Cercel A, Streinu-Cercel A, Lee SJ, Kim SH, Chang I, Bae YJ, Suh JH, Chung DR, Kim SJ, Kim MR, Lee SG, Park G, Eom JS. A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Aug 8;9(8):ofac406. doi: 10.1093/ofid/ofac406. eCollection 2022 Aug.
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 35295819Streinu-Cercel A, Sandulescu O, Preotescu LL, Kim JY, Kim YS, Cheon S, Jang YR, Lee SJ, Kim SH, Chang I, Suh JH, Lee SG, Kim MR, Chung DR, Kim HN, Streinu-Cercel A, Eom JS. Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Feb 2;9(4):ofac053. doi: 10.1093/ofid/ofac053. eCollection 2022 Apr.
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.
Individual participant dataSharing planned: No

Related trials for SARS-CoV-2 Infection

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

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 2/3 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 8 inclusion and 13 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 20 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Jul 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?

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). The study lists 5 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 NCT04602000, which also lists 4 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 20 Jul 2022.