Back to resultsA Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
Primary Purpose
SARS-CoV-2 Infection
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT-P59
CT-P59
Placebo
CT-P59
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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
Sites / Locations
- Chungnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
CT-P59 40 mg/kg group (Part 1)
CT-P59 80 mg/kg group (Part 1)
Placebo group (Part 1)
CT-P59 40 mg/kg group (Part 2)
Placebo group (Part 2)
Arm Description
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
CT-P59 (regdanvimab), 80 mg/kg by IV infusion once
Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once
Outcomes
Primary Outcome Measures
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
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
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
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.
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
Secondary Outcome Measures
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
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.
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.
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
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
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
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
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
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04602000
Brief Title
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
October 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1642 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P59 40 mg/kg group (Part 1)
Arm Type
Experimental
Arm Description
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
Arm Title
CT-P59 80 mg/kg group (Part 1)
Arm Type
Experimental
Arm Description
CT-P59 (regdanvimab), 80 mg/kg by IV infusion once
Arm Title
Placebo group (Part 1)
Arm Type
Placebo Comparator
Arm Description
Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once
Arm Title
CT-P59 40 mg/kg group (Part 2)
Arm Type
Experimental
Arm Description
CT-P59 (regdanvimab), 40 mg/kg by IV infusion once
Arm Title
Placebo group (Part 2)
Arm Type
Placebo Comparator
Arm Description
Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once
Intervention Type
Biological
Intervention Name(s)
CT-P59
Other Intervention Name(s)
regdanvimab
Intervention Description
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Intervention Type
Biological
Intervention Name(s)
CT-P59
Other Intervention Name(s)
regdanvimab
Intervention Description
CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Intervention Type
Biological
Intervention Name(s)
CT-P59
Other Intervention Name(s)
regdanvimab
Intervention Description
CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Primary Outcome Measure Information:
Title
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)
Description
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
Time Frame
Up to Day 28
Title
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
Description
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 Frame
Up to Day 14
Title
Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)
Description
To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14
Time Frame
Up to Day 14
Title
Time to Clinical Recovery (Part 1)
Description
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.
Time Frame
Up to Day 14
Title
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)
Description
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
Time Frame
Up to Day 28
Secondary Outcome Measure Information:
Title
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)
Description
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
Time Frame
Up to Day 28
Title
Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)
Description
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.
Time Frame
Up to Day 14
Title
Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)
Description
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.
Time Frame
Up to Day 14
Title
Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Up to Day 28
Title
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
Description
To evaluate the additional efficacy of CT-P59
Time Frame
Days 3, 7, 10, 14, 21, and 28
Title
Time to Clinical Recovery (Part 1 and Part 2)
Description
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.
Time Frame
Up to Day 28
Other Pre-specified Outcome Measures:
Title
[Virology] Viral Serology for SARS-CoV-2 Antibody
Description
To assess the serology of SARS-CoV-2 antibody. The proportions of patients positive with IgG or IgM were summarized.
Time Frame
Days 1, 7, 14, 28, and 56
Title
[PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1)
Description
To assess the PK of CT-P59
Time Frame
Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
Title
[PK] Maximum Serum Concentration (Cmax) (Part 1)
Description
To assess the PK of CT-P59
Time Frame
Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
Title
[PK] Terminal Half-life (t1/2) (Part 1)
Description
To assess the PK of CT-P59
Time Frame
Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
35015
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36043180
Citation
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. Erratum In: Open Forum Infect Dis. 2023 Apr 19;10(4):ofad196.
Results Reference
derived
PubMed Identifier
35713300
Citation
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.
Results Reference
derived
PubMed Identifier
35295819
Citation
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.
Results Reference
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PubMed Identifier
34473343
Citation
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.
Results Reference
derived
Learn more about this trial
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
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