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

Sponsor
Celltrion (Industry)
Overall Status
Completed
CT.gov ID
NCT04602000
Collaborator
(none)
1,642
Enrollment
1
Location
5
Arms
12.5
Actual Duration (Months)
131.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CT-P59
  • Biological: CT-P59
  • Biological: Placebo
  • Biological: CT-P59
  • Biological: Placebo
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
1642 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 5, 2020
Actual Primary Completion Date :
May 21, 2021
Actual Study Completion Date :
Oct 20, 2021

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Experimental: CT-P59 80 mg/kg group (Part 1)

    CT-P59 (regdanvimab), 80 mg/kg by IV infusion once

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) [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

    2. Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) [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

    3. Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) [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

    4. Time to Clinical Recovery (Part 1) [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.

    5. 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) [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

    Secondary Outcome Measures

    1. 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) [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

    2. Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) [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.

    3. Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) [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.

    4. Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    5. Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    6. Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    7. Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    8. Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    9. Proportion of Patients With All-cause Mortality (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    10. Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) [Up to Day 28]

      To evaluate the additional efficacy of CT-P59

    11. Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) [Days 3, 7, 10, 14, 21, and 28]

      To evaluate the additional efficacy of CT-P59

    12. Time to Clinical Recovery (Part 1 and Part 2) [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.

    Other Outcome Measures

    1. [Virology] Viral Serology for SARS-CoV-2 Antibody [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.

    2. [PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1) [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

    3. [PK] Maximum Serum Concentration (Cmax) (Part 1) [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

    4. [PK] Terminal Half-life (t1/2) (Part 1) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    4. Oxygen saturation > 94% on room air.

    5. Not requiring supplemental oxygen.

    6. Patient who had an onset of symptom no more than 7 days prior to the study drug administration.

    7. 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:

    2. Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions.

    3. Respiratory distress with respiratory rate ≥30 breaths/min.

    4. Required supplemental oxygen

    5. Experienced shock

    6. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.

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

    8. 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

    9. Any SARS-CoV-2 human IV immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration

    10. 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

    11. Use of medications that are contraindicated with SoC

    12. SARS-CoV-2 vaccine prior to the study drug administration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chungnam National University Hospital Daejeon Jung-gu Korea, Republic of 35015

    Sponsors and Collaborators

    • Celltrion

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Celltrion
    ClinicalTrials.gov Identifier:
    NCT04602000
    Other Study ID Numbers:
    • CT-P59 3.2
    • 2020-003369-20
    First Posted:
    Oct 26, 2020
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    COVID-19

    Study Results

    Participant Flow

    Recruitment Details For Part 1, participants were screened from 23 study centers in 4 countries and were enrolled from 23 study centers in 4 countries. For Part 2, participants were screened from 60 study centers in 14 countries and were enrolled from 58 study centers in 13 countries.
    Pre-assignment Detail For Part 1, a total of 371 participants were screened and 327 participants were enrolled (44 screening failures) and randomized. For Part 2, a total of 1,467 participants were screened and 1,315 participants were enrolled (152 screening failures) and randomized.
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Period Title: Overall Study
    STARTED 105 111 111 656 659
    COMPLETED 97 103 105 618 608
    NOT COMPLETED 8 8 6 38 51

    Baseline Characteristics

    Arm/Group Title 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) Total
    Arm/Group Description CT-P59 (regdanvimab), 40 mg/kg by IV infusion once CT-P59: CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) CT-P59 (regdanvimab), 80 mg/kg by IV infusion once CT-P59: CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once Placebo: Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) CT-P59 (regdanvimab), 40 mg/kg by IV infusion once CT-P59: CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2) Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once Placebo: Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2) Total of all reporting groups
    Overall Participants 105 111 111 656 659 1642
    Age (Count of Participants)
    <=18 years
    1
    1%
    0
    0%
    0
    0%
    1
    0.2%
    5
    0.8%
    7
    0.4%
    Between 18 and 65 years
    89
    84.8%
    90
    81.1%
    93
    83.8%
    562
    85.7%
    576
    87.4%
    1410
    85.9%
    >=65 years
    15
    14.3%
    21
    18.9%
    18
    16.2%
    93
    14.2%
    78
    11.8%
    225
    13.7%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    51.0
    51.0
    52.0
    49.0
    47.0
    49.0
    Sex: Female, Male (Count of Participants)
    Female
    46
    43.8%
    52
    46.8%
    63
    56.8%
    309
    47.1%
    332
    50.4%
    802
    48.8%
    Male
    59
    56.2%
    59
    53.2%
    48
    43.2%
    347
    52.9%
    327
    49.6%
    840
    51.2%
    Race/Ethnicity, Customized (Count of Participants)
    White
    94
    89.5%
    96
    86.5%
    96
    86.5%
    563
    85.8%
    569
    86.3%
    1418
    86.4%
    African American/Black
    0
    0%
    0
    0%
    0
    0%
    6
    0.9%
    1
    0.2%
    7
    0.4%
    American Indian/Alaska native
    0
    0%
    0
    0%
    0
    0%
    5
    0.8%
    9
    1.4%
    14
    0.9%
    Asian
    11
    10.5%
    15
    13.5%
    15
    13.5%
    7
    1.1%
    7
    1.1%
    55
    3.3%
    Native Hawaiian/Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    0
    0%
    1
    0.1%
    Not allowed by investigator country regulations
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Other
    0
    0%
    0
    0%
    0
    0%
    74
    11.3%
    73
    11.1%
    147
    9%
    Region of Enrollment (participants) [Number]
    Hungary
    0
    0%
    0
    0%
    0
    0%
    25
    3.8%
    32
    4.9%
    57
    3.5%
    Italy
    0
    0%
    0
    0%
    0
    0%
    2
    0.3%
    2
    0.3%
    4
    0.2%
    South Korea
    11
    10.5%
    15
    13.5%
    14
    12.6%
    6
    0.9%
    6
    0.9%
    52
    3.2%
    North Macedonia
    0
    0%
    0
    0%
    0
    0%
    30
    4.6%
    26
    3.9%
    56
    3.4%
    Mexico
    0
    0%
    0
    0%
    0
    0%
    68
    10.4%
    70
    10.6%
    138
    8.4%
    Moldova
    0
    0%
    0
    0%
    0
    0%
    19
    2.9%
    18
    2.7%
    37
    2.3%
    Peru
    0
    0%
    0
    0%
    0
    0%
    11
    1.7%
    9
    1.4%
    20
    1.2%
    Poland
    0
    0%
    0
    0%
    0
    0%
    43
    6.6%
    47
    7.1%
    90
    5.5%
    Romania
    93
    88.6%
    90
    81.1%
    93
    83.8%
    315
    48%
    311
    47.2%
    902
    54.9%
    Serbia
    0
    0%
    0
    0%
    0
    0%
    23
    3.5%
    24
    3.6%
    47
    2.9%
    Spain
    0
    0%
    2
    1.8%
    1
    0.9%
    7
    1.1%
    14
    2.1%
    24
    1.5%
    Ukraine
    0
    0%
    0
    0%
    0
    0%
    58
    8.8%
    49
    7.4%
    107
    6.5%
    United States
    1
    1%
    4
    3.6%
    3
    2.7%
    49
    7.5%
    51
    7.7%
    108
    6.6%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    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)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1) Placebo Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103
    Count of Participants [Participants]
    4
    3.8%
    5
    4.5%
    9
    8.1%
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    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)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1) Placebo Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103
    Day 2
    0
    0%
    1
    0.9%
    0
    0%
    Day 3
    4
    3.8%
    4
    3.6%
    3
    2.7%
    Day 4
    2
    1.9%
    6
    5.4%
    4
    3.6%
    Day 5
    7
    6.7%
    3
    2.7%
    2
    1.8%
    Day 6
    5
    4.8%
    5
    4.5%
    4
    3.6%
    Day 7
    8
    7.6%
    12
    10.8%
    7
    6.3%
    Day 10
    19
    18.1%
    18
    16.2%
    19
    17.1%
    Day 14
    23
    21.9%
    19
    17.1%
    23
    20.7%
    3. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    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)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1) Placebo Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103
    Median (95% Confidence Interval) [days]
    12.75
    11.89
    12.94
    4. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    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; Patients who have absent for all symptoms or at least one missing at baseline are excluded.)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1) Placebo Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
    Measure Participants 95 92 98
    Median (95% Confidence Interval) [days]
    7.18
    7.30
    8.80
    5. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 2) Placebo Group (Part 2)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 446 434
    Count of Participants [Participants]
    14
    13.3%
    48
    43.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection CT-P59 40 mg/kg Group (Part 1), CT-P59 80 mg/kg Group (Part 1)
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value was calculated using CMH test stratified by age (≥60 vs. <60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other)
    Method of Estimation Estimation Parameter Difference estimated using CMH weights
    Estimated Value -8.0
    Confidence Interval (2-Sided) 95%
    -11.7 to -4.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments The 95% stratified Newcombe CI with CMH weights was presented.
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITT Set (defined as all randomly assigned patients to the study drug)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 2) Placebo Group (Part 2)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 656 659
    Count of Participants [Participants]
    16
    15.2%
    53
    47.7%
    7. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria; Patient who reported at least 1 symptom at baseline was included)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 2) Placebo Group (Part 2)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 429 406
    Median (95% Confidence Interval) [days]
    9.27
    NA
    8. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 2) Placebo Group (Part 2)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 629 618
    Median (95% Confidence Interval) [days]
    8.38
    13.25
    9. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 656 659
    Count of Participants [Participants]
    4
    3.8%
    5
    4.5%
    9
    8.1%
    16
    2.4%
    52
    7.9%
    10. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 656 659
    Count of Participants [Participants]
    4
    3.8%
    4
    3.6%
    9
    8.1%
    15
    2.3%
    49
    7.4%
    11. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 656 659
    Count of Participants [Participants]
    0
    0%
    1
    0.9%
    0
    0%
    0
    0%
    3
    0.5%
    12. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 656 659
    Count of Participants [Participants]
    7
    6.7%
    11
    9.9%
    15
    13.5%
    37
    5.6%
    85
    12.9%
    13. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 656 659
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5
    0.8%
    14. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 656 659
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    2
    0.3%
    15. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug; Patient who had positive result confirmed based on the negative threshold at baseline was included)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 612 618
    Median (95% Confidence Interval) [days]
    12.75
    11.89
    12.94
    11.90
    13.15
    16. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (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) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug; Patient who had positive result confirmed based on the negative threshold at baseline was included)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 612 618
    Day 3
    4
    3.8%
    4
    3.6%
    3
    2.7%
    34
    5.2%
    21
    3.2%
    Day 7
    8
    7.6%
    12
    10.8%
    7
    6.3%
    141
    21.5%
    94
    14.3%
    Day 10
    19
    18.1%
    18
    16.2%
    19
    17.1%
    137
    20.9%
    117
    17.8%
    Day 14
    23
    21.9%
    19
    17.1%
    23
    20.7%
    113
    17.2%
    149
    22.6%
    Day 21
    10
    9.5%
    8
    7.2%
    9
    8.1%
    99
    15.1%
    117
    17.8%
    Day 28
    6
    5.7%
    5
    4.5%
    5
    4.5%
    52
    7.9%
    61
    9.3%
    17. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set for Part 1 (all randomly assigned patients with confirmed SARS-CoV-2 infection by 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; Patients who had absent for all symptoms or at least one missing at baseline are excluded), and ITT Set for Part 2 (all randomly assigned patients to study drug; Patient who reported at least 1 symptom at baseline was included)
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 95 92 98 629 618
    Median (95% Confidence Interval) [days]
    7.18
    7.30
    8.80
    8.39
    13.29
    18. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result (Day 1) of RT-qPCR, who receive a complete or partial dose of study drug) for both Parts.
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Measure Participants 101 103 103 612 618
    IgG - Day 1
    0
    0%
    6
    5.4%
    3
    2.7%
    45
    6.9%
    35
    5.3%
    IgG - Day 7
    27
    25.7%
    32
    28.8%
    32
    28.8%
    354
    54%
    322
    48.9%
    IgG - Day 14
    77
    73.3%
    82
    73.9%
    86
    77.5%
    498
    75.9%
    509
    77.2%
    IgG - Day 28
    84
    80%
    94
    84.7%
    91
    82%
    535
    81.6%
    548
    83.2%
    IgG - Day 56
    78
    74.3%
    85
    76.6%
    86
    77.5%
    506
    77.1%
    532
    80.7%
    IgM - Day 1
    2
    1.9%
    6
    5.4%
    4
    3.6%
    53
    8.1%
    55
    8.3%
    IgM - Day 7
    38
    36.2%
    43
    38.7%
    49
    44.1%
    362
    55.2%
    332
    50.4%
    IgM - Day 14
    78
    74.3%
    82
    73.9%
    87
    78.4%
    467
    71.2%
    491
    74.5%
    IgM - Day 28
    59
    56.2%
    77
    69.4%
    65
    58.6%
    461
    70.3%
    493
    74.8%
    IgM - Day 56
    39
    37.1%
    54
    48.6%
    51
    45.9%
    407
    62%
    441
    66.9%
    19. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion [Day 1] result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result; If the pre-infusion result at Day 1 was confirmed negative or missing and the Day 2 result was confirmed positive, this patient was also included)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
    Measure Participants 29 32
    Mean (Standard Deviation) [h*μg/mL]
    212460.507
    (46724.5556)
    426694.643
    (121171.182)
    20. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
    Measure Participants 29 32
    Mean (Standard Deviation) [μg/mL]
    1016.6
    (268.97)
    2007.6
    (477.97)
    21. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result)
    Arm/Group Title CT-P59 40 mg/kg Group (Part 1) CT-P59 80 mg/kg Group (Part 1)
    Arm/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
    Measure Participants 29 32
    Mean (Standard Deviation) [h]
    403.916
    (147.8450)
    453.442
    (107.5620)

    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.
    Adverse Event Reporting Description The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance. Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE. The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug. All-cause
    Arm/Group Title 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/Group Description Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    All Cause Mortality
    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)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/105 (0%) 0/110 (0%) 0/110 (0%) 1/652 (0.2%) 2/650 (0.3%)
    Serious Adverse Events
    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)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/105 (0%) 0/110 (0%) 0/110 (0%) 6/652 (0.9%) 5/650 (0.8%)
    Cardiac disorders
    Acute myocardial infarction 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 1/652 (0.2%) 1 0/650 (0%) 0
    Angina unstable 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 1/652 (0.2%) 1 0/650 (0%) 0
    Gastrointestinal disorders
    Hiatus hernia 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 0/652 (0%) 0 1/650 (0.2%) 1
    Hepatobiliary disorders
    Cholelithiasis 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 0/652 (0%) 0 1/650 (0.2%) 1
    Infections and infestations
    Appendicitis 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 1/652 (0.2%) 1 0/650 (0%) 0
    Pneumonia 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 1/652 (0.2%) 1 0/650 (0%) 0
    Pneumonia bacterial 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 0/652 (0%) 0 1/650 (0.2%) 1
    Injury, poisoning and procedural complications
    Infusion related reaction 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 1/652 (0.2%) 1 0/650 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 0/652 (0%) 0 1/650 (0.2%) 1
    Intraocular melanoma 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 0/652 (0%) 0 1/650 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism 0/105 (0%) 0 0/110 (0%) 0 0/110 (0%) 0 1/652 (0.2%) 1 0/650 (0%) 0
    Other (Not Including Serious) Adverse Events
    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)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 19/105 (18.1%) 18/110 (16.4%) 17/110 (15.5%) 119/652 (18.3%) 128/650 (19.7%)
    Blood and lymphatic system disorders
    Leukopenia 3/105 (2.9%) 3 3/110 (2.7%) 3 0/110 (0%) 0 6/652 (0.9%) 6 12/650 (1.8%) 12
    Thrombocytosis 3/105 (2.9%) 3 1/110 (0.9%) 1 2/110 (1.8%) 2 11/652 (1.7%) 11 5/650 (0.8%) 5
    Infections and infestations
    Cystitis 3/105 (2.9%) 3 2/110 (1.8%) 2 0/110 (0%) 0 0/652 (0%) 0 1/650 (0.2%) 1
    Bacteriuria 2/105 (1.9%) 2 2/110 (1.8%) 2 2/110 (1.8%) 2 3/652 (0.5%) 3 3/650 (0.5%) 3
    Investigations
    Alanine aminotransferase increased 0/105 (0%) 0 1/110 (0.9%) 2 1/110 (0.9%) 1 19/652 (2.9%) 22 31/650 (4.8%) 34
    Blood creatine phosphokinase increased 5/105 (4.8%) 5 2/110 (1.8%) 2 1/110 (0.9%) 1 14/652 (2.1%) 14 10/650 (1.5%) 10
    C-reactive protein increased 1/105 (1%) 1 0/110 (0%) 0 0/110 (0%) 0 18/652 (2.8%) 18 10/650 (1.5%) 10
    Gamma-glutamyltransferase increased 0/105 (0%) 0 1/110 (0.9%) 1 1/110 (0.9%) 2 8/652 (1.2%) 8 20/650 (3.1%) 20
    Hepatic enzyme increased 0/105 (0%) 0 2/110 (1.8%) 2 0/110 (0%) 0 21/652 (3.2%) 21 15/650 (2.3%) 16
    Inflammatory marker increased 0/105 (0%) 0 3/110 (2.7%) 3 2/110 (1.8%) 2 14/652 (2.1%) 14 17/650 (2.6%) 18
    Metabolism and nutrition disorders
    Dyslipidaemia 4/105 (3.8%) 4 3/110 (2.7%) 3 2/110 (1.8%) 2 7/652 (1.1%) 7 9/650 (1.4%) 9
    Hyperglycaemia 2/105 (1.9%) 2 2/110 (1.8%) 2 3/110 (2.7%) 4 12/652 (1.8%) 12 9/650 (1.4%) 9
    Hyperkalaemia 1/105 (1%) 1 3/110 (2.7%) 5 2/110 (1.8%) 2 9/652 (1.4%) 10 6/650 (0.9%) 7
    Hypertriglyceridaemia 6/105 (5.7%) 7 0/110 (0%) 0 3/110 (2.7%) 5 29/652 (4.4%) 35 33/650 (5.1%) 40
    Nervous system disorders
    Dizziness 0/105 (0%) 0 0/110 (0%) 0 3/110 (2.7%) 4 0/652 (0%) 0 2/650 (0.3%) 2
    Psychiatric disorders
    Insomnia 0/105 (0%) 0 3/110 (2.7%) 3 1/110 (0.9%) 1 0/652 (0%) 0 5/650 (0.8%) 5
    Vascular disorders
    Hypertension 1/105 (1%) 1 1/110 (0.9%) 1 0/110 (0%) 0 17/652 (2.6%) 22 14/650 (2.2%) 15

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Yun Ju Bae / Head of Clinical Planning 1 Department
    Organization Celltrion, Inc
    Phone +82 32 850 4160
    Email YunJu.Bae@celltrion.com
    Responsible Party:
    Celltrion
    ClinicalTrials.gov Identifier:
    NCT04602000
    Other Study ID Numbers:
    • CT-P59 3.2
    • 2020-003369-20
    First Posted:
    Oct 26, 2020
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jun 1, 2022