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    Clinical Trial Results:
    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 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection

    Summary
    EudraCT number
    		 2020-003369-20
    Trial protocol
    		 IE   RO   HU   IT  
    Global end of trial date
    20 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2022
    First version publication date
    03 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-P59_3.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04602000
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CELLTRION Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014
    Public contact
    Sung Hyun Kim, CELLTRION, Inc., +82 32850 5000, SungHyun.Kim@celltrion.com
    Scientific contact
    Sung Hyun Kim, CELLTRION, Inc., +82 32850 5000, SungHyun.Kim@celltrion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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 -To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR at each visit up to Day 14 -To assess the potential therapeutic efficacy of CT-P59 as determined by time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14 -To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 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
    Protection of trial subjects
    CT-P59 was diluted and administered intravenously over 90 minutes in Part 1 (60 minutes in Part 2) by a nurse or doctor. The rate of infusion would be slowed or interrupted if the patient developed any signs of infusion related reactions or other adverse reactions and appropriate treatment were initiated as necessary. Hypersensitivity was assessed by vital sign monitoring on the day of study drug administration at the time points: Prior to the beginning of study drug administration (within 30 minutes), 30 minutes (±15 minutes) and 60 minutes (±15 minutes) after the start of study drug administration, 15 minutes after the end of study drug administration (+15 minutes), 2 hours (±15 minutes) and 4 hours (±15 minutes) after the start of study drug administration. In addition, hypersensitivity was monitored by routine continuous clinical monitoring. In case of hypersensitivity, emergency medication and equipment (such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilation) were made available, and any types of ECG could be performed if a patient experienced cardiac symptoms. For patients who experienced or developed life-threatening treatment-related hypersensitivity reactions, study drug was stopped immediately.
    Background therapy
    		 All enrolled patients were given optimal standard of care, which included rehydration therapy, antipyretics, or antitussives prescribed at the investigator's discretion. The routine use of antibiotics was not recommended, but antibiotics could be used if bacterial infections were present or suspected. The type of antibiotic would be selected based on the patient's clinical disease status and symptoms at the investigator's discretion.
    Evidence for comparator
    		 Placebo contained the same ingredient as the CT-P59 formulation listed above, excluding SARS-CoV-2 receptor binding domain binding monoclonal antibody, in 16 mL water for injection. The pH of the placebo solution was 6.0.
    Actual start date of recruitment
    05 Oct 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 57
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 52
    Country: Number of subjects enrolled
    North Macedonia: 56
    Country: Number of subjects enrolled
    Mexico: 138
    Country: Number of subjects enrolled
    Moldova, Republic of: 37
    Country: Number of subjects enrolled
    Peru: 20
    Country: Number of subjects enrolled
    Poland: 90
    Country: Number of subjects enrolled
    Romania: 902
    Country: Number of subjects enrolled
    Serbia: 47
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Ukraine: 107
    Country: Number of subjects enrolled
    United States: 108
    Worldwide total number of subjects
    1642
    EEA total number of subjects
    1077
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1417
    From 65 to 84 years
    220
    85 years and over
    5

    Subject disposition

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    Recruitment
    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
    Screening details
    		 Main Selection Criteria: - Adult male or female, aged 18 years or older - Patients diagnosed with SARS-CoV-2 infection at Screening - Patient with oxygen saturation >94% on room air and not requiring supplemental oxygen - Patient whose onset of symptom is no more than 7 days

    Period 1
    Period 1 title
    Part 1 + Part 2 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This study was double-blinded and the investigators, all designated study staff (with the exception of the unblinded study pharmacists or unblinded staff designated to prepare the study drug for infusion and predefined unblinded teams in the sponsor and CRO), and patients remained blinded until the generation of this final clinical study report.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CT-P59 40 mg/kg group (Part 1)
    Arm description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P59
    Investigational medicinal product code
    Other name
    regdanvimab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - CT-P59 was supplied as a sterile, preservative-free solution of SARS-CoV-2 RBD binding monoclonal antibody in a 20 mL single-use vial for IV infusion. CT-P59 is a clear to opalescent, colorless to pale yellow solution for injection, with a pH of 6.0 and 960 mg of SARS-CoV-2 RBD binding monoclonal antibody in 16 mL for IV infusion. - CT-P59 40 mg/kg was administered by single intravenous infusion over 90 minutes (±15 minutes) on Day 1. - A 250 mL infusion solution of 0.9% weight/volume sodium chloride was used for the patient infusions. The bag was gently inverted to mix the solution in order to avoid foaming. Parenteral solutions were inspected visually for particulates and discoloration prior to administration, and administration was not performed if any particulates or discoloration were found. The detailed method for mixing the solution was described in the pharmacy manual.

    Arm title
    		 CT-P59 80 mg/kg group (Part 1)
    Arm description
    		 Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P59
    Investigational medicinal product code
    Other name
    regdanvimab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - CT-P59 was supplied as a sterile, preservative-free solution of SARS-CoV-2 RBD binding monoclonal antibody in a 20 mL single-use vial for IV infusion. CT-P59 is a clear to opalescent, colorless to pale yellow solution for injection, with a pH of 6.0 and 960 mg of SARS-CoV-2 RBD binding monoclonal antibody in 16 mL for IV infusion. - CT-P59 80 mg/kg was administered by single intravenous infusion over 90 minutes (±15 minutes) on Day 1. - A 250 mL infusion solution of 0.9% weight/volume sodium chloride was used for the patient infusions. The bag was gently inverted to mix the solution in order to avoid foaming. Parenteral solutions were inspected visually for particulates and discoloration prior to administration, and administration was not performed if any particulates or discoloration were found. The detailed method for mixing the solution was described in the pharmacy manual.

    Arm title
    		 Placebo group (Part 1)
    Arm description
    		 Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Placebo contained the same ingredient as the CT-P59 formulation listed above, excluding SARS-CoV-2 RBD binding monoclonal antibody, in 16 mL water for injection. The pH of the placebo solution was 6.0. - Placebo matching in volume of CT-P59 80 mg/kg was administered by single intravenous infusion over 90 minutes (±15 minutes) on Day 1. - A 250 mL infusion solution of 0.9% weight/volume sodium chloride was used for the patient infusions. The bag was gently inverted to mix the solution in order to avoid foaming. Parenteral solutions were inspected visually for particulates and discoloration prior to administration, and administration was not performed if any particulates or discoloration were found. The detailed method for mixing the solution was described in the pharmacy manual.

    Arm title
    		 CT-P59 40 mg/kg group (Part 2)
    Arm description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P59
    Investigational medicinal product code
    Other name
    regdanvimab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - CT-P59 was supplied as a sterile, preservative-free solution of SARS-CoV-2 RBD binding monoclonal antibody in a 20 mL single-use vial for IV infusion. CT-P59 is a clear to opalescent, colorless to pale yellow solution for injection, with a pH of 6.0 and 960 mg of SARS-CoV-2 RBD binding monoclonal antibody in 16 mL for IV infusion. - CT-P59 40 mg/kg was administered by single intravenous infusion over 60 minutes (±15 minutes) on Day 1. - A 250 mL infusion solution of 0.9% weight/volume sodium chloride was used for the patient infusions. The bag was gently inverted to mix the solution in order to avoid foaming. Parenteral solutions were inspected visually for particulates and discoloration prior to administration, and administration was not performed if any particulates or discoloration were found. The detailed method for mixing the solution was described in the pharmacy manual.

    Arm title
    		 Placebo group (Part 2)
    Arm description
    		 Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Placebo contained the same ingredient as the CT-P59 formulation listed above, excluding SARS-CoV-2 RBD binding monoclonal antibody, in 16 mL water for injection. The pH of the placebo solution was 6.0. - Placebo matching in volume of CT-P59 40 mg/kg was administered by single intravenous infusion over 60 minutes (±15 minutes) on Day 1. - A 250 mL infusion solution of 0.9% weight/volume sodium chloride was used for the patient infusions. The bag was gently inverted to mix the solution in order to avoid foaming. Parenteral solutions were inspected visually for particulates and discoloration prior to administration, and administration was not performed if any particulates or discoloration were found. The detailed method for mixing the solution was described in the pharmacy manual.

    Number of subjects in period 1
    		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)
    Started
    105
    111
    111
    656
    659
    Completed
    97
    103
    105
    618
    608
    Not completed
    8
    8
    6
    38
    51
         Consent withdrawn by subject
    3
    6
    3
    27
    39
         Physician decision
    1
    -
    -
    2
    2
         Not entered into Follow-up period
    -
    -
    1
    -
    -
         other
    4
    2
    2
    6
    6
         Lost to follow-up
    -
    -
    -
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P59 40 mg/kg group (Part 1)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.

    Reporting group title
    CT-P59 80 mg/kg group (Part 1)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.

    Reporting group title
    Placebo group (Part 1)
    Reporting group description
    		 Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.

    Reporting group title
    CT-P59 40 mg/kg group (Part 2)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.

    Reporting group title
    Placebo group (Part 2)
    Reporting group description
    		 Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.

    Reporting group values
    		 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
    Number of subjects
    		 105 111 111 656 659 1642
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 90 90 93 563 581 1417
        Elderly (≥65 year)
    		 15 21 18 93 78 225
    Gender categorical
    Units: Subjects
        Female
    		 46 52 63 309 332 802
        Male
    		 59 59 48 347 327 840

    End points

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    End points reporting groups
    Reporting group title
    CT-P59 40 mg/kg group (Part 1)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.

    Reporting group title
    CT-P59 80 mg/kg group (Part 1)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.

    Reporting group title
    Placebo group (Part 1)
    Reporting group description
    		 Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.

    Reporting group title
    CT-P59 40 mg/kg group (Part 2)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.

    Reporting group title
    Placebo group (Part 2)
    Reporting group description
    		 Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.

    Subject analysis set title
    ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Set was defined as all patients randomly assigned to study drug. It is applied for both Part 1 and Part 2.

    Subject analysis set title
    ITTI Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The ITTI (Intent-to-treat Infected) Set was defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR and who received a complete or partial dose of the study drug. If the pre-infusion result at Day 1 was confirmed negative or missing and the Day 2 (or Day 3 for Part 2) result was confirmed positive, this patient was also considered as confirmed SARS-CoV-2 infection. It is applied for both Part 1 and Part 2.

    Subject analysis set title
    ITT Set - High Risk (Part 2)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The ITT Set – High Risk was defined as all randomly assigned patients to 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. The ITT Set – High Risk consisted of patients in ITT Set who met at least 1 of the high-risk criteria.

    Subject analysis set title
    ITTI Set - High Risk (Part 2)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The ITTI Set - High Risk was defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR who received a complete or partial dose of 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. If the pre-infusion result at Day 1 was confirmed negative or missing and the Day 2 or Day 3 result was confirmed positive, this patient was also considered as confirmed SARS-CoV-2 infection.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set was defined as all randomly assigned patients who received a complete or partial dose of study drug. It was applied for both Part 1 and Part 2.

    Subject analysis set title
    PK Set (Part 1)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PK Set was 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 of RT-qPCR at Day 1 was confirmed negative or missing and the Day 2 result was confirmed positive, this patient was also considered as confirmed SARS-CoV-2 infection.

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

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    End point title
    		 Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) [1] [2]
    End point 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) was used for the analysis. - This primary endpoint was 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.
    End point type
    Primary
    End point timeframe
    Up to Day 28
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses of Part 2 primary endpoint was only specified since Part 1 of the study was exploratory.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1) Placebo group (Part 1)
    Number of subjects analysed
    101
    103
    103
    Units: Subjects
    4
    5
    9
    No statistical analyses for this end point

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

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    End point title
    		 Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) [3] [4]
    End point 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) was used for the analysis. - This supportive primary endpoint was 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.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses of Part 2 primary endpoint was only specified since Part 1 of the study was exploratory.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1) Placebo group (Part 1)
    Number of subjects analysed
    101
    103
    103
    Units: Subjects
        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
    No statistical analyses for this end point

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

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    End point title
    		 Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) [5] [6]
    End point 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) was used for the analysis. - This supportive primary endpoint was to evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses of Part 2 primary endpoint was only specified since Part 1 of the study was exploratory.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1) Placebo group (Part 1)
    Number of subjects analysed
    101
    103
    103
    Units: Days
        median (confidence interval 95%)
    12.75 (9.00 to 12.84)
    11.89 (8.94 to 12.91)
    12.94 (12.75 to 13.99)
    No statistical analyses for this end point

    Primary: Time to Clinical Recovery (Part 1)

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    End point title
    		 Time to Clinical Recovery (Part 1) [7] [8]
    End point 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.) was used for the analysis. - This supportive primary endpoint was to assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses of Part 2 primary endpoint was only specified since Part 1 of the study was exploratory.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1) Placebo group (Part 1)
    Number of subjects analysed
    95
    92
    98
    Units: Days
        median (confidence interval 95%)
    7.18 (5.50 to 9.37)
    7.30 (5.72 to 9.33)
    8.80 (6.88 to 13.09)
    No statistical analyses for this end point

    Primary: 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)

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    End point 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) [9]
    End point 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) was used for the analysis. - This primary endpoint was 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.
    End point type
    Primary
    End point timeframe
    Up to Day 28
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 2 of the study. So, only arms in Part 2 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 2) Placebo group (Part 2)
    Number of subjects analysed
    446
    434
    Units: Subjects
    14
    48
    Statistical analysis title
    		 Statistical analysis of primary endpoint (Part 2)
    Statistical analysis description
    95% stratified Newcombe CI with CMH weights were presented.
    Comparison groups
    CT-P59 40 mg/kg group (Part 2) v Placebo group (Part 2)
    Number of subjects included in analysis
    880
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference % estimated using CMH weights
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -4.5
    Notes
    [10] - 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).

    Secondary: 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)

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    End point 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) [11]
    End point description
    - 1st key seconday endpoint - ITT Set (defined as all randomly assigned patients to the study drug) was used for the analysis. - This key secondary endpoint was 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.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 2 of the study. So, only arms in Part 2 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 2) Placebo group (Part 2)
    Number of subjects analysed
    656
    659
    Units: Subjects
    16
    53
    Statistical analysis title
    		 Statistical analysis of 1st key seconadry endpoint
    Statistical analysis description
    - 95% stratified Newcombe CI with CMH weights were presented. - The first key secondary endpoint was tested after the primary endpoint was statistically significant.
    Comparison groups
    CT-P59 40 mg/kg group (Part 2) v Placebo group (Part 2)
    Number of subjects included in analysis
    1315
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference % estimated using CMH weights
    Point estimate
    -5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 -3.3
    Notes
    [12] - 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).

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

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    End point title
    		 Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) [13]
    End point description
    - 2nd key secondary endpoint - 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) was used for the analysis. - This key secondary endpoint was to assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in high-risk patients. - The median time in Placebo group was not reached as less than 50% of patients achieved clinical recovery. Also, the number of patients achieved clinical recovery in Placebo group was not sufficient to calculate the upper CI. Both results should be recorded as Not Calculated (N.C.) but 14.0 was recorded instead of N.C. as alphabetical letters were not allowed to be recorded into the system.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 2 of the study. So, only arms in Part 2 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 2) Placebo group (Part 2)
    Number of subjects analysed
    429
    406
    Units: Days
        median (confidence interval 95%)
    9.27 (8.27 to 11.05)
    14.0 (12.35 to 14.0)
    Statistical analysis title
    		 Statistical analysis of 2nd key seconadry endpoint
    Statistical analysis description
    - The 2nd key seconadry endpoint was tested after the 1st key secondary endpoint was statistically significant.
    Comparison groups
    CT-P59 40 mg/kg group (Part 2) v Placebo group (Part 2)
    Number of subjects included in analysis
    835
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [14]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 1.9
    Notes
    [14] - P-value was calculated using stratified log-rank test stratified by age (≥60 vs. <60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other).

    Secondary: Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)

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    End point title
    		 Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) [15]
    End point description
    - 3rd key secondary endpoint - ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included) was used for the analysis. - This key secondary endpoint was to assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in all randomized patients. - The number of patients achieved clinical recovery in Placebo group was not sufficient to calculate the upper CI. The result should be recorded as Not Calculated (N.C.) but 14.0 was recorded instead of N.C. as alphabetical letters were not allowed to be recorded into the system.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 2 of the study. So, only arms in Part 2 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 2) Placebo group (Part 2)
    Number of subjects analysed
    629
    618
    Units: Days
        median (confidence interval 95%)
    8.38 (7.91 to 9.33)
    13.25 (11.94 to 14.0)
    Statistical analysis title
    		 Statistical analysis of 3rd key secondary endpoint
    Statistical analysis description
    - The 3rd key seconadry endpoint was tested after the 2nd key secondary endpoint was statistically significant.
    Comparison groups
    CT-P59 40 mg/kg group (Part 2) v Placebo group (Part 2)
    Number of subjects included in analysis
    1247
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [16]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 1.73
    Notes
    [16] - P-value was calculated using stratified log-rank test stratified by age (≥60 vs. <60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other).

    Secondary: Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)

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    End point title
    		 Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)
    End point 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) were used for the analysis. - This secondary endpont was to evaluate the additional efficacy of CT-P59.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 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)
    Number of subjects analysed
    101
    103
    103
    612
    618
    Units: Days
        median (confidence interval 95%)
    12.75 (9.00 to 12.84)
    11.89 (8.94 to 12.91)
    12.94 (12.75 to 13.99)
    11.90 (9.02 to 12.83)
    13.15 (12.97 to 18.80)
    No statistical analyses for this end point

    Other pre-specified: Viral Serology for SARS-CoV-2 Antibody (Part 1 and Part 2)

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    End point title
    		 Viral Serology for SARS-CoV-2 Antibody (Part 1 and Part 2)
    End point description
    - The ITTI 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 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 (or Day 3 for Part 2) was also included) was used for the Part 1 and Part 2 analysis. - This exploratory endpoint was to assess the serology of SARS-CoV-2 antibody (IgG and IgM).
    End point type
    Other pre-specified
    End point timeframe
    Days 1, 7, 14, 28, and 56
    End point values
    		 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)
    Number of subjects analysed
    101
    103
    103
    612
    618
    Units: Subjects
        IgG - Day 1
    0
    6
    3
    45
    35
        IgG - Day 7
    27
    32
    32
    354
    322
        IgG - Day 14
    77
    82
    86
    498
    509
        IgG - Day 28
    84
    94
    91
    535
    548
        IgG - Day 56
    78
    85
    86
    506
    532
        IgM - Day 1
    2
    6
    4
    53
    55
        IgM - Day 7
    38
    43
    49
    362
    332
        IgM - Day 14
    78
    82
    87
    467
    491
        IgM - Day 28
    59
    77
    65
    461
    493
        IgM - Day 56
    39
    54
    51
    407
    441
    No statistical analyses for this end point

    Other pre-specified: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1)

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    End point title
    		 Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1) [17]
    End point 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) was used for the analysis. - This exploratory endpoint was to assess the PK of CT-P59.
    End point type
    Other pre-specified
    End point timeframe
    Throughout the study
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1)
    Number of subjects analysed
    29
    32
    Units: h*μg/mL
        arithmetic mean (standard deviation)
    212460.507 ( 46724.5556 )
    426694.643 ( 121171.182 )
    No statistical analyses for this end point

    Other pre-specified: Maximum Serum Concentration (Cmax) (Part 1)

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    End point title
    		 Maximum Serum Concentration (Cmax) (Part 1) [18]
    End point 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) was used for the analysis. - This exploratory endpoint was to assess the PK of CT-P59.
    End point type
    Other pre-specified
    End point timeframe
    Throughout the study
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1)
    Number of subjects analysed
    29
    32
    Units: μg/mL
        arithmetic mean (standard deviation)
    1016.6 ( 268.97 )
    2007.6 ( 477.97 )
    No statistical analyses for this end point

    Other pre-specified: Terminal Half-life (t1/2) (Part 1)

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    End point title
    		 Terminal Half-life (t1/2) (Part 1) [19]
    End point 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) was used for the analysis. - This exploratory endoint was to assess the PK of CT-P59.
    End point type
    Other pre-specified
    End point timeframe
    Throughout the study
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was analyzed for Part 1 of the study. So, only arms in Part 1 among baseline period arms were reported.
    End point values
    		 CT-P59 40 mg/kg group (Part 1) CT-P59 80 mg/kg group (Part 1)
    Number of subjects analysed
    29
    32
    Units: hour
        arithmetic mean (standard deviation)
    403.916 ( 147.8450 )
    453.442 ( 107.5620 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs/AEs were reported by the investigator from the date patients signed the informed consent form until the last assessment date or End-of-Treatment (EOT) visit, regardless of the relationship to the study drug.
    Adverse event reporting additional 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 reported as an (S)AE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    CT-P59 40 mg/kg group (Part 1)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.

    Reporting group title
    CT-P59 80 mg/kg group (Part 1)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1.

    Reporting group title
    Placebo group (Part 1)
    Reporting group description
    		 Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1.

    Reporting group title
    CT-P59 40 mg/kg group (Part 2)
    Reporting group description
    		 Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1.

    Reporting group title
    Placebo group (Part 2)
    Reporting group description
    		 Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1.

    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)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    6 / 652 (0.92%)
    5 / 650 (0.77%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    0 / 652 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraocular melanoma
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    0 / 652 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    1 / 652 (0.15%)
    0 / 650 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    1 / 652 (0.15%)
    0 / 650 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    1 / 652 (0.15%)
    0 / 650 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Hiatus hernia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    0 / 652 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    0 / 652 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    1 / 652 (0.15%)
    0 / 650 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    1 / 652 (0.15%)
    0 / 650 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    1 / 652 (0.15%)
    0 / 650 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    0 / 652 (0.00%)
    1 / 650 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-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)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 105 (18.10%)
    18 / 110 (16.36%)
    17 / 110 (15.45%)
    119 / 652 (18.25%)
    128 / 650 (19.69%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
    1 / 110 (0.91%)
    19 / 652 (2.91%)
    31 / 650 (4.77%)
         occurrences all number
    0
    2
    1
    22
    34
    Blood creatine phosphokinase increased
         subjects affected / exposed
    5 / 105 (4.76%)
    2 / 110 (1.82%)
    1 / 110 (0.91%)
    14 / 652 (2.15%)
    10 / 650 (1.54%)
         occurrences all number
    5
    2
    1
    14
    10
    C-reactive protein increased
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 110 (0.00%)
    0 / 110 (0.00%)
    18 / 652 (2.76%)
    10 / 650 (1.54%)
         occurrences all number
    1
    0
    0
    18
    10
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
    1 / 110 (0.91%)
    8 / 652 (1.23%)
    20 / 650 (3.08%)
         occurrences all number
    0
    1
    2
    8
    20
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 110 (1.82%)
    0 / 110 (0.00%)
    21 / 652 (3.22%)
    15 / 650 (2.31%)
         occurrences all number
    0
    2
    0
    21
    16
    Inflammatory marker increased
         subjects affected / exposed
    0 / 105 (0.00%)
    3 / 110 (2.73%)
    2 / 110 (1.82%)
    14 / 652 (2.15%)
    17 / 650 (2.62%)
         occurrences all number
    0
    3
    2
    14
    18
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 110 (0.91%)
    0 / 110 (0.00%)
    17 / 652 (2.61%)
    14 / 650 (2.15%)
         occurrences all number
    1
    1
    0
    22
    15
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 110 (0.00%)
    3 / 110 (2.73%)
    0 / 652 (0.00%)
    2 / 650 (0.31%)
         occurrences all number
    0
    0
    4
    0
    2
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    3 / 105 (2.86%)
    3 / 110 (2.73%)
    0 / 110 (0.00%)
    6 / 652 (0.92%)
    12 / 650 (1.85%)
         occurrences all number
    3
    3
    0
    6
    12
    Thrombocytosis
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 110 (0.91%)
    2 / 110 (1.82%)
    11 / 652 (1.69%)
    5 / 650 (0.77%)
         occurrences all number
    3
    1
    2
    11
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 105 (0.00%)
    3 / 110 (2.73%)
    1 / 110 (0.91%)
    0 / 652 (0.00%)
    5 / 650 (0.77%)
         occurrences all number
    0
    3
    1
    0
    5
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    2 / 105 (1.90%)
    2 / 110 (1.82%)
    2 / 110 (1.82%)
    3 / 652 (0.46%)
    3 / 650 (0.46%)
         occurrences all number
    2
    2
    2
    3
    3
    Cystitis
         subjects affected / exposed
    3 / 105 (2.86%)
    2 / 110 (1.82%)
    0 / 110 (0.00%)
    0 / 652 (0.00%)
    1 / 650 (0.15%)
         occurrences all number
    3
    2
    0
    0
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    4 / 105 (3.81%)
    3 / 110 (2.73%)
    2 / 110 (1.82%)
    7 / 652 (1.07%)
    9 / 650 (1.38%)
         occurrences all number
    4
    3
    2
    7
    9
    Hyperglycaemia
         subjects affected / exposed
    2 / 105 (1.90%)
    2 / 110 (1.82%)
    3 / 110 (2.73%)
    12 / 652 (1.84%)
    9 / 650 (1.38%)
         occurrences all number
    2
    2
    4
    12
    9
    Hyperkalaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    3 / 110 (2.73%)
    2 / 110 (1.82%)
    9 / 652 (1.38%)
    6 / 650 (0.92%)
         occurrences all number
    1
    5
    2
    10
    7
    Hypertriglyceridaemia
         subjects affected / exposed
    6 / 105 (5.71%)
    0 / 110 (0.00%)
    3 / 110 (2.73%)
    29 / 652 (4.45%)
    33 / 650 (5.08%)
         occurrences all number
    7
    0
    5
    35
    40

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2020
    - The baseline severity categorization (mild to moderate) and key inclusion criteria (not requiring supplemental oxygen therapy) were added to various sub-sections of the protocol. To give further clarification about the study population, the definition of outpatient used in this study was added. - Based on the FDA recommendation, medically attended visit was deleted from the primary objectives of Part 1 and Part 2. - The word ‘mild’ was deleted from inclusion criterion #3 to match the definition of patient’s condition categorized in both the FDA and WHO guidelines for COVID-19. The condition for enrolling pneumonia patients was added to follow the recommendation from MFDS. - Inclusion criterion #7 was updated to only include patients with a body weight of ≤99.9 kg in the study. - Exclusion criterion #1 was updated - Exclusion criterion #2 was updated to clarify the use of prohibited drugs for chronic HIV infection because the therapeutic effect on HIV patients has not yet been studied. Additional examples of prohibited medications or treatments were added. - Exclusion criterion #5 was updated to delete the BMI limitation of <18 kg/m2. The range of clinical laboratory results of abnormal liver function and renal impairment was extended, considering the characteristics of mild to moderate patients and the dosing regimen of the investigational product (single use). The criterion of uncontrolled hypertension was deleted because the definition of of uncontrolled DM and hypertension can vary by investigator and clinical findings. - The criterion for the possible enrollment of pregnant female participants in Part 2 was deleted. - Sample size calculation was updated to accommodate the deletion of medically attended visit from the primary endpoint, and further explanation for the assumption of sample size was added. - To take into account FDA’s recommendation, the analysis set was updated from ITTI to ITT for primary efficacy analysis.
    19 Oct 2020
    - Amendments initially made in the protocol Version 3.0, including country specific A.0 which needed to be applied in all study centers were applied. - As per HPRA’s recommendation, the review frequency of SAE listings was updated from monthly to biweekly, and an additional description was added to clearly state that an additional DSMB meeting can be called when needed.
    16 Dec 2020
    - The rationale for dose selection was updated as per the clinical updated data of Studies CT-P59 1.1 and 1.2. - To initiate Part 2, dose and infusion time was updated as 40 mg/kg over 60 minutes (± 15 minutes) - Schedule of viral shedding in Part 2 was updated as there were changes in frequency of the test. - Note of exclusion criteria #5b and #5c was added to reduce the time required for the tests and to efficiently operate the study. - How to assess the clinical recovery when a symptom was recorded as ‘absent’ at baseline was added for futher clarification. Consideirng the data from Part 1 which showed that the most of patients had received the study drug during the evening in Part 1, frequecny of writing patient diary and measuring body temperature were changed from twice a day to once a day. - Additional guideline for reporting AEs/SAEs, which any events related to aggravation of COVID were not to be capture as AEs/SAEs, was added. - Number of sampling time point for nasopharyngeal swab in Part 2 was reduced for the sake of patients. - Description of DSMB was separately stated by Parts. - As per the updated plan for the study, the number of CSRs were updated. - Other administrative changes were made
    08 Jan 2021
    - Amendments initially made in the protocol Version 4.1, including country specific A.1, which needed to be applied in all study centers were applied. - The rationale for dose selection was updated as per the clinical updated data of Study CT-59 3.2 Part 1. - Other administrative changes were made.
    22 Mar 2021
    - Primary objective was updated to demonstrate the efficacy of the product in high-risk patients. - Key secondary efficacy endpoints were newly added to assess the efficacy of the product in all randomized patients and high-risk patients. - Sample size of Part 2 was reassessed and updated to include the target number of high-risk patients. - Statistical method for the primary efficacy endpoint of Part 2 was updated to CMH test. - Statistical analysis for key secondary efficacy endpoints were newly added. - Statistical method the secondary efficacy endpoints of Part 2 was updated. - Supportive statistical power calculations for key secondary endpoints were added. - Definition of high-risk patients was newly added. Analysis sets for high-risk were defined. - To achieve the target number of high-risk patients, footnote of proceeding patient enrolment was added. - Number of participating countries and sites in Part 2 were updated - To encourage high-risk patients’ enrolment, the exclusion criteria (#5a, #5b, #5c, #5d, #5e, #5f, and #5g) relevant to high-risk patients were deleted. - As monitoring purpose included those who were not in severe condition but needed to be monitored under hospital setting, monitoring purpose in a hospitalized setting was deleted to take into account FDA’s comment. - Other administrative changes were made
    30 Apr 2021
    - Non-severe pneumonia was deleted from the high-risk criteria as per the recommendation from EMA. - Sample size calculation was updated based on the results from Part 1 of this study and reference data from other companies. - Statistical methods for primary and key secondary endpoints were updated as per the recommendation from FDA. - Amendments made in the protocol Version 6.0, including country specific H.1, were applied.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported.
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