SARS-CoV-2 Infection
Conditions
Brief summary
This was a Phase 2/3 study to assess the efficacy about therapeutic effect of CT-P59 to the mild to moderate SARS-CoV-2 infected patients and the safety during after study drug injection.
Detailed description
CT-P59 is a human monoclonal antibody targeted against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein as a treatment for SARS-CoV-2 infection, which is manufactured by recombinant deoxyribonucleic acid technology in a Chinese hamster ovary mammalian cell line. This Phase 2/3, randomized, parallel-group, placebo-controlled, double-blind study was designed to evaluate the safety, tolerability, and therapeutic potential of CT-P59 in outpatients with mild to moderate SARS-CoV-2 infection, not requiring supplemental oxygen therapy.
Interventions
BIOLOGICALCT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
BIOLOGICALPlacebo
Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 1. Oxygen saturation \> 94% on room air. 2. Not requiring supplemental oxygen. 4. Patient who had an onset of symptom no more than 7 days prior to the study drug administration. 5. 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: 1. Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions. 2. Respiratory distress with respiratory rate ≥30 breaths/min. 3. Required supplemental oxygen 4. Experienced shock 5. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion. 2. Patient had received or had a plan to receive any of the following prohibited medications or treatments: 1. 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 2. Any SARS-CoV-2 human IV immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration 3. 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 4. Use of medications that are contraindicated with SoC 5. SARS-CoV-2 vaccine prior to the study drug administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | Up to Day 28 | To evaluate the additional efficacy of CT-P59 |
| Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | Up to Day 28 | To evaluate the additional efficacy of CT-P59 |
| Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Days 3, 7, 10, 14, 21, and 28 | To evaluate the additional efficacy of CT-P59 |
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| [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. |
| [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 |
| [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 |
| [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 |
Countries
South Korea
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| CT-P59 40 mg/kg Group (Part 1) 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) | 105 |
| CT-P59 80 mg/kg Group (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) | 111 |
| Placebo Group (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) | 111 |
| CT-P59 40 mg/kg Group (Part 2) 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) | 656 |
| Placebo Group (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) | 659 |
| Total | 1,642 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Completed Treatment Period but not entered into Follow-up Period | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 1 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 3 | 4 |
| Overall Study | Other | 4 | 1 | 2 | 5 | 4 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 6 | 3 | 27 | 39 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 7 Participants |
| Age, Categorical >=65 years | 15 Participants | 21 Participants | 18 Participants | 93 Participants | 78 Participants | 225 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 90 Participants | 93 Participants | 562 Participants | 576 Participants | 1410 Participants |
| Age, Continuous | 51.0 years | 51.0 years | 52.0 years | 49.0 years | 47.0 years | 49.0 years |
| Race/Ethnicity, Customized African American/Black | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized American Indian/Alaska native | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 15 Participants | 15 Participants | 7 Participants | 7 Participants | 55 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not allowed by investigator country regulations | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 74 Participants | 73 Participants | 147 Participants |
| Race/Ethnicity, Customized White | 94 Participants | 96 Participants | 96 Participants | 563 Participants | 569 Participants | 1418 Participants |
| Region of Enrollment Hungary | 0 participants | 0 participants | 0 participants | 25 participants | 32 participants | 57 participants |
| Region of Enrollment Italy | 0 participants | 0 participants | 0 participants | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Mexico | 0 participants | 0 participants | 0 participants | 68 participants | 70 participants | 138 participants |
| Region of Enrollment Moldova | 0 participants | 0 participants | 0 participants | 19 participants | 18 participants | 37 participants |
| Region of Enrollment North Macedonia | 0 participants | 0 participants | 0 participants | 30 participants | 26 participants | 56 participants |
| Region of Enrollment Peru | 0 participants | 0 participants | 0 participants | 11 participants | 9 participants | 20 participants |
| Region of Enrollment Poland | 0 participants | 0 participants | 0 participants | 43 participants | 47 participants | 90 participants |
| Region of Enrollment Romania | 93 participants | 90 participants | 93 participants | 315 participants | 311 participants | 902 participants |
| Region of Enrollment Serbia | 0 participants | 0 participants | 0 participants | 23 participants | 24 participants | 47 participants |
| Region of Enrollment South Korea | 11 participants | 15 participants | 14 participants | 6 participants | 6 participants | 52 participants |
| Region of Enrollment Spain | 0 participants | 2 participants | 1 participants | 7 participants | 14 participants | 24 participants |
| Region of Enrollment Ukraine | 0 participants | 0 participants | 0 participants | 58 participants | 49 participants | 107 participants |
| Region of Enrollment United States | 1 participants | 4 participants | 3 participants | 49 participants | 51 participants | 108 participants |
| Sex: Female, Male Female | 46 Participants | 52 Participants | 63 Participants | 309 Participants | 332 Participants | 802 Participants |
| Sex: Female, Male Male | 59 Participants | 59 Participants | 48 Participants | 347 Participants | 327 Participants | 840 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 110 | 0 / 110 | 1 / 652 | 2 / 650 |
| other Total, other adverse events | 19 / 105 | 18 / 110 | 17 / 110 | 119 / 652 | 128 / 650 |
| serious Total, serious adverse events | 0 / 105 | 0 / 110 | 0 / 110 | 6 / 652 | 5 / 650 |
Outcome results
Primary
Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)
To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | 4 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | 5 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | 9 Participants |
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)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 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 High-risk Patients (Part 2) | 14 Participants |
| CT-P59 80 mg/kg Group (Part 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 High-risk Patients (Part 2) | 48 Participants |
p-value: <0.000195% CI: [-11.7, -4.5]Cochran-Mantel-Haenszel
Primary
Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)
To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14
Time frame: Up to Day 14
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 4 | 2 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 2 | 0 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 5 | 7 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 14 | 23 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 3 | 4 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 6 | 5 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 10 | 19 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 7 | 8 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 3 | 4 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 7 | 12 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 2 | 1 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 10 | 18 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 14 | 19 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 4 | 6 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 5 | 3 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 6 | 5 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 5 | 2 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 2 | 0 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 3 | 3 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 4 | 4 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 14 | 23 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 6 | 4 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 7 | 7 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Day 10 | 19 Participants |
Primary
Time to Clinical Recovery (Part 1)
To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms absent in intensity at baseline should maintain as absent for at least 48 hours.
Time frame: Up to Day 14
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Time to Clinical Recovery (Part 1) | 7.18 days |
| CT-P59 80 mg/kg Group (Part 1) | Time to Clinical Recovery (Part 1) | 7.30 days |
| Placebo Group (Part 1) | Time to Clinical Recovery (Part 1) | 8.80 days |
Primary
Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)
To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14
Time frame: Up to Day 14
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | 12.75 days |
| CT-P59 80 mg/kg Group (Part 1) | Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | 11.89 days |
| Placebo Group (Part 1) | Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | 12.94 days |
Secondary
Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 7 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 11 Participants |
| Placebo Group (Part 1) | Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 15 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 37 Participants |
| Placebo Group (Part 2) | Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 85 Participants |
Secondary
Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 4 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 4 Participants |
| Placebo Group (Part 1) | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 9 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 15 Participants |
| Placebo Group (Part 2) | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 49 Participants |
Secondary
Proportion of Patients With All-cause Mortality (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | 0 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | 0 Participants |
| Placebo Group (Part 1) | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | 0 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | 1 Participants |
| Placebo Group (Part 2) | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | 2 Participants |
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)
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
Population: ITT Set (defined as all randomly assigned patients to the study drug)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 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) | 16 Participants |
| CT-P59 80 mg/kg Group (Part 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) | 53 Participants |
Secondary
Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 4 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 5 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 9 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 16 Participants |
| Placebo Group (Part 2) | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 52 Participants |
Secondary
Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| Placebo Group (Part 2) | Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 5 Participants |
Secondary
Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 1 Participants |
| Placebo Group (Part 1) | Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 0 Participants |
| Placebo Group (Part 2) | Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | 3 Participants |
Secondary
Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Days 3, 7, 10, 14, 21, and 28
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 3 | 4 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 7 | 8 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 21 | 10 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 14 | 23 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 28 | 6 Participants |
| CT-P59 40 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 10 | 19 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 3 | 4 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 21 | 8 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 7 | 12 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 28 | 5 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 10 | 18 Participants |
| CT-P59 80 mg/kg Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 14 | 19 Participants |
| Placebo Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 14 | 23 Participants |
| Placebo Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 3 | 3 Participants |
| Placebo Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 10 | 19 Participants |
| Placebo Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 7 | 7 Participants |
| Placebo Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 28 | 5 Participants |
| Placebo Group (Part 1) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 21 | 9 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 10 | 137 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 3 | 34 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 7 | 141 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 14 | 113 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 21 | 99 Participants |
| CT-P59 40 mg/kg Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 28 | 52 Participants |
| Placebo Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 21 | 117 Participants |
| Placebo Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 10 | 117 Participants |
| Placebo Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 7 | 94 Participants |
| Placebo Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 3 | 21 Participants |
| Placebo Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 14 | 149 Participants |
| Placebo Group (Part 2) | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Day 28 | 61 Participants |
Secondary
Time to Clinical Recovery (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms absent in intensity at baseline should maintain as absent for at least 48 hours.
Time frame: Up to Day 28
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Time to Clinical Recovery (Part 1 and Part 2) | 7.18 days |
| CT-P59 80 mg/kg Group (Part 1) | Time to Clinical Recovery (Part 1 and Part 2) | 7.30 days |
| Placebo Group (Part 1) | Time to Clinical Recovery (Part 1 and Part 2) | 8.80 days |
| CT-P59 40 mg/kg Group (Part 2) | Time to Clinical Recovery (Part 1 and Part 2) | 8.39 days |
| Placebo Group (Part 2) | Time to Clinical Recovery (Part 1 and Part 2) | 13.29 days |
Secondary
Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)
To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in all randomized patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms absent in intensity at baseline should maintain as absent for at least 48 hours.
Time frame: Up to Day 14
Population: ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) | 8.38 days |
| CT-P59 80 mg/kg Group (Part 1) | Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) | 13.25 days |
Secondary
Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)
To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in high-risk patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms absent in intensity at baseline should maintain as absent for at least 48 hours.
Time frame: Up to Day 14
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) | 9.27 days |
| CT-P59 80 mg/kg Group (Part 1) | Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) | NA days |
Secondary
Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2)
To evaluate the additional efficacy of CT-P59
Time frame: Up to Day 28
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | 12.75 days |
| CT-P59 80 mg/kg Group (Part 1) | Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | 11.89 days |
| Placebo Group (Part 1) | Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | 12.94 days |
| CT-P59 40 mg/kg Group (Part 2) | Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | 11.90 days |
| Placebo Group (Part 2) | Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | 13.15 days |
Other Pre-specified
[PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | [PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1) | 212460.507 h*μg/mL | Standard Deviation 46724.5556 |
| CT-P59 80 mg/kg Group (Part 1) | [PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1) | 426694.643 h*μg/mL | Standard Deviation 121171.182 |
Other Pre-specified
[PK] Maximum Serum Concentration (Cmax) (Part 1)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | [PK] Maximum Serum Concentration (Cmax) (Part 1) | 1016.6 μg/mL | Standard Deviation 268.97 |
| CT-P59 80 mg/kg Group (Part 1) | [PK] Maximum Serum Concentration (Cmax) (Part 1) | 2007.6 μg/mL | Standard Deviation 477.97 |
Other Pre-specified
[PK] Terminal Half-life (t1/2) (Part 1)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | [PK] Terminal Half-life (t1/2) (Part 1) | 403.916 h | Standard Deviation 147.845 |
| CT-P59 80 mg/kg Group (Part 1) | [PK] Terminal Half-life (t1/2) (Part 1) | 453.442 h | Standard Deviation 107.562 |
Other Pre-specified
[Virology] Viral Serology for SARS-CoV-2 Antibody
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 7 | 38 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 1 | 2 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 14 | 77 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 56 | 39 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 56 | 78 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 28 | 59 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 14 | 78 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 7 | 27 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 1 | 0 Participants |
| CT-P59 40 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 28 | 84 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 7 | 43 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 28 | 94 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 1 | 6 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 7 | 32 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 14 | 82 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 56 | 85 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 1 | 6 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 14 | 82 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 28 | 77 Participants |
| CT-P59 80 mg/kg Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 56 | 54 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 1 | 3 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 7 | 32 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 7 | 49 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 28 | 91 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 56 | 86 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 28 | 65 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 56 | 51 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 14 | 87 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 14 | 86 Participants |
| Placebo Group (Part 1) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 1 | 4 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 7 | 354 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 56 | 407 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 28 | 461 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 1 | 53 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 14 | 498 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 28 | 535 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 1 | 45 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 7 | 362 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 56 | 506 Participants |
| CT-P59 40 mg/kg Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 14 | 467 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 28 | 548 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 56 | 532 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 7 | 322 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 56 | 441 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 1 | 55 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 7 | 332 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 1 | 35 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 14 | 491 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgM - Day 28 | 493 Participants |
| Placebo Group (Part 2) | [Virology] Viral Serology for SARS-CoV-2 Antibody | IgG - Day 14 | 509 Participants |