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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003369-20 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P59 40 mg/kg group (Part 1) | Experimental | CT-P59 (regdanvimab), 40 mg/kg by IV infusion once |
|
| CT-P59 80 mg/kg group (Part 1) | Experimental | CT-P59 (regdanvimab), 80 mg/kg by IV infusion once |
|
| Placebo group (Part 1) | Placebo Comparator | Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once |
|
| CT-P59 40 mg/kg group (Part 2) | Experimental | CT-P59 (regdanvimab), 40 mg/kg by IV infusion once |
|
| Placebo group (Part 2) | Placebo Comparator | Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P59 | Biological | CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to Day 28 |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14 | Up to Day 14 |
| Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14 | Up to Day 14 |
| Time to Clinical Recovery (Part 1) | To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| [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. | Days 1, 7, 14, 28, and 56 |
| [PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1) |
Inclusion Criteria:
Patient had to meet all of the following criteria to be randomized in this study.
Patient was an adult male or female patient, aged 18 or above.
Patient was diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR (reverse transcription-polymerase chain reaction).
Patient with conditions meeting all of the following criteria:
Patient who had an onset of symptom no more than 7 days prior to the study drug administration.
Patient had 1 or more of the SARS-CoV-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration.
Exclusion Criteria:
Patients meeting any of the following criteria were excluded from the study.
Patient had current severe condition meeting one of the following:
Patient had received or had a plan to receive any of the following prohibited medications or treatments:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Jung-gu | 35015 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36043180 | Derived | Kim JY, Sandulescu O, Preotescu LL, Rivera-Martinez NE, Dobryanska M, Birlutiu V, Miftode EG, Gaibu N, Caliman-Sturdza O, Florescu SA, Shi HJ, Streinu-Cercel A, Streinu-Cercel A, Lee SJ, Kim SH, Chang I, Bae YJ, Suh JH, Chung DR, Kim SJ, Kim MR, Lee SG, Park G, Eom JS. A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Aug 8;9(8):ofac406. doi: 10.1093/ofid/ofac406. eCollection 2022 Aug. | |
| 35713300 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P59 40 mg/kg Group (Part 1) | Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. |
| FG001 | CT-P59 80 mg/kg Group (Part 1) | Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. |
| FG002 | Placebo Group (Part 1) | Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. |
| FG003 | CT-P59 40 mg/kg Group (Part 2) | Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. |
| FG004 | Placebo Group (Part 2) | Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | CT-P59 80 mg/kg Group (Part 1) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
|
Adverse events (AEs) and serious adverse events (SAEs) were reported by the investigator from the date patients signed the informed consent form (ICF) until the last assessment date or End-of-Treatment (EOT) visit (Period: day of ICF signed to Day 90[EOT]), regardless of the relationship to the study drug.
The investigator was responsible for reporting all AEs that were observed or reported from signing of ICF to EOT, regardless of their relationship to study drug or their clinical significance.
Cases of worsening of SARS-CoV-2 infection which were considered as unrelated to the study drug were not collected and not reported as an (S)AE.
The analysis population is Safety Set and it is defined as all randomly assigned patients who received a complete or partial dose of the study drug.
All-cause
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P59 40 mg/kg Group (Part 1) | Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yun Ju Bae / Head of Clinical Planning 1 Department | Celltrion, Inc | +82 32 850 4160 | YunJu.Bae@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2021 | Jun 9, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Part 1 | Jul 22, 2021 | Jun 22, 2022 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Part 2 | Dec 16, 2021 | Jun 22, 2022 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000716788 | regdanvimab |
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| CT-P59 | Biological | CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) |
|
|
| Placebo | Biological | Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1) |
|
| CT-P59 | Biological | CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2) |
|
|
| Placebo | Biological | Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2) |
|
| 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 | Up to Day 28 |
| Up to Day 28 |
| Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) | To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in high-risk patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. | Up to Day 14 |
| Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) | To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in all randomized patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. | Up to Day 14 |
| Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Up to Day 28 |
| Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | Days 3, 7, 10, 14, 21, and 28 |
| Time to Clinical Recovery (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent [0], mild [1]. moderate [2], and severe [3]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. | Up to Day 28 |
To assess the PK of CT-P59 |
| Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion |
| [PK] Maximum Serum Concentration (Cmax) (Part 1) | To assess the PK of CT-P59 | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion |
| [PK] Terminal Half-life (t1/2) (Part 1) | To assess the PK of CT-P59 | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion |
| Derived |
| Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2. |
| 35295819 | Derived | Streinu-Cercel A, Sandulescu O, Preotescu LL, Kim JY, Kim YS, Cheon S, Jang YR, Lee SJ, Kim SH, Chang I, Suh JH, Lee SG, Kim MR, Chung DR, Kim HN, Streinu-Cercel A, Eom JS. Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Feb 2;9(4):ofac053. doi: 10.1093/ofid/ofac053. eCollection 2022 Apr. |
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| Physician Decision |
|
| Death |
|
| Lost to Follow-up |
|
| Other |
|
| Completed Treatment Period but not entered into Follow-up Period |
|
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)
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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) |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | CT-P59 80 mg/kg Group (Part 1) | Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. |
| OG002 | Placebo Group (Part 1) | Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. |
|
|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 14 |
|
|
|
| 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 | 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) | Posted | Median | 95% Confidence Interval | days | Up to Day 14 |
|
|
|
| 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. | 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.) | Posted | Median | 95% Confidence Interval | days | Up to Day 14 |
|
|
|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
|
|
| 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 | ITT Set (defined as all randomly assigned patients to the study drug) | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
|
| 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. | 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) | Posted | Median | 95% Confidence Interval | days | Up to Day 14 |
|
|
|
| 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. | ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included) | Posted | Median | 95% Confidence Interval | days | Up to Day 14 |
|
|
|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
|
| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
|
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| 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 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
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| Secondary | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | To evaluate the additional efficacy of CT-P59 | 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) | Posted | Count of Participants | Participants | Up to Day 28 |
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| 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 | 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) | Posted | Median | 95% Confidence Interval | days | Up to Day 28 |
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| 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 | 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) | Posted | Count of Participants | Participants | Days 3, 7, 10, 14, 21, and 28 |
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| 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. | 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) | Posted | Median | 95% Confidence Interval | days | Up to Day 28 |
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| 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. | 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. | Posted | Count of Participants | Participants | Days 1, 7, 14, 28, and 56 |
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| 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 | 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) | Posted | Mean | Standard Deviation | h*μg/mL | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion |
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| Other Pre-specified | [PK] Maximum Serum Concentration (Cmax) (Part 1) | To assess the PK of CT-P59 | 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) | Posted | Mean | Standard Deviation | μg/mL | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion |
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| Other Pre-specified | [PK] Terminal Half-life (t1/2) (Part 1) | To assess the PK of CT-P59 | 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) | Posted | Mean | Standard Deviation | h | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion |
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| 0 |
| 105 |
| 0 |
| 105 |
| 19 |
| 105 |
| EG001 | CT-P59 80 mg/kg Group (Part 1) | Each participant received CT-P59 (regdanvimab) 80 mg/kg by IV infusion on Day 1. | 0 | 110 | 0 | 110 | 18 | 110 |
| EG002 | Placebo Group (Part 1) | Each participant received placebo, matching in volume of CT-P59 80 mg/kg, by IV infusion on Day 1. | 0 | 110 | 0 | 110 | 17 | 110 |
| EG003 | CT-P59 40 mg/kg Group (Part 2) | Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. | 1 | 652 | 6 | 652 | 119 | 652 |
| EG004 | Placebo Group (Part 2) | Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1. | 2 | 650 | 5 | 650 | 128 | 650 |
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Intraocular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Inflammatory marker increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 10 |
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| Day 14 |
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| Day 7 |
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| Day 10 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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| IgG - Day 7 |
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| IgG - Day 14 |
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| IgG - Day 28 |
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| IgG - Day 56 |
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| IgM - Day 1 |
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| IgM - Day 7 |
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| IgM - Day 14 |
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| IgM - Day 28 |
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| IgM - Day 56 |
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