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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With SARS-CoV-2 Infection

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Biological: CT-P59
* Biological: CT-P59
* Biological: Placebo
* Biological: CT-P59
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient had to meet all of the following criteria to be randomized in this study. Patient was an adult male or female patient, aged 18 or above. Patient was diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR (reverse transcription-polymerase chain reaction). Patient with conditions meeting all of the following criteria: Oxygen saturation > 94% on room air. Not requiring supplemental oxygen. Patient who had an onset of symptom no more than 7 days prior to the study drug administration. Patient had 1 or more of the SARS-CoV-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration. Exclusion Criteria: Patients meeting any of the following criteria were excluded from the study. Patient had current severe condition meeting one of the following: Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions. Respiratory distress with respiratory rate ≥30 breaths/min. Required supplemental oxygen Experienced shock Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion. Patient had received or had a plan to receive any of the following prohibited medications or treatments: Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration Any SARS-CoV-2 human IV immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration Use of medications that are contraindicated with SoC SARS-CoV-2 vaccine prior to the study drug administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P59 40 mg/kg group (Part 1)<br>CT-P59 (regdanvimab), 40 mg/kg by IV infusion once | Biological: CT-P59<br>* CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)<br>* Other names: regdanvimab;|
| Experimental: CT-P59 80 mg/kg group (Part 1)<br>CT-P59 (regdanvimab), 80 mg/kg by IV infusion once | Biological: CT-P59<br>* CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)<br>* Other names: regdanvimab;|
| Placebo Comparator: Placebo group (Part 1)<br>Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once | Biological: Placebo<br>* Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)<br>|
| Experimental: CT-P59 40 mg/kg group (Part 2)<br>CT-P59 (regdanvimab), 40 mg/kg by IV infusion once | Biological: CT-P59<br>* CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)<br>* Other names: regdanvimab;|
| Placebo Comparator: Placebo group (Part 2)<br>Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once | Biological: Placebo<br>* Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |