Novel severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection MedDRA version: 23.0 Level: PT Classification code 10084271 Term: SARS-CoV-2 test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Code: CT-P59
Pharmaceutical Form: Solution for infusion
Current Sponsor code: CT-P59
Other descriptive name: CT-P59
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentratio
Sponsors
CELLTRION, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient is male or female aged 18 years or older. 2.Patient has local laboratory confirmation of SARS-CoV-2 infection by RT-PCR from the upper or lower respiratory tract specimens no more than 4 days prior to the administration of the study drug. Note: If there is available test result confirmed as SARS-CoV-2 infection prior to obtaining written informed consent (but no more than 4 days prior to the administration of the study drug) and that result was from the RT-PCR by the upper or lower respiratory tract specimen, that test result can be allowed. Note: During the screening period, only one re-test for RT-PCR will be allowed if study drug can be administered no more than 10 days from onset of symptom based on re-test results. 3.Onset of symptom no more than 10 days prior to the administration of the study drug. 4.Patient with conditions meeting the following criteria, and currently hospitalized (or will be hospitalized prior to the administration of the study drug): a)Oxygen saturation = 94% on room air and/or PaO2/FiO2 ratio = 300 mgHg, AND b)Requiring supplemental oxygen. 5.Patient with abnormal radiographic findings in lung suggestive of SARS-CoV-2 infection by investigator’s discretion. 6.Patient's weight is of = 99.9 kg. 7.Patient and/or their legally authorized representative must be informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the informed consent form (ICF) before any study specific procedures. 8.Patient and their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study (up to 6 months after the study drug administration) as specified in Section 6.2.2.7. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Patient who is requiring extracorporeal membrane oxygenation (ECMO), or invasive mechanical ventilation. 2.Patient had a history of and/or concurrent use of medications including any therapy of following(s): a)Drugs with possible anti-SARS-CoV-2 activity or immunomodulators including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (alternative corticosteroids to dexamethasone), tocilizumab, sarilumab, and other immunomodulatory agents and human immunodeficiency virus (HIV) protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to the study drug administration. Note: During the study, authorized drugs (or drugs approved for emergency use) against SARS-CoV-2 infection such as remdesivir or dexamethasone (alternative corticosteroids to dexamethasone), could be used by investigator’s discretion considering the local practice where there is available supply b)Any SARS-CoV-2 human intravenous immunoglobulin (hIVIG), convalescent plasma from a person who recovered from SARS-CoV-2 infection or SARS-CoV-2 nMAb for the treatment of SARS-CoV-2 infection prior to the study drug administration. c)Any other investigational device or medical product including but not limited to any monoclonal antibody, fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration. d)Use of medications that are contraindicated with SoC. e)SARS-CoV-2 vaccine prior to the study drug administration. 3.Patient has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug. 4.Patient has a history of and/or current disease or medical condition including any of following(s): a)Any active malignancy. b)Known severe liver disease (e.g., cirrhosis, or an Alanine Aminotransferase [ALT] level >5 × upper limit of normal [ULN], or an Aspartate Aminotransferase [AST] level >5 × the ULN). c)Renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. d)Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this study, including any past or concurrent conditions that would preclude randomization to one or more of the assigned treatment groups. e)Stroke or myocardial infarction, which is suspected to be related to SARS-CoV-2 infection after the onset of symptom. f)Documented current infection with HIV, hepatitis B or hepatitis C. 5.Patient who has received any other investigational device or medical product within 4 weeks prior to the study drug administration or 5 half-lives, whichever is longer. 6.Patient currently abuses alcohol or drugs. 7.Patient is not eligible for the study participation for whatever reason (including clinical laboratory results) in the opinion of the investigator, or shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate informed consent, or limited the ability of the patient to comply with the protocol requirements in the opinion of the investigator, or unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study, or is unable to give written informed consent or to comply fully with the protocol. 8.Anticipated transfer to another hospital which is n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 To assess that CT-P59 has the potential therapeutic efficacy relative to Placebo as determined by time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2, or 3 on the 8-point ordinal scale for 7 days. Part 2 To demonstrate that CT-P59 has the clinical meaningful therapeutic efficacy relative to Placebo as determined by the time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2, or 3 on the 8-point ordinal scale for 7 days. ;Secondary Objective: Part 1 To evaluate overall safety of CT P59 Part 2 To evaluate the additional efficacy of CT-P59 To evaluate overall safety of CT P59, including immunogenicity and potential effects on the incidence of antibody-dependent enhancement (ADE) ;Primary end point(s): Primary Endpoints The 8-point ordinal scale will be evaluated as primary endpoint (Section 6.1.1); - Time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2 or 3 on the 8-point ordinal scale for 7 days. ;Timepoint(s) of evaluation of this end point: Day 14 Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy and safety endpoints will be analyzed throughout the study. The following parameters for the study drug will be determined as secondary endpoints: •Proportion of recovered patients on Day 7, 14 and 28 •Proportion of intensive care unit transfer on Day 14 and 28 •Mortality rate on Day 14, 28 and 90 •Clinical status by the 8-point ordinal scale on Day 7, 14 and 28 •Time to improvement of at least 1 point from the status at baseline by 8-point ordinal scale up to Day 28 •Change from baseline of the 8-point ordinal scale on Day 7, 14 and 28 •Duration of hospitalization in survivors up to Day 28 •Number of free days of supplemental oxygen up to Day 28 •Proportion of new mechanical ventilation use on Day 14 and 28 •Change from baseline of National Early Warning Score (NEWS) on Day 7, 14 and 28 Safety endpoints: The safety endpoints will be assessed using the followings: AEs (including SAEs and AESI), potential effects on the incidence of ADE, immunogenicity, vital signs, hypersensitivity monitoring, ECG findings, SARS-CoV-2 infection related signs and symptoms, radiography (chest x-ray or chest CT), physical examination findings, clinical laboratory tests, pregnancy tests, and prior and concomitant medications. ;Timepoint(s) of evaluation of this end point: Day 7 Day 14 Day 28 | — |
Countries
Brazil, Bulgaria, Germany, India, Italy, Korea, Republic of, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Sweden, Ukraine, United States
Contacts
Public ContactSung Hyun Kim
CELLTRION, Inc.
Outcome results
None listed