To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CT-P63 and CT-P66 / Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Adult male or female patient, aged 18 or above.
- Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
Patient with conditions meeting all of the following criteria:
- Oxygen saturation ≥ 94% on room air.
- Not requiring supplemental oxygen.
- Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.
Exclusion Criteria:
Patient with current serious condition meeting one of the following:
- Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
- Respiratory distress with respiratory rate ≥30 breaths/min.
- Severe pneumonia
- Requires supplemental oxygen
- Experience shock
- Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
Patient who has received or has a plan to receive any of 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 nirmatrelvir and ritonavir, molnupiravir, remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), and other immunomodulatory agents and human immunodeficiency virus protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
- Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 infection prior to study drug administration
- Any approved monoclonal antibody (sotrovimab, casirivimab and imdevimab, bamlanivimab and etesevimab, etc), 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 COVID-19 infection prior to the first study drug administration.
- Any investigational vaccine for SARS-CoV-2.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CT-P63 and CT-P66
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time to clinical recovery
To evaluate the therapeutic efficacy of CT-P63 and CT-P66 combination therapy as of clinical recovery of the patients' COVID-19 symptoms.
Secondary Outcome Measures
Overall safety
To evaluate overall safety of inhaled CT-P63 and CT-P66
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05224856
Brief Title
To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen
Official Title
A Phase 3, Randomized, Parallel-group, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With Coronavirus Disease 2019 (COVID-19) Not Requiring Supplemental Oxygen
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor has decided to stop development of the inhaled CT-P63/66 combination therapy.
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety.
Detailed Description
CT-P63 and CT-P66 are monoclonal antibodies targeted against SARS-CoV-2 spike receptor binding domain as a treatment for COVID-19 infection. CT-P63 and CT-P66 are currently being developed by the Sponsor as a potential treatment for COVID-19 infection. In this study, efficacy, safety, and virology of inhaled CT-P63 and CT-P66 will be evaluated in symptomatic patients with COVID-19 Infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P63 and CT-P66
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CT-P63 and CT-P66 / Placebo
Intervention Description
Inhalation
Primary Outcome Measure Information:
Title
Time to clinical recovery
Description
To evaluate the therapeutic efficacy of CT-P63 and CT-P66 combination therapy as of clinical recovery of the patients' COVID-19 symptoms.
Time Frame
Up to Day 14
Secondary Outcome Measure Information:
Title
Overall safety
Description
To evaluate overall safety of inhaled CT-P63 and CT-P66
Time Frame
Up to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female patient, aged 18 or above.
Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
Patient with conditions meeting all of the following criteria:
Oxygen saturation ≥ 94% on room air.
Not requiring supplemental oxygen.
Patient who has onset of one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration.
Exclusion Criteria:
Patient with current serious condition meeting one of the following:
Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
Respiratory distress with respiratory rate ≥30 breaths/min.
Severe pneumonia
Requires supplemental oxygen
Experience shock
Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
Patient who has received or has a plan to receive any of 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 nirmatrelvir and ritonavir, molnupiravir, remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), and other immunomodulatory agents and human immunodeficiency virus protease inhibitors for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of COVID-19 infection prior to study drug administration
Any approved monoclonal antibody (sotrovimab, casirivimab and imdevimab, bamlanivimab and etesevimab, etc), 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 COVID-19 infection prior to the first study drug administration.
Any investigational vaccine for SARS-CoV-2.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen
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