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To Evaluate the Safety and Efficacy of CT-P59 in Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602000
Recruitment Status : Completed
First Posted : October 26, 2020
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
This is 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 safety during after study drug injection.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Biological: CT-P59/Placebo Phase 2 Phase 3

Detailed Description:
CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection
Actual Study Start Date : September 25, 2020
Actual Primary Completion Date : May 21, 2021
Actual Study Completion Date : October 20, 2021


Arm Intervention/treatment
Experimental: CT-P59 Arm 1 & CT-P59 Arm 2 Biological: CT-P59/Placebo
administered

Placebo Comparator: Placebo Biological: CT-P59/Placebo
administered




Primary Outcome Measures :
  1. Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]
    To evaluate the therapeutic efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection.

  2. Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]
    To evaluate the therapeutic efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection.

  3. Time to clinical recovery for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]
    To evaluate the therapeutic efficacy of CT-P59 as of clinical recovery of the patients' SARS-CoV-2 symptoms.

  4. Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 1 (Phase II) [ Time Frame: Up to Day 28 ]
    To evaluate the therapeutic efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection

  5. Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection in high-risk patients for Part 2 (Phase III) [ Time Frame: Up to Day 28 ]
    To evaluate the therapeutic efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection


Secondary Outcome Measures :
  1. Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection

  2. Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection

  3. Proportion of patients with all-cause mortality for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection

  4. Time to clinical recovery for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of clinical recovery of the patients' SARS-CoV-2 symptoms

  5. Duration of fever for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of the duration of fever of the patients

  6. Proportion of patients with hospital admission due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection

  7. Proportion of mechanical ventilation due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection

  8. Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection.

  9. Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection

  10. Proportion of patients requiring rescue therapy due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection

  11. Time to national early warning score 2 (NEWS2) of 0 for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection

  12. Scores of other known SARS-CoV-2 infection symptoms such as vomiting, diarrhea, loss of taste or smell for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection

  13. Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 2 [ Time Frame: Up to Day 28 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection

  14. Time to clinical recovery in high-risk patients for Part 2 [ Time Frame: Up to Day 14 ]
    To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each patient must meet all of the following criteria to be randomized in this study:

  1. Adult male or female patient, aged 18 or above.
  2. Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic testor RT-PCR.
  3. Patient has mild conditions meeting all of the following criteria:

    1. Oxygen saturation ≥ 94% on room air.
    2. Not requiring supplemental oxygen.
  4. Patient who has one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration

Exclusion Criteria:

  1. Patient with severe condition meeting one of the following:

    1. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
    2. Respiratory distress with respiratory rate ≥30 breaths/min.
    3. Requires supplemental oxygen
    4. Experience shock
    5. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
  2. Patient who has received or has a plan to receive any of 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(unless used chronically for autoimmune diseases), dexamethasone, and other immunomodulatory agents and human immunodeficiency virusprotease inhibitorsfor therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
    2. Any SARS-CoV-2 human intravenous 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602000


Locations
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Korea, Republic of
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of, 35015
Sponsors and Collaborators
Celltrion
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04602000    
Other Study ID Numbers: CT-P59 3.2
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases