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Trial record 2 of 3 for:    Covid19 | CT-P59

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

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ClinicalTrials.gov Identifier: NCT04602000
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
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)
Estimated Enrollment : 1020 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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

Experimental: CT-P59 Arm 2 Biological: CT-P59/Placebo
administered

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




Primary Outcome Measures :
  1. To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]
    Proportion of patient with negative conversion in nasopharyngeal swab specimen based on reverse transcription quantitative polymerase chain reaction(RT-qPCR)or cell culture at each visit.

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

  3. To evaluate the therapeutic efficacy CT-P59 for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]
    Time to clinical recovery

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

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


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

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

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

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

  5. To evaluate the overall efficacy of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 14 and 28 ]
    Duration of fever defined as the last day in the patient diary on which the temperature >38°C (100.4°F) is recorded, or a potentially antipyretic drug (acetaminophen or ibuprofen) is taken

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

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

  8. To evaluate the overall efficacy of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 14 and 28 ]
    Proportion of patients requiring additional prescription medication due to SARS-CoV-2 infection

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

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

  11. To evaluate the overall safety of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 90 ]
    Proportion of patients reporting Adverse events (AEs, including serious adverse events)

  12. To evaluate the overall safety of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 90 ]
    Proportion of patients reporting Adverse events of special interest (Infusion related reactions, hypersensitivity and anaphylactic reactions)

  13. To evaluate the overall safety of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 90 ]
    Incidence of ADE (Antibody Dependent Enhancement)

  14. To evaluate the overall safety of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 90 ]
    Proportion of patients with anti-drug antibodies Immunogenicity

  15. To evaluate the overall safety of CT-P59 for Part 1 and 2 [ Time Frame: Up to Day 90 ]
    Proportion of patients with anti-drug antibodies S evere Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection related signs and symptoms.

  16. To evaluate virology for part 1 and part 2 [ Time Frame: Up to Day 90 ]
    Viral shedding in nasopharyngeal swab specimen based on RT-qPCR and cell culture

  17. To evaluate virology for part 1 and part 2 [ Time Frame: Up to Day 90 ]
    Genotype and phenotype of SARS-CoV-2 viral isolates

  18. To evaluate virology for part 1 and part 2 [ Time Frame: Up to Day 90 ]
    Viral serology for SARS-CoV-2 antibody



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 following(but not limited to)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. Previous 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 intravenousimmunoglobulin, 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


Contacts
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Contact: ChangWoo Park 82-32-850-5701 ChangWoo.Park@celltrion.com
Contact: JiWoong Lim 82 32 850 5702 JiWoong.Lim@celltrion.com

Locations
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Korea, Republic of
Chungnam National University Hospital Recruiting
Daejeon, Jung-gu, Korea, Republic of, 35015
Contact: Yeon-Sook Kim, MD, PhD    +82-42-280-8109    idalicekim@gmail.com   
Sponsors and Collaborators
Celltrion
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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: October 26, 2020
Last Verified: October 2020
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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Infection
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases