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

• ClinicalTrials.gov Identifier: NCT04602000
• Recruitment Status: Recruiting
• First Posted: October 26, 2020
• Last Update Posted: October 26, 2020
• Sponsor: Celltrion
• Information provided by (Responsible Party): Celltrion

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: ChangWoo Park; 82-32-850-5701; ChangWoo.Park@celltrion.com

Contact: JiWoong Lim; 82 32 850 5702; JiWoong.Lim@celltrion.com

Locations

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

More Information

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT04602000
• Other Study ID Numbers: CT-P59 3.2
• First Posted: October 26, 2020
• Last Update Posted: October 26, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection; Severe Acute Respiratory Syndrome; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases