This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)

NCT04593641 | Completed Phase 1 Results DMC

• 2 other identifiers: CT-P59 1.22020-003165-19
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (4)

• Number of Patients With TEAEs

  Up to Day 14

• Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)

  Up to Day 14

• Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)

  Up to Day 14

• Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)

  Up to Day 14

Secondary Outcomes (18)

• The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)

  At Day 28

• Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

  Up to Day 28

• Area Under the Concentration-time Curve of Viral Titers for qPCR

  Up to Day 28

• Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

  Up to Day 28

• Number of Patients With Clinical Recovery

  Up to Day 28

Study Arms (3)

Cohort 1 will receive a dose of CT-P59 or matching placebo

EXPERIMENTAL

Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Biological: CT-P59

Cohort 2 will receive a dose of CT-P59 or matching placebo

EXPERIMENTAL

Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Biological: CT-P59

Cohort 3 will receive a dose of CT-P59 or matching placebo

EXPERIMENTAL

Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Biological: CT-P59

Interventions

CT-P59 BIOLOGICAL

administered

Cohort 1 will receive a dose of CT-P59 or matching placebo; Cohort 2 will receive a dose of CT-P59 or matching placebo; Cohort 3 will receive a dose of CT-P59 or matching placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Each patient must meet all of the following criteria to be randomized in this study:
• Adult male or female patient, aged between 18 to 60 years (both inclusive).
• Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
• Patient has mild conditions meeting all of the following criteria:
• Oxygen saturation ≥ 94% on room air.
• Not requiring supplemental oxygen.
• Onset of symptom is no more than 7 days prior to the study drug administration.

You may not qualify if:

• \. Patient with severe condition meeting one of the following:
• Respiratory distress with respiratory rate ≥ 30 breaths/min.
• Requires supplemental oxygen.
• Experience shock.
• Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
• Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Incheon Medical Center

Incheon, South Korea

Location

Related Publications (3)

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

  PMID: 35713300 DERIVED

• Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.

  PMID: 34551869 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

regdanvimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: JiWoong Lim
• Organization: Celltrion Inc.

jiwoong.lim@celltrion.com

82-32-850-5806

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 20, 2020
• Study Start: September 4, 2020
• Primary Completion: October 26, 2020
• Study Completion: April 5, 2021
• Last Updated: April 8, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-04

Locations

KR (1)