A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection

NCT04602000 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CT-P59 3.22020-003369-20
• Study Type: interventional
• Target: 1,642
• Locations: 1 country
• Sites: 1

Brief Summary

This was 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 the safety during after study drug injection.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (5)

• Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)

  To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28

  Up to Day 28

• Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1)

  To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14

  Up to Day 14

• Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1)

  To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14

  Up to Day 14

• Time to Clinical Recovery (Part 1)

  To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours.

  Up to Day 14

• Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2)

  To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in high-risk patients

  Up to Day 28

Secondary Outcomes (12)

• Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2)

  Up to Day 28

• Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2)

  Up to Day 14

• Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2)

  Up to Day 14

• Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2)

  Up to Day 28

• Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2)

  Up to Day 28

Other Outcomes (4)

• [Virology] Viral Serology for SARS-CoV-2 Antibody

  Days 1, 7, 14, 28, and 56

• [PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1)

  Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion

• [PK] Maximum Serum Concentration (Cmax) (Part 1)

  Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion

Study Arms (5)

CT-P59 40 mg/kg group (Part 1)

EXPERIMENTAL

CT-P59 (regdanvimab), 40 mg/kg by IV infusion once

Biological: CT-P59

CT-P59 80 mg/kg group (Part 1)

EXPERIMENTAL

CT-P59 (regdanvimab), 80 mg/kg by IV infusion once

Biological: CT-P59

Placebo group (Part 1)

PLACEBO COMPARATOR

Placebo, matching in volume of CT-P59 80 mg/kg by IV infusion once

Biological: Placebo

CT-P59 40 mg/kg group (Part 2)

EXPERIMENTAL

CT-P59 (regdanvimab), 40 mg/kg by IV infusion once

Biological: CT-P59

Placebo group (Part 2)

PLACEBO COMPARATOR

Placebo, matching in volume of CT-P59 40 mg/kg by IV infusion once

Biological: Placebo

Interventions

CT-P59 BIOLOGICAL

CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

Also known as: regdanvimab

CT-P59 40 mg/kg group (Part 1)

Placebo BIOLOGICAL

Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

Placebo group (Part 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had to meet all of the following criteria to be randomized in this study.
• Patient was an adult male or female patient, aged 18 or above.
• Patient was diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR (reverse transcription-polymerase chain reaction).
• Patient with conditions meeting all of the following criteria:
• Oxygen saturation \> 94% on room air.
• Not requiring supplemental oxygen.
• Patient who had an onset of symptom no more than 7 days prior to the study drug administration.
• Patient had 1 or more of the SARS-CoV-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration.

You may not qualify if:

• Patients meeting any of the following criteria were excluded from the study.
• Patient had current severe condition meeting one of the following:
• Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions.
• Respiratory distress with respiratory rate ≥30 breaths/min.
• Required supplemental oxygen
• Experienced shock
• Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
• Patient had received or had a plan to receive any of the 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 remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
• Any SARS-CoV-2 human IV immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration
• 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
• Use of medications that are contraindicated with SoC
• SARS-CoV-2 vaccine prior to the study drug administration

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

Location

Related Publications (4)

• Kim JY, Sandulescu O, Preotescu LL, Rivera-Martinez NE, Dobryanska M, Birlutiu V, Miftode EG, Gaibu N, Caliman-Sturdza O, Florescu SA, Shi HJ, Streinu-Cercel A, Streinu-Cercel A, Lee SJ, Kim SH, Chang I, Bae YJ, Suh JH, Chung DR, Kim SJ, Kim MR, Lee SG, Park G, Eom JS. A Randomized Clinical Trial of Regdanvimab in High-Risk Patients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Aug 8;9(8):ofac406. doi: 10.1093/ofid/ofac406. eCollection 2022 Aug.

  PMID: 36043180 DERIVED

• 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

• Streinu-Cercel A, Sandulescu O, Preotescu LL, Kim JY, Kim YS, Cheon S, Jang YR, Lee SJ, Kim SH, Chang I, Suh JH, Lee SG, Kim MR, Chung DR, Kim HN, Streinu-Cercel A, Eom JS. Efficacy and Safety of Regdanvimab (CT-P59): A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial in Outpatients With Mild-to-Moderate Coronavirus Disease 2019. Open Forum Infect Dis. 2022 Feb 2;9(4):ofac053. doi: 10.1093/ofid/ofac053. eCollection 2022 Apr.

  PMID: 35295819 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: Yun Ju Bae / Head of Clinical Planning 1 Department
• Organization: Celltrion, Inc

YunJu.Bae@celltrion.com

+82 32 850 4160

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 26, 2020
• Study Start: October 5, 2020
• Primary Completion: May 21, 2021
• Study Completion: October 20, 2021
• Last Updated: July 20, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)