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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1642 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-10-20

Brief Summary

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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.

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Detailed Description

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CT-P59 is a human monoclonal antibody targeted against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein as a treatment for SARS-CoV-2 infection, which is manufactured by recombinant deoxyribonucleic acid technology in a Chinese hamster ovary mammalian cell line. This Phase 2/3, randomized, parallel-group, placebo-controlled, double-blind study was designed to evaluate the safety, tolerability, and therapeutic potential of CT-P59 in outpatients with mild to moderate SARS-CoV-2 infection, not requiring supplemental oxygen therapy.

Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

CT-P59

Intervention Type BIOLOGICAL

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

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

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

Group Type EXPERIMENTAL

CT-P59

Intervention Type BIOLOGICAL

CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

Placebo group (Part 1)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

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

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

Group Type EXPERIMENTAL

CT-P59

Intervention Type BIOLOGICAL

CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

Placebo group (Part 2)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

Interventions

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CT-P59

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

Intervention Type BIOLOGICAL

CT-P59

CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

CT-P59

CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

Intervention Type BIOLOGICAL

Placebo

Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)

Intervention Type BIOLOGICAL

Other Intervention Names

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regdanvimab regdanvimab regdanvimab

Eligibility Criteria

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Inclusion Criteria

Patient had to meet all of the following criteria to be randomized in this study.

1. Patient was an adult male or female patient, aged 18 or above.
2. 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).
3. Patient with conditions meeting all of the following criteria:

1. Oxygen saturation \> 94% on room air.
2. Not requiring supplemental oxygen.
4. Patient who had an onset of symptom no more than 7 days prior to the study drug administration.
5. 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.

Exclusion Criteria

Patients meeting any of the following criteria were excluded from the study.

1. Patient had current severe condition meeting one of the following:

1. Previous or current hospitalization or requirement of hospitalization for treatment of serious SARS-CoV-2 related conditions.
2. Respiratory distress with respiratory rate ≥30 breaths/min.
3. Required supplemental oxygen
4. Experienced shock
5. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
2. Patient had received or had a plan to receive any of the 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, 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
2. Any SARS-CoV-2 human IV 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No