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

Celltrion Healthcare

Status and phase: Completed; Phase 3; Phase 2

Conditions: SARS-CoV-2 Infection

Treatments: Biological: CT-P59; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04602000

2020-003369-20 (EudraCT Number)

CT-P59 3.2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,642 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,642 participants in 5 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Biological: CT-P59

Biological: CT-P59

Biological: CT-P59

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

Experimental group

Description:

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

Treatment:

Biological: CT-P59

Biological: CT-P59

Biological: CT-P59

Placebo group (Part 1)

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

Biological: Placebo

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

Experimental group

Description:

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

Treatment:

Biological: CT-P59

Biological: CT-P59

Biological: CT-P59

Placebo group (Part 2)

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

Biological: Placebo