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.
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.
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Name: regdanvimab
Biological: CT-P59
CT-P59 (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Other Name: regdanvimab
Biological: Placebo
Placebo (80 mg/kg) by IV infusion administered over 90 minutes, once (Part 1)
Biological: CT-P59
CT-P59 (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
Other Name: regdanvimab
Biological: Placebo
Placebo (40 mg/kg) by IV infusion administered over 60 minutes, once (Part 2)
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
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of