Phase 3
N=1,642
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
SARS-CoV-2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT04602000 ↗Enrolled (actual)
1,642
Serious AEs
0.7%
Results posted
Jul 2022
Primary outcome: Primary: Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) — 4; 5; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P59 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celltrion
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) |
4; 5; 9 | — |
| PRIMARY Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) |
0; 1; 0; 4; 4; 3 | — |
| PRIMARY Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) |
12.75; 11.89; 12.94 | — |
| PRIMARY Time to Clinical Recovery (Part 1) |
7.18; 7.30; 8.80 | — |
| PRIMARY 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) |
14; 48 | <0.0001 sig |
| SECONDARY 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) |
16; 53 | — |
| SECONDARY Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) |
9.27; NA | — |
| SECONDARY Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) |
8.38; 13.25 | — |
| SECONDARY Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) |
4; 5; 9; 16; 52 | — |
| SECONDARY Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) |
4; 4; 9; 15; 49 | — |
| SECONDARY Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) |
0; 1; 0; 0; 3 | — |
| SECONDARY Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) |
7; 11; 15; 37; 85 | — |
| SECONDARY Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) |
0; 0; 0; 0; 5 | — |
| SECONDARY Proportion of Patients With All-cause Mortality (Part 1 and Part 2) |
0; 0; 0; 1; 2 | — |
| SECONDARY Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) |
12.75; 11.89; 12.94; 11.90; 13.15 | — |
| SECONDARY Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) |
4; 4; 3; 34; 21; 8 | — |
| SECONDARY Time to Clinical Recovery (Part 1 and Part 2) |
7.18; 7.30; 8.80; 8.39; 13.29 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT04602000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.