Phase 1
N=18
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
SARS-CoV-2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT04593641 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Patients With TEAEs — 3; 4; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CT-P59 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celltrion
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With TEAEs |
3; 4; 3; 1 | — |
| PRIMARY Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) |
0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) |
0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) |
0; 0; 0; 0 | — |
| SECONDARY The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) |
4; 4; 2; 2; 1; 1 | — |
| SECONDARY Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR |
17.49; 12.50; 18.51; 14.19 | — |
| SECONDARY Area Under the Concentration-time Curve of Viral Titers for qPCR |
55.45; 41.05; 56.26; 60.26 | — |
| SECONDARY Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR |
0.382; 0.452; 1.008; 0.637; -6.326; -4.258 | — |
| SECONDARY Number of Patients With Clinical Recovery |
5; 5; 5; 2 | — |
| SECONDARY Number of Patients Requiring Supplemental Oxygen |
3; 0; 0; 1 | — |
| SECONDARY Number of Patients With Intensive Care Unit Transfer |
0; 0; 0; 0 | — |
| SECONDARY Number of Mechanical Ventilation |
0; 0; 0; 0 | — |
| SECONDARY Number of Patients With All-cause Mortality |
0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Hospital Admission |
0; 0; 0; 1 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59 |
84538893.8; 178065255.1; 433826801.0 | — |
| SECONDARY Time to Cmax (Tmax) of CT-P59 |
2.500; 2.500; 2.500 | — |
| SECONDARY Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose) |
62595.7; 58838.6; 60936.0 | — |
| SECONDARY Terminal Half-life (t1/2) of CT-P59 |
357.1; 380.8; 496.3 | — |
| SECONDARY Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59 |
5.917; 1.242; 3.953 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) of CT-P59 |
0.00196; 0.001827; 0.001493 | — |
| SECONDARY Total Body Clearance (CL) of CT-P59 |
16.18; 17.46; 16.86 | — |
| SECONDARY Volume of Distribution During the Elimination Phase (Vz) of CT-P59 |
8351.9; 9514.7; 11968.2 | — |
Summary
This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.
Eligibility Criteria
Inclusion Criteria
Each patient must meet all of the following criteria to be randomized in this study:
- Adult male or female patient, aged between 18 to 60 years (both inclusive).
- Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
- Patient has mild conditions meeting all of the following criteria:
- Oxygen saturation ≥ 94% on room air.
- Not requiring supplemental oxygen.
- Onset of symptom is no more than 7 days prior to the study drug administration.
Exclusion Criteria
- Patient with severe condition meeting one of the following:
- Respiratory distress with respiratory rate ≥ 30 breaths/min.
- Requires supplemental oxygen.
- Experience shock.
- Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
- Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.
Data sourced from ClinicalTrials.gov (NCT04593641). 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.