Clinical trial NCT04593641: 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)
Official title: A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SARS-CoV-2 Infection
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.

Eligibility criteria: Inclusion Criteria:

Each patient must meet all of the following criteria to be randomized in this study:

1. Adult male or female patient, aged between 18 to 60 years (both inclusive).
2. Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
3. Patient has mild conditions meeting all of the following criteria:

   1. Oxygen saturation ≥ 94% on room air.
   2. Not requiring supplemental oxygen.
4. Onset of symptom is no more than 7 days prior to the study drug administration.

Exclusion Criteria:

1. Patient with severe condition meeting one of the following:

1. Respiratory distress with respiratory rate ≥ 30 breaths/min.
2. Requires supplemental oxygen.
3. Experience shock.
4. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
5. 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.

Primary outcomes:
measure: Number of Patients With TEAEs
timeFrame: Up to Day 14
measure: Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Day 14
measure: Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)
timeFrame: Up to Day 14
measure: Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
timeFrame: Up to Day 14
Secondary outcomes:
measure: The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
timeFrame: At Day 28
measure: Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
timeFrame: Up to Day 28
measure: Area Under the Concentration-time Curve of Viral Titers for qPCR
timeFrame: Up to Day 28
measure: Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
timeFrame: Up to Day 28
measure: Number of Patients With Clinical Recovery
timeFrame: Up to Day 28
measure: Number of Patients Requiring Supplemental Oxygen
timeFrame: Up to Day 28
measure: Number of Patients With Intensive Care Unit Transfer
timeFrame: Up to Day 28
measure: Number of Mechanical Ventilation
timeFrame: Up to Day 28
measure: Number of Patients With All-cause Mortality
timeFrame: Up to Day 28
measure: Number of Patients With Hospital Admission
timeFrame: Up to Day 28
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59
timeFrame: Up to Day 90
measure: Time to Cmax (Tmax) of CT-P59
timeFrame: Up to Day 90
measure: Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)
timeFrame: Up to Day 90
measure: Terminal Half-life (t1/2) of CT-P59
timeFrame: Up to Day 90
measure: Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59
timeFrame: Up to Day 90
measure: Terminal Elimination Rate Constant (λz) of CT-P59
timeFrame: Up to Day 90
measure: Total Body Clearance (CL) of CT-P59
timeFrame: Up to Day 90
measure: Volume of Distribution During the Elimination Phase (Vz) of CT-P59
timeFrame: Up to Day 90
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon Medical Center
Study officials:
References:
citation: Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
citation: Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.