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
About this trial
This is an interventional treatment trial for 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:
1. 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.
Sites / Locations
- Incheon Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort 1 will receive a dose of CT-P59 or matching placebo
Cohort 2 will receive a dose of CT-P59 or matching placebo
Cohort 3 will receive a dose of CT-P59 or matching placebo
Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59