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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2021-04-05

Brief Summary

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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.

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Detailed Description

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'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.

Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 will receive a dose of CT-P59 or matching placebo

Drug: CT-P59

CT-P59 will be administered

Drug: Placebo

Placebo-matching CT-P59

Group Type EXPERIMENTAL

CT-P59

Intervention Type BIOLOGICAL

administered

Cohort 2 will receive a dose of CT-P59 or matching placebo

Drug: CT-P59

CT-P59 will be administered

Drug: Placebo

Placebo-matching CT-P59

Group Type EXPERIMENTAL

CT-P59

Intervention Type BIOLOGICAL

administered

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

Group Type EXPERIMENTAL

CT-P59

Intervention Type BIOLOGICAL

administered

Interventions

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CT-P59

administered

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No