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)

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: SARS-CoV-2 Infection

Treatments: Biological: CT-P59

Study type: Interventional

Funder types: Industry

Identifiers

NCT04593641

2020-003165-19 (EudraCT Number)

CT-P59 1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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:

2. Respiratory distress with respiratory rate ≥ 30 breaths/min.

3. Requires supplemental oxygen.

4. Experience shock.

5. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.

6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups

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

Experimental group

Description:

Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Treatment:

Biological: CT-P59

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

Experimental group

Description:

Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Treatment:

Biological: CT-P59

Cohort 3 will receive a dose of CT-P59 or matching placebo

Experimental group

Description:

Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Treatment:

Biological: CT-P59