To Evaluate the Safety and Efficacy of CT-P59 in Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04602000 |
Recruitment Status :
Completed
First Posted : October 26, 2020
Last Update Posted : November 30, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 Infection | Biological: CT-P59/Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1642 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection |
Actual Study Start Date : | September 25, 2020 |
Actual Primary Completion Date : | May 21, 2021 |
Actual Study Completion Date : | October 20, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: CT-P59 Arm 1 & CT-P59 Arm 2 |
Biological: CT-P59/Placebo
administered |
Placebo Comparator: Placebo |
Biological: CT-P59/Placebo
administered |
- Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]To evaluate the therapeutic efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection.
- Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]To evaluate the therapeutic efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection.
- Time to clinical recovery for Part 1 (Phase II) [ Time Frame: Up to Day 14 ]To evaluate the therapeutic efficacy of CT-P59 as of clinical recovery of the patients' SARS-CoV-2 symptoms.
- Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 1 (Phase II) [ Time Frame: Up to Day 28 ]To evaluate the therapeutic efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection in high-risk patients for Part 2 (Phase III) [ Time Frame: Up to Day 28 ]To evaluate the therapeutic efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Proportion of patients with all-cause mortality for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Time to clinical recovery for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of clinical recovery of the patients' SARS-CoV-2 symptoms
- Duration of fever for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of the duration of fever of the patients
- Proportion of patients with hospital admission due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Proportion of mechanical ventilation due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of clinical events related to SARS-CoV-2 infection
- Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection.
- Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection
- Proportion of patients requiring rescue therapy due to SARS-CoV-2 infection for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection
- Time to national early warning score 2 (NEWS2) of 0 for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection
- Scores of other known SARS-CoV-2 infection symptoms such as vomiting, diarrhea, loss of taste or smell for Part 1 and Part 2 [ Time Frame: Up to Day 14 and 28 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection
- Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection for Part 2 [ Time Frame: Up to Day 28 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection
- Time to clinical recovery in high-risk patients for Part 2 [ Time Frame: Up to Day 14 ]To evaluate the overall efficacy of CT-P59 as of negative conversion of SARS-CoV-2 infection

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet all of the following criteria to be randomized in this study:
- Adult male or female patient, aged 18 or above.
- Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic testor RT-PCR.
-
Patient has mild conditions meeting all of the following criteria:
- Oxygen saturation ≥ 94% on room air.
- Not requiring supplemental oxygen.
- Patient who has one or more of the SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration
Exclusion Criteria:
-
Patient with severe condition meeting one of the following:
- Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions.
- 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.
-
Patient who has received or has a plan to receive any of following prohibited medications or treatments:
- Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine(unless used chronically for autoimmune diseases), dexamethasone, and other immunomodulatory agents and human immunodeficiency virusprotease inhibitorsfor therapeutic purpose of SARS-CoV-2 infection prior to study drug administration
- Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration
- Any other investigational device or medical product including but not limited to any monoclonal antibody(tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration.
- Use of medications that are contraindicated with SoC.
- SARS-CoV-2 vaccine prior to the study drug administration

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602000
Korea, Republic of | |
Chungnam National University Hospital | |
Daejeon, Jung-gu, Korea, Republic of, 35015 |
Responsible Party: | Celltrion |
ClinicalTrials.gov Identifier: | NCT04602000 |
Other Study ID Numbers: |
CT-P59 3.2 |
First Posted: | October 26, 2020 Key Record Dates |
Last Update Posted: | November 30, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Infections COVID-19 Severe Acute Respiratory Syndrome Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |