Trial · NCT04602000
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
NCT04602000, Phase 2, Phase 3, Completed, Celltrion; results first posted 2022-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection. Trials, record NCT04602000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04602000
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
- NCT number
- NCT04602000
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,642 participants, actual
- Lead sponsor
- Celltrion
- Conditions
- SARS-CoV-2 Infection
- Interventions
- CT-P59, CT-P59, Placebo, CT-P59, Placebo
- First posted
- 2020-10-26
- Last updated
- 2022-07-20
- Other registries' IDs
- eudract:2020-003369-20
- Results first posted
- 2022-07-20
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | Up to Day 28 | To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 |
| Primary | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Up to Day 14 | To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of negative conversion in nasopharyngeal swab specimen based on RT-qPCR up to Day 14 |
| Primary | Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | Up to Day 14 | To evaluate the therapeutic efficacy of CT-P59 as determined by time to negative conversion by RT-qPCR up to Day 14 |
| Primary | Time to Clinical Recovery (Part 1) | Up to Day 14 | To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. |
| Primary | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2) | Up to Day 28 | To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in high-risk patients |
| Secondary | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2) | Up to Day 28 | To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 in all randomized patients |
| Secondary | Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) | Up to Day 14 | To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in high-risk patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. |
| Secondary | Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) | Up to Day 14 | To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 in all randomized patients. Clinical recovery was defined as all symptoms on the SARS-CoV-2 Infection Symptom Checklist 1 being recorded as 'absent' or 'mild' in intensity for at least 48 hours. SARS-CoV-2 Infection Symptom Checklist 1 consisted of 7 symptoms (feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle pain, fatigue, and headache) and the intensity of patient's self-aware for each SARS-CoV-2 infection symptom (absent \[0\], mild \[1\]. moderate \[2\], and severe \[3\]). To meet the clinical recovery, symptoms 'severe' or 'moderate' in intensity at baseline should be changed to 'mild' or 'absent', or symptoms 'mild' in intensity at baseline should be changed to 'absent', after the study drug administration. Symptoms "absent" in intensity at baseline should maintain as "absent" for at least 48 hours. |
| Secondary | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | To evaluate the additional efficacy of CT-P59 |
| Secondary | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | To evaluate the additional efficacy of CT-P59 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | Up to Day 28 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Up to Day 14 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | Up to Day 14 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) | days | MEDIAN |
| PRIMARY | Time to Clinical Recovery (Part 1) | Up to Day 14 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included; Patients who have absent for all symptoms or at least one missing at baseline are excluded.) | days | MEDIAN |
| PRIMARY | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2) | Up to Day 28 | ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2) | Up to Day 28 | ITT Set (defined as all randomly assigned patients to the study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) | Up to Day 14 | ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria; Patient who reported at least 1 symptom at baseline was included) | days | MEDIAN |
| SECONDARY | Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) | Up to Day 14 | ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included) | days | MEDIAN |
| SECONDARY | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | CT-P59 40 mg/kg Group (Part 1) | 4 | Participants | ||
| Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | CT-P59 80 mg/kg Group (Part 1) | 5 | Participants | ||
| Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | Placebo Group (Part 1) | 9 | Participants | ||
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | CT-P59 40 mg/kg Group (Part 1) | Day 2 | 0 | Participants | |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | CT-P59 80 mg/kg Group (Part 1) | Day 2 | 1 | Participants | |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Placebo Group (Part 1) | Day 2 | 0 | Participants | |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | CT-P59 40 mg/kg Group (Part 1) | Day 3 | 4 | Participants | |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | CT-P59 80 mg/kg Group (Part 1) | Day 3 | 4 | Participants | |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Placebo Group (Part 1) | Day 3 | 3 | Participants | |
| Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | CT-P59 40 mg/kg Group (Part 1) | Day 4 | 2 | Participants |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CT-P59 40 mg/kg Group (Part 1) | 105 | |
| Overall Study | STARTED | CT-P59 80 mg/kg Group (Part 1) | 111 | |
| Overall Study | STARTED | Placebo Group (Part 1) | 111 | |
| Overall Study | STARTED | CT-P59 40 mg/kg Group (Part 2) | 656 | |
| Overall Study | STARTED | Placebo Group (Part 2) | 659 | |
| Overall Study | COMPLETED | CT-P59 40 mg/kg Group (Part 1) | 97 | |
| Overall Study | COMPLETED | CT-P59 80 mg/kg Group (Part 1) | 103 | |
| Overall Study | COMPLETED | Placebo Group (Part 1) | 105 | |
| Overall Study | COMPLETED | CT-P59 40 mg/kg Group (Part 2) | 618 | |
| Overall Study | COMPLETED | Placebo Group (Part 2) | 608 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | CT-P59 40 mg/kg Group (Part 1) | 3 | 105 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | CT-P59 80 mg/kg Group (Part 1) | 3 | 110 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Group (Part 1) | 0 | 110 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | CT-P59 40 mg/kg Group (Part 2) | 6 | 652 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Group (Part 2) | 12 | 650 | 12 |
| other | Thrombocytosis | Blood and lymphatic system disorders | CT-P59 40 mg/kg Group (Part 1) | 3 | 105 | 3 |
| other | Thrombocytosis | Blood and lymphatic system disorders | CT-P59 80 mg/kg Group (Part 1) | 1 | 110 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo Group (Part 1) | 2 | 110 | 2 |
| other | Thrombocytosis | Blood and lymphatic system disorders | CT-P59 40 mg/kg Group (Part 2) | 11 | 652 | 11 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo Group (Part 2) | 5 | 650 | 5 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT-P59 40 mg/kg Group (Part 1) | 0 | 105 |
| Total, all-cause mortality | CT-P59 80 mg/kg Group (Part 1) | 0 | 110 |
| Total, all-cause mortality | Placebo Group (Part 1) | 0 | 110 |
| Total, all-cause mortality | CT-P59 40 mg/kg Group (Part 2) | 1 | 652 |
| Total, all-cause mortality | Placebo Group (Part 2) | 2 | 650 |
| Total, other adverse events | CT-P59 40 mg/kg Group (Part 1) | 19 | 105 |
| Total, other adverse events | CT-P59 80 mg/kg Group (Part 1) | 18 | 110 |
| Total, other adverse events | Placebo Group (Part 1) | 17 | 110 |
| Total, other adverse events | CT-P59 40 mg/kg Group (Part 2) | 119 | 652 |
| Total, other adverse events | Placebo Group (Part 2) | 128 | 650 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
CT-P59 40 mg/kg Group (Part 2) vs Placebo Group (Part 2): Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2) | Trial comparisons |
CT-P59 40 mg/kg Group (Part 2) vs Placebo Group (Part 2): Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04602000
GET https://conductscience.org/api/trials/v1/NCT04602000/registered?page=2