Comparison · NCT04602000-25c45114
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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT04602000-25c45114. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04602000-25c45114
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0314 | 0.0188 | 0.052 | wilson | |
| Risk in group 2 | 0.111 | 0.0844 | 0.144 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0792 | -0.115 | -0.0459 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.284 | 0.159 | 0.507 | log | |
| Odds ratio, group 1 over group 2 | 0.261 | 0.141 | 0.48 | log | |
| Number needed to treat, for one fewer participant with the outcome on CT-P59 40 mg/kg Group (Part 2) than on Placebo Group (Part 2) | 12.6 | 8.73 | 21.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CT-P59 40 mg/kg Group (Part 2) | Each participant received CT-P59 (regdanvimab) 40 mg/kg by IV infusion on Day 1. | 14 | 446 | OG000 |
| Group 2 | Placebo Group (Part 2) | Each participant received placebo, matching in volume of CT-P59 40 mg/kg, by IV infusion on Day 1. | 48 | 434 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- 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)
- Description
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
- Time frame
- Up to Day 28
- Population
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)
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE2, PHASE3
- Conditions
- SARS-CoV-2 Infection
- Interventions
- CT-P59, CT-P59, Placebo, CT-P59, Placebo
- Lead sponsor
- Celltrion
- Results first posted
- 2022-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04602000?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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