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 SARS-CoV-2 Infection
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 1,642
研究概览
简要总结
Study CT-P59 3.2 results demonstrated that CT-P59 was efficacious in treatment mild to moderate SARS-CoV-2 infection, compared to the placebo. In Part 1, CT-P59 significantly reduced the proportion of patients with clinical symptoms requiring hospitalization or oxygen therapy due to SARS-CoV-2 infection up to Day 28, compared to the Placebo group (CT-P59 group: 4.4% vs. Placebo group: 8.7%). This demonstrates that CT-P59 would effectively reduce the clinical symptoms of patients and burden of the healthcare system due to SARS-CoV-2 infection. Also, CT-P59 effectively reduced the time to negative conversion by RT-qPCR and time to clinical recovery up to Day 14, compared to the placebo. The median [95% CI] time to negative conversion by RT-qPCR up to Day 14 was 12.75 [9.00, 12.84), 11.89 [8.94, 12.91), 12.94 [12.75, 13.99), and the median [95% CI] time to clinical recovery up to Day 14 was 7.18 [5.50, 9.37), 7.30 [5.72, 9.33), 8.80 [6.88, 13.09) in CT-P59 40 mg/kg, CT-P59 80 mg/kg, and Placebo groups, respectively. The mean CT-P59 serum concentration throughout the study was higher in the CT-P59 80 mg/kg group compared to CT-P59 40 mg/kg group and showed dose proportionality at all time points. Based on the Part 1 results, CT-P59 40 mg/kg was selected as the appropriate dose for CT-P59 treatment. In Part 2, results of CT-P59 were statistically significant by reducing the proportion of patients with clinical symptoms requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28, compared to the Placebo group in both high-risk and all randomized patients ([high-risk patients] CT-P59 40 mg/kg group 3.1% and Placebo group 11.1%, p<0.0001; [all randomized patients] 2.4% and 8.0%, p<0.0001, respectively). Also, the median time to clinical recovery [95% CI) up to Day 14 reduced in the CT-P59 40 mg/kg group of high-risk and all randomized patients, compared to the Placebo group ([high-risk patients] CT-P59 40 mg/kg group: 9.27 [8.27, 11.05) and Placebo group: not calculated [12.35, not calculated) days; [all randomized patients] 8.38 [7.91, 9.33) and 13.25 [11.94, not calculated) days, respectively), and the differences in time to clinical recovery between the groups were statistically significant (p<0.0001). Reduced proportion of patients with clinical symptoms and time to clinical recovery demonstrate that CT-P59 would effectively reduce burden of the healthcare system due to SARS-CoV-2 infection by preventing the progression of disease severity. Collectively, CT-P59 40 mg/kg met its primary and all key secondary endpoints, with other secondary endpoints trended in favor of CT-P59, providing a strong indication of efficacy. Overall, in Part 1 and Part 2, CT-P59 was well tolerated and safety profile following CT-P59 administration did not show any significant safety issues. Also, greater reductions from baseline viral load were shown in CT-P59 compared to placebo.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR.
- •Oxygen saturation >94% on room air, and not requiring supplemental oxygen.
- •Patient whose onset of symptom is no more than 7 days prior to the study drug administration.
- •Patient had 1 or more of the SARS-CoV-2 infection-associated symptoms within but no more than 7 days prior to the study drug administration.
排除标准
- •Patient had current severe condition meeting one of the following:
- •a. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions (severe disease as defined in the World Health Organization Guidance, 2020).
- •b. Respiratory distress with respiratory rate =30 breaths/min.
- •c. Required supplemental oxygen.
- •d. Experienced shock.
- •e. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion.
- •Patient had received or had a plan to receive any of following prohibited medications or treatments:
- •a. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration.
- •b. Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration.
- •c. 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.
- •d. Use of medications that are contraindicated with SoC.
- •e. SARS-CoV-2 vaccine prior to the study drug administration