A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients with Mild to Moderate SARS-CoV-2 Infectio
- Conditions
- Codes for special purposes
- Registration Number
- KCT0005641
- Lead Sponsor
- Celltrion
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1642
• 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.
• 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection (Part 1);Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR at each visit (Part 1);Time to negative conversion in nasopharyngeal swab specimen (Part 1);Time to clinical recovery (Part 1);Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection in high-risk patients (Part 2)
- Secondary Outcome Measures
Name Time Method Time to clinical recovery in high-risk patients (Part 2);Time to clinical recovery in all randomized patients (Part 2);Proportion of patients with hospital admission due to SARS-CoV-2 Infection (Part 1 and Part 2);Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 Infection (Part 1 and Part 2);Proportion of Patients with Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2);Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2);Proportion of Patients with Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2);Proportion of Patients with All-cause mortality Due to SARS-CoV-2 Infection (Part 1 and Part 2);Adverse events (AEs; including serious adverse events [SAEs]);Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 Infection in all randomized patients (Part 2)