An Open Label, Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR)
研究概览
简要总结
To evaluate the efficacy of subcutaneous ropeginterferon alfa 2b ( P1101 combined with standard of care (SOC) compared with standard care alone in adult COVID-19 patients with comorbidities.
详细描述
This is a multi-center, open label, control study to evaluate the efficacy and safety of ropeginterferon alfa-2b in the treatment of adult COVID-19 patients with comorbidities. Adult COVID-19 patient with the specific comorbidities and being non-responder to the other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and molnupiravir, or the patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has positive result (Ct <30) 14 days after the symptom onset of COVID-19 will be enrolled. The eligible patients will be randomized to receive the ropeginterferon alfa-2b plus SOC (study group) or to receive SOC alone (control group). For study group, a single dose of 250 μg ropeginterferon alfa-2b will be subcutaneous administrated at Day 1 visit. For patients who still have positive result (Ct <30) in SARS-CoV-2 RT-PCR at Day 15 and Day 29, the second dose of ropeginterferon alfa-2b at 350 μg and the third dose at 500 μg will be administered, respectively. For control group, patients will receive the SOC alone. The efficacy and safety of ropeginterferon alfa-2b will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to provide a written ICF before entering the study;
- •Male or non-pregnant female patients, ≥ 18 years of age at the time of enrolment (or other age required by local regulations);
- •Patient with the diagnosis of COVID-19 and with the Ct value <30 in SARS-CoV-2 RT-PCR;
- •Patients with any comorbidity below at screening:
- •Hematologic cancer;
- •Solid tumor that requires chemotherapy or other systemic therapy;
- •Well controlled autoimmune diseases; or any other medical comorbidities that requires immunosuppressive therapy;
- •Non-responder to the treatment of any other anti-SARS-CoV-2 drugs, i.e., remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir; or patients who is not suitable to receive the other anti-SARS-CoV-2 drugs by investigator's judgement and has Ct <30 14 days after the symptom onset of COVID-
- •Non-responder is defined as a patient who received remdesivir, nirmatrelvir/ritonavir, and/or molnupiravir but still has Ct <30 14 days after the symptom onset of COVID-
- •Agrees to the collection of nasopharyngeal or pharyngeal swabs and blood sample as per protocol.
排除标准
- •Known history or presence of decompensated cirrhosis of the liver (Child-Pugh B or C) before study entry;
- •Chronic kidney disease with eGFR <15 mL/min/1.73 m2;
- •Females who are breast-feeding, lactating, pregnant or intending to become pregnant;
- •Known history of severe allergic or hypersensitivity reactions to the active substance or to any of the excipients of ropeginterferon alfa-2b;
- •Known history or presence of poorly controlled or clinically significant medical conditions that are not suitable to be enrolled, at the discretion of the investigator, e.g., major psychiatric (including but not limited to those with severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt) or poorly controlled autoimmune diseases;
- •Clinically significant medical conditions known to interfere with absorption, distribution, metabolism or excretion of the study drugs;
- •Patients treated by monotherapy of telbivudine or any other combination therapy with telbivudine within 1 month prior to screening;
- •Use of an investigational medical product within 1 month prior to screening.
研究组 & 干预措施
Study Group
Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)
干预措施: Ropeginterferon alfa-2b (Drug)
Study Group
Treated with P1101 (Ropeginterferon alfa-2b) plus standard of care (SOC)
干预措施: SOC (Procedure)
Control Group
Treated with SOC alone
干预措施: SOC (Procedure)
结局指标
主要结局
Time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative reverse transcriptase polymerase chain reaction (RT-PCR)
时间窗: Up to Day 57
To compare the time from randomization to the achievement of Ct value ≥30 in SARS-CoV-2 quantitative RT-PCR between the Study and Control groups
次要结局
- Change from randomization in the clinical status(Up to Day 43)
- The occurrence and the accumulated duration (days) of supple-mental oxygen(Up to Day 57)
- Change of SpO2(Up to Day 43)
- The occurrence and the accumulated duration (days) of mechanical ventilation(Up to Day 57)
- The proportion of patients who achieve Ct value ≥30 in quantitative SARS-CoV-2 RT-PCR at Day 15, Day 29, and Day 43(Up to Day 43)