Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital, No. 7, Chung-Shan South Road, Taipei, 10002, Taiwan.
Department of Medicine, National Taiwan University Cancer Center, Taipei, Taiwan.
Adv Ther. 2024 Feb;41(2):847-856. doi: 10.1007/s12325-023-02715-7. Epub 2023 Nov 27.
Ropeginterferon alfa-2b represents a new-generation PEGylated interferon. It is approved for the treatment of polycythemia vera and shows promising anti-SARS-CoV-2 activities.
This clinical study aims to evaluate the efficacy and safety of ropeginterferon alfa-2b in patients with coronavirus disease 2019 (COVID-19) and comorbidities.
The randomized controlled study is designed to enroll adult patients with COVID-19 infection and comorbidities. Patients are non-responders to anti-SARS-CoV-2 drugs or not suitable to receive them. Comorbidities include hematologic cancer, solid tumor, and well-controlled autoimmune disease. Non-responders to anti-SARS-CoV-2 drugs are defined as having received treatment but have a Ct value < 30 at 14 days after symptom onset. Patients are randomized in a 1:1 ratio to receive ropeginterferon alfa-2b at 250 μg plus standard of care (SOC) or SOC alone. SARS-CoV-2 antigen test will be conducted at day 15 and day 29 visits to determine whether to administer additional ropeginterferon alfa-2b doses. Patients who are positive on the antigen test on days 15 and 29 will receive the second and third doses of ropeginterferon alfa-2b at 350 μg and 500 μg, respectively. Patients with a negative antigen test but a Ct value < 30 by reverse transcription polymerase chain reaction (RT-PCR) at days 15 and 29 are also administered the second (350 μg) and third (500 μg) doses. Patients at high risk of COVID-19 rebound/relapse, e.g., immunocompromised patients, will be given additional ropeginterferon alfa-2b doses even if the Ct is ≥ 30. Approximately 60 patients will be enrolled.
The primary outcome is to compare the time from randomization to the achievement of Ct value ≥ 30 by RT-PCR between ropeginterferon alfa-2b and control groups. Our previous studies have shown safety and promising anti-SARS-CoV-2 activities in patients with moderate or severe COVID-19. This study will provide valuable data in patients with COVID-19 and comorbidities, for whom safe and effective treatment is urgently needed.
This trial is registered at ClinicalTrials.gov (Identifier NCT05808322).
罗匹尼罗干扰素 alfa-2b 是一种新型聚乙二醇化干扰素。它被批准用于治疗真性红细胞增多症，并显示出有希望的抗 SARS-CoV-2 活性。
本临床研究旨在评估罗匹尼罗干扰素 alfa-2b 在患有 2019 年冠状病毒病 (COVID-19) 和合并症的患者中的疗效和安全性。
这项随机对照研究旨在招募感染 COVID-19 且合并症的成年患者。患者对 SARS-CoV-2 药物无反应或不适合使用这些药物。合并症包括血液系统恶性肿瘤、实体瘤和控制良好的自身免疫性疾病。对 SARS-CoV-2 药物无反应的患者定义为接受过治疗，但在症状出现后 14 天的 Ct 值<30。患者以 1:1 的比例随机分为罗匹尼罗干扰素 alfa-2b 250μg 加标准治疗 (SOC) 组或 SOC 组。在第 15 天和第 29 天就诊时进行 SARS-CoV-2 抗原检测，以确定是否给予额外的罗匹尼罗干扰素 alfa-2b 剂量。在第 15 天和第 29 天抗原检测阳性的患者将分别接受第 2 剂和第 3 剂罗匹尼罗干扰素 alfa-2b，剂量分别为 350μg 和 500μg。抗原检测阴性但第 15 天和第 29 天逆转录聚合酶链反应 (RT-PCR) 的 Ct 值<30 的患者也给予第 2 剂 (350μg) 和第 3 剂 (500μg)。有 COVID-19 复发/反弹高风险的患者，如免疫功能低下的患者，即使 Ct 值≥30，也将给予额外的罗匹尼罗干扰素 alfa-2b 剂量。大约 60 名患者将被纳入研究。
主要结局是比较罗匹尼罗干扰素 alfa-2b 组和对照组从随机分组到 RT-PCR 检测到 Ct 值≥30 的时间。我们之前的研究表明，在中度或重度 COVID-19 患者中，罗匹尼罗干扰素 alfa-2b 具有安全性和有希望的抗 SARS-CoV-2 活性。本研究将为 COVID-19 合并症患者提供有价值的数据，这些患者急需安全有效的治疗。
本试验在 ClinicalTrials.gov 注册 (标识符 NCT05808322)。
