Kim Myung-Ho, Elbaz Josh, Jilg Nikolaus, Gustafson Jenna L, Xu Min, Hatipoglu Dilara, Nohelty Eric, Kim Arthur Y, Chung Raymond T
Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.
Department of Internal Korean Medicine, Woosuk University Medical Center, Jeonju, Republic of Korea.
Front Med (Lausanne). 2023 Feb 24;10:1095828. doi: 10.3389/fmed.2023.1095828. eCollection 2023.
This study aimed to investigate the efficacy and safety of subcutaneous injection of peginterferon lambda in patients hospitalized with COVID-19.
In this study (NCT04343976), patients admitted to hospital with COVID-19 confirmed by RT-PCR from nasopharyngeal swab were randomly assigned within 48 h to receive peginterferon lambda or placebo in a 1:1 ratio. Participants were subcutaneously injected with a peginterferon lambda or saline placebo at baseline and day 7 and were followed up until day 14.
We enrolled 14 participants; 6 participants (85.7%) in the peginterferon lambda group and 1 participant (14.3%) in the placebo group were treated with remdesivir prior to enrollment. Fifty percent of participants were SARS-CoV-2 RNA negative at baseline although they tested SARS-CoV-2 RNA positive within 48 h of randomization. Among participants who were SARS-CoV-2 positive at baseline, 2 out of 5 participants (40%) in the peginterferon lambda group became negative at day 14, while 0 out of 2 participants (0%) in the placebo group achieved negativity for SARS-CoV-2 by day 14 ( > 0.05). The median change in viral load (log copies per ml) was +1.72 (IQR -2.78 to 3.19) in the placebo group and -2.22 (IQR -3.24 to 0.55) in the peginterferon lambda group at day 14 ( = 0.24). Symptomatic changes did not differ between the two groups. Peginterferon lambda was well tolerated with a few treatment-related adverse effects.
Peginterferon lambda appears to accelerate SARS-CoV-2 viral load decline and improve plasma disease progression markers in hospitalized patients with COVID-19.
本研究旨在调查皮下注射聚乙二醇化干扰素λ对新冠肺炎住院患者的疗效和安全性。
在本研究（NCT04343976）中，经鼻咽拭子RT-PCR确诊为新冠肺炎的住院患者在48小时内被随机分配，以1:1的比例接受聚乙二醇化干扰素λ或安慰剂治疗。参与者在基线和第7天接受皮下注射聚乙二醇化干扰素λ或生理盐水安慰剂，并随访至第14天。
我们招募了14名参与者；聚乙二醇化干扰素λ组的6名参与者（85.7%）和安慰剂组的1名参与者（14.3%）在入组前接受了瑞德西韦治疗。50%的参与者在基线时SARS-CoV-2 RNA呈阴性，尽管他们在随机分组后48小时内检测SARS-CoV-2 RNA呈阳性。在基线时SARS-CoV-2呈阳性的参与者中，聚乙二醇化干扰素λ组的5名参与者中有2名（40%）在第14天转为阴性，而安慰剂组的2名参与者中没有1名（0%）在第14天实现SARS-CoV-2转阴（P>0.05）。在第14天，安慰剂组的病毒载量中位数变化（每毫升对数拷贝数）为+1.72（IQR -2.78至3.19），聚乙二醇化干扰素λ组为-2.22（IQR -3.24至0.55）（P=0.24）。两组的症状变化没有差异。聚乙二醇化干扰素λ耐受性良好，有一些与治疗相关的不良反应。
聚乙二醇化干扰素λ似乎能加速新冠肺炎住院患者的SARS-CoV-2病毒载量下降，并改善血浆疾病进展标志物。
