Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial
Myung-Ho Kim, Josh Elbaz, Nikolaus Jilg, Jenna L Gustafson, Min Xu, Dilara Hatipoglu, Eric Nohelty, Arthur Y Kim, Raymond T Chung
Frontiers in Medicine, doi:10.3389/fmed.2023.1095828
Background: This study aimed to investigate the efficacy and safety of subcutaneous injection of peginterferon lambda in patients hospitalized with COVID-19. Methods: 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. Results: 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 (p > 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 (p = 0.24). Symptomatic changes did not differ between the two groups. Peginterferon lambda was well tolerated with a few treatment-related adverse effects.
Conclusion: Peginterferon lambda appears to accelerate SARS-CoV-2 viral load decline and improve plasma disease progression markers in hospitalized patients with COVID-19.
Results We enrolled 14 participants admitted to the Massachusetts General Hospital and with COVID-19 between July 14, 2020 and July 16, 2021. The median age was 54.0 (IQR 45.50 to 58.50), 11 participants (78.6%) were male, and 9 (64.3%) were Hispanic (Table 1 ; Supplementary Table 1 ). All 14 randomly assigned participants were initially injected with a placebo or peginterferon lambda within a median of 43.1 h (IQR 35.8 to 48.4) after testing SARS-CoV-2 positive. Thirteen participants (92.9%) completed 14 days of follow up with 1 participant in the placebo group lost to follow up after day 7 (Figure 1 ). The median baseline SARS-CoV-2 viral load was 1.38 log copies per ml (IQR 0.00 to 4.23), with 5 participants (71.4%) in the placebo group and 2 participants (28.6%) in the peginterferon lambda group having undetectable viral load on the day of randomization although they were tested SARS-CoV-2 RNA positive within 48 h of randomization. The median sum of symptom scores was 2.00 (IQR 0.00 to 4.00) in the placebo group and 5.50 (IQR 2.75 to 7.50) in the peginterferon lambda group. Six participants (85.7%) in the peginterferon lambda group and
Ethics statement The studies involving human participants were reviewed and approved by Massachusetts General Hospital. The patients/participants provided their written informed consent to participate in this study.
Author contributions MHK, NJ, AK, and RC contributed to study conception and design. MHK, JE, JG, and EN contributed to..
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'abstract': '<jats:sec><jats:title>Background</jats:title><jats:p>This study aimed to investigate the '
'efficacy and safety of subcutaneous injection of peginterferon lambda in patients '
'hospitalized with '
'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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\u2009h 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 (<jats:italic>p</jats:italic>\u2009&gt;\u20090.05). 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 '
'(<jats:italic>p</jats:italic>\u2009=\u20090.24). Symptomatic changes did not differ between '
'the two groups. Peginterferon lambda was well tolerated with a few treatment-related adverse '
'effects.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Peginterferon '
'lambda appears to accelerate SARS-CoV-2 viral load decline and improve plasma disease '
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