Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial
BackgroundThis study aimed to investigate the efficacy and safety of subcutaneous injection of peginterferon lambda in patients hospitalized with COVID-19.MethodsIn this study (NCT04343976), patients admitted to hospital with COVID-19 confirmed by RT-PCR from nasopharyngeal swab were randomly assign...
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Frontiers Media S.A.
2023-02-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1095828/full |
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| author | Myung-Ho Kim Myung-Ho Kim Josh Elbaz Josh Elbaz Nikolaus Jilg Nikolaus Jilg Jenna L. Gustafson Jenna L. Gustafson Min Xu Min Xu Dilara Hatipoglu Eric Nohelty Eric Nohelty Arthur Y. Kim Arthur Y. Kim Raymond T. Chung Raymond T. Chung |
| author_facet | Myung-Ho Kim Myung-Ho Kim Josh Elbaz Josh Elbaz Nikolaus Jilg Nikolaus Jilg Jenna L. Gustafson Jenna L. Gustafson Min Xu Min Xu Dilara Hatipoglu Eric Nohelty Eric Nohelty Arthur Y. Kim Arthur Y. Kim Raymond T. Chung Raymond T. Chung |
| author_sort | Myung-Ho Kim |
| collection | DOAJ |
| description | BackgroundThis study aimed to investigate the efficacy and safety of subcutaneous injection of peginterferon lambda in patients hospitalized with COVID-19.MethodsIn 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.ResultsWe 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.ConclusionPeginterferon lambda appears to accelerate SARS-CoV-2 viral load decline and improve plasma disease progression markers in hospitalized patients with COVID-19. |
| first_indexed | 2024-04-10T07:26:15Z |
| format | Article |
| id | doaj.art-466324e1c1d94773ba9fdb9ffb4e9298 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-10T07:26:15Z |
| publishDate | 2023-02-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Medicine |
| spelling | doaj.art-466324e1c1d94773ba9fdb9ffb4e92982023-02-24T05:59:13ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-02-011010.3389/fmed.2023.10958281095828Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trialMyung-Ho Kim0Myung-Ho Kim1Josh Elbaz2Josh Elbaz3Nikolaus Jilg4Nikolaus Jilg5Jenna L. Gustafson6Jenna L. Gustafson7Min Xu8Min Xu9Dilara Hatipoglu10Eric Nohelty11Eric Nohelty12Arthur Y. Kim13Arthur Y. Kim14Raymond T. Chung15Raymond T. Chung16Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United StatesDepartment of Internal Korean Medicine, Woosuk University Medical Center, Jeonju, Republic of KoreaLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United StatesDepartment of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United StatesDivision of Infectious Disease, Massachusetts General Hospital, Harvard Medical School Boston, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesDivision of Infectious Disease, Massachusetts General Hospital, Harvard Medical School Boston, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesDivision of Infectious Disease, Massachusetts General Hospital, Harvard Medical School Boston, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesLiver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United StatesDepartment of Medicine, Massachusetts General Hospital, Boston, MA, United StatesBackgroundThis study aimed to investigate the efficacy and safety of subcutaneous injection of peginterferon lambda in patients hospitalized with COVID-19.MethodsIn 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.ResultsWe 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.ConclusionPeginterferon lambda appears to accelerate SARS-CoV-2 viral load decline and improve plasma disease progression markers in hospitalized patients with COVID-19.https://www.frontiersin.org/articles/10.3389/fmed.2023.1095828/fullCOVID-19peginterferon lambdaSARS-CoV-2 viral loadIP-10 (CXCL-10)CXCL9(C-X-C motif) ligand 9 |
| spellingShingle | Myung-Ho Kim Myung-Ho Kim Josh Elbaz Josh Elbaz Nikolaus Jilg Nikolaus Jilg Jenna L. Gustafson Jenna L. Gustafson Min Xu Min Xu Dilara Hatipoglu Eric Nohelty Eric Nohelty Arthur Y. Kim Arthur Y. Kim Raymond T. Chung Raymond T. Chung Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial Frontiers in Medicine COVID-19 peginterferon lambda SARS-CoV-2 viral load IP-10 (CXCL-10) CXCL9 (C-X-C motif) ligand 9 |
| title | Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial |
| title_full | Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial |
| title_fullStr | Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial |
| title_full_unstemmed | Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial |
| title_short | Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial |
| title_sort | peginterferon lambda for the treatment of hospitalized patients with mild covid 19 a pilot phase 2 randomized placebo controlled trial |
| topic | COVID-19 peginterferon lambda SARS-CoV-2 viral load IP-10 (CXCL-10) CXCL9 (C-X-C motif) ligand 9 |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1095828/full |
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