Peginterferon lambda for the treatment of hospitalized patients with mild COVID-19: A pilot phase 2 randomized placebo-controlled trial
Very small RCT with 14 hospitalized patients in the USA showing no significant differences with peginterferon lambda. Viral load was improved, however 86% of treatment versus 14% of control patients received remdesivir, and the median baseline viral load for treatment patients was 3.6 log10 copies/ml versus 0 for control.
risk of ICU admission, 200.0% higher, RR 3.00, p = 1.00, treatment 1 of 7 (14.3%), control 0 of 7 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
hospitalization time, 25.0% higher, relative time 1.25, p = 0.59, treatment median 5.0 IQR 4.0 n=7, control median 4.0 IQR 5.0 n=7.
risk of no viral clearance, 12.5% lower, RR 0.88, p = 1.00, treatment 3 of 6 (50.0%), control 4 of 7 (57.1%), NNT 14, day 14.
risk of no viral clearance, 66.7% higher, RR 1.67, p = 0.59, treatment 5 of 7 (71.4%), control 3 of 7 (42.9%), day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kim et al., 24 Feb 2023, Single Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, median age 54.0, 9 authors, study period 14 July, 2020 - 16 July, 2021, trial NCT04343976 (history)
Abstract: TYPE Clinical Trial
PUBLISHED 24 February 2023
Shisan (Bob) Bao,
The University of Sydney,
Queen's University Belfast,
Bryan D. Kraft,
Raymond T. Chung
Peginterferon lambda for the
treatment of hospitalized patients
with mild COVID-19: A pilot phase
2 randomized placebo-controlled
Myung-Ho Kim 1,2, Josh Elbaz 1,3, Nikolaus Jilg 4,5,
Jenna L. Gustafson 1,5, Min Xu 1,5, Dilara Hatipoglu 5, Eric Nohelty 4,5,
Arthur Y. Kim 4,5 and Raymond T. Chung 1,5*
Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Harvard Medical School,
Boston, MA, United States, 2 Department of Internal Korean Medicine, Woosuk University Medical
Center, Jeonju, Republic of Korea, 3 Department of Medicine, Donald and Barbara Zucker School of
Medicine at Hofstra/Northwell, Hempstead, NY, United States, 4 Division of Infectious Disease,
Massachusetts General Hospital, Harvard Medical School Boston, Boston, MA, United States,
Department of Medicine, Massachusetts General Hospital, Boston, MA, United States
This article was submitted to
Infectious Diseases: Pathogenesis and Therapy,
a section of the journal
Frontiers in Medicine
RECEIVED 11 November 2022
ACCEPTED 08 February 2023
PUBLISHED 24 February 2023
Kim MH, Elbaz J, Jilg N, Gustafson JL, Xu M,
Hatipoglu D, Nohelty E, Kim AY and
Chung RT (2023) Peginterferon lambda for the
treatment of hospitalized patients with mild
COVID-19: A pilot phase 2 randomized
Front. Med. 10:1095828.
© 2023 Kim, Elbaz, Jilg, Gustafson, Xu,
Hatipoglu, Nohelty, Kim and Chung. This is an
open-access article distributed under the terms
of the Creative Commons Attribution License
(CC BY). The use, distribution or reproduction
in other forums is permitted, provided the
original author(s) and the copyright owner(s)
are credited and that the original publication in
this journal is cited, in accordance with
accepted academic practice. No use,
distribution or reproduction is permitted which
does not comply with these terms.
Background: This study aimed to investigate the efficacy and safety of
subcutaneous injection of peginterferon lambda in patients hospitalized with
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 48h 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..
is less effective
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