PMID- 37605995
OWN - NLM
STAT- MEDLINE
DCOM- 20230823
LR  - 20230823
IS  - 1096-9071 (Electronic)
IS  - 0146-6615 (Linking)
VI  - 95
IP  - 8
DP  - 2023 Aug
TI  - Efficacy and safety of Oral LL-37 against the Omicron BA.5.1.3 variant of 
      SARS-COV-2: A randomized trial.
PG  - e29035
LID - 10.1002/jmv.29035 [doi]
AB  - Recombinant LL-37 Lactococcus lactis (Oral LL-37) was designed to prevent 
      progression of COVID-19 by targeting virus envelope, however, effectiveness and 
      safety of Oral LL-37 in clinical application was unclear. A total of 238 adult 
      inpatients, open-labelled, randomized, placebo-controlled, single-center study 
      was conducted to investigate the primary end points, including negative 
      conversion time (NCT) of SARS-CoV-2 RNA and adverse events (AEs). As early as 
      intervened on 6th day of case confirmed, Oral LL-37 could significantly shorten 
      NCT (LL-37 9.80 +/- 2.67 vs. placebo 14.04 +/- 5.89, p < 0.01). For Oral LL-37, as 
      early as treated in 6 days, the adjusted hazard ratio (HR) for a primary event of 
      nucleic acid negative outcome was 6.27-fold higher than 7-day-later (HR: 6.276, 
      95% confidence interval [CI]: 3.631-10.848, p < 0.0001), and the adjusted HR of 
      Oral LL-37 within 6 days is higher than placebo (HR: 2.427 95% CI: 1.239-4.751, 
      p = 0.0097). No severe AEs were observed during hospitalization and follow-up 
      investigation. This study shows that early intervention of Oral LL-37 incredibly 
      reduces NCT implying a potential for clearance of Omicron BA.5.1.3 without 
      evident safety concerns.
CI  - (c) 2023 The Authors. Journal of Medical Virology published by Wiley Periodicals 
      LLC.
FAU - Zhao, Yiming
AU  - Zhao Y
AD  - Department of Gastroenterology and Hepatology, Hainan Hospital, Chinese PLA 
      General Hospital, Sanya, Hainan, China.
FAU - Zhang, Hanlin
AU  - Zhang H
AD  - Key Laboratory of Animal Ecology and Conservation Biology, Institute of Zoology, 
      Chinese Academy of Sciences, Beijing, China.
FAU - Zhao, Zhizhuang
AU  - Zhao Z
AD  - Department of Geriatric Medicine, Hainan Hospital, Chinese PLA General Hospital, 
      Sanya, Hainan, China.
FAU - Liu, Fangfang
AU  - Liu F
AD  - Department of Medical Oncology, Fifth Medical Center, Chinese PLA General 
      Hospital, Beijing, China.
FAU - Dong, Meng
AU  - Dong M
AD  - Key Laboratory of Animal Ecology and Conservation Biology, Institute of Zoology, 
      Chinese Academy of Sciences, Beijing, China.
FAU - Chen, Li
AU  - Chen L
AD  - Key Laboratory of Animal Ecology and Conservation Biology, Institute of Zoology, 
      Chinese Academy of Sciences, Beijing, China.
AD  - Savaid Medical School, University of Chinese Academy of Sciences, Beijing, China.
FAU - Shen, Mingzhi
AU  - Shen M
AD  - Department of Cardiovascular Medicine, Hainan Hospital, Chinese PLA General 
      Hospital, Sanya, Hainan, China.
FAU - Luan, Zhe
AU  - Luan Z
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Zhang, Hanwen
AU  - Zhang H
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Wu, Junling
AU  - Wu J
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Li, Congyong
AU  - Li C
AD  - Department of Geriatric Gastroenterology, Sixth Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Chen, Jun
AU  - Chen J
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Li, Chao
AU  - Li C
AD  - Department of Gastroenterology, Hainan Hospital, Chinese PLA General Hospital, 
      Sanya, Hainan, China.
FAU - Liu, Zhiwei
AU  - Liu Z
AD  - Department of General Surgery, Hainan Hospital, Chinese PLA General Hospital, 
      Sanya, Hainan, China.
FAU - Chen, Yi
AU  - Chen Y
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Zheng, Aihua
AU  - Zheng A
AD  - State Key Laboratory of Integrated Management of Pest Insects and Rodents, 
      Institute of Zoology, Chinese Academy of Sciences, Beijing, China.
AD  - CAS Center for Excellence in Biotic Interactions, University of Chinese Academy 
      of Sciences, Beijing, China.
FAU - Li, Huiling
AU  - Li H
AD  - Department of Tropical Medicine, Hainan Hospital, PLA General Hospital, Sanya, 
      Hainan, China.
FAU - Wang, Shufang
AU  - Wang S
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
FAU - Jin, Wanzhu
AU  - Jin W
AD  - Key Laboratory of Animal Ecology and Conservation Biology, Institute of Zoology, 
      Chinese Academy of Sciences, Beijing, China.
FAU - Sun, Gang
AU  - Sun G
AUID- ORCID: 0000-0001-8594-557X
AD  - Department of Gastroenterology and Hepatology, First Medical Center, Chinese PLA 
      General Hospital, Beijing, China.
LA  - eng
SI  - ChiCTR/ChiCTR2200063622
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Med Virol
JT  - Journal of medical virology
JID - 7705876
RN  - 0 (RNA, Viral)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *SARS-CoV-2
MH  - *COVID-19/prevention & control
MH  - RNA, Viral
MH  - Hospitalization
MH  - Inpatients
OTO - NOTNLM
OT  - COVID-19
OT  - adverse effect
OT  - live biotherapeutic products
OT  - negative conversion time
OT  - oral LL-37
EDAT- 2023/08/22 06:42
MHDA- 2023/08/23 06:42
CRDT- 2023/08/22 05:47
PHST- 2023/06/23 00:00 [revised]
PHST- 2023/04/14 00:00 [received]
PHST- 2023/08/03 00:00 [accepted]
PHST- 2023/08/23 06:42 [medline]
PHST- 2023/08/22 06:42 [pubmed]
PHST- 2023/08/22 05:47 [entrez]
AID - 10.1002/jmv.29035 [doi]
PST - ppublish
SO  - J Med Virol. 2023 Aug;95(8):e29035. doi: 10.1002/jmv.29035.