Efficacy and safety of Oral LL-37 against the Omicron BA.5.1.3 variant of SARS-COV-2: A randomized trial.
Zhao. Yiming Y; Zhang. Hanlin H; Zhao. Zhizhuang Z; Liu. Fangfang F; Dong. Meng M; Chen. Li L; Shen. Mingzhi M; Luan. Zhe Z; Zhang. Hanwen H; Wu. Junling J; Li. Congyong C; Chen. Jun J; Li. Chao C; Liu. Zhiwei Z; Chen. Yi Y; Zheng. Aihua A; Li. Huiling H; Wang. Shufang S; Jin. Wanzhu W; Sun. Gang G
Key Findings
- Oral LL‑37 started within 6 days of COVID‑19 diagnosis cut the average time to a negative PCR from ~14 days to ~10 days.
- The adjusted hazard ratio for viral clearance was 6.27 when treatment began early, and 2.43 compared with placebo.
- No severe adverse events were reported during hospitalization or follow‑up.
Practical Outcomes
- Early use of oral LL‑37 may help speed up viral clearance in COVID‑19 without obvious safety concerns, but the product isn’t widely available and the study was limited to hospitalized patients. Biohackers could view this as a promising adjunct, yet more data and access are needed before it can be recommended as a routine home‑based protocol.
Summary
A clinical trial gave COVID‑19 patients a pill containing the antimicrobial peptide LL‑37 made by a friendly bacteria. When the pill was started within six days of diagnosis, patients cleared the virus about five days faster than those who got a placebo, and no serious side effects were seen.
Abstract
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.
Study Information
pubmed
2023
2023-08-01T00:00:00.000Z
10.1002/jmv.29035
7
33