Multicenter Phase II Trial of NRICM102 Combined With Standard Therapy in Pneumonia

Summary

The goal of this clinical trial is to learn if NRICM102 (a Traditional Chinese Medicine) works to treat community-acquired pneumonia (CAP) in adults when added to standard antibiotic therapy. It will also learn about the safety of NRICM102. The main questions it aims to answer are: 1. Does NRICM102 help participants reach clinical stability faster compared to placebo? 2. What medical problems do participants have when taking NRICM102? Researchers will compare NRICM102 to a placebo (a look-alike substance that contains no drug) to see if NRICM102 works as an add-on treatment for community-acquired pneumonia. Participants will: 1. Take NRICM102 or a placebo (2 sachets, 3 times daily) in addition to standard intravenous antibiotic treatment for 7 days 2. Be hospitalized and visited by the study team on Day 1, Day 4, and Day 8 for vital sign monitoring, symptom assessments, laboratory tests, and chest X-ray examinations 3. Be contacted by telephone on Day 30 to check if they were readmitted to the hospital after discharge

Timeline

Start

2026-06

Primary completion

2027-03

Completion

2027-11

Publications

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• Background Halm EA, Fine MJ, Marrie TJ, Coley CM, Kapoor WN, Obrosky DS, Singer DE. Time to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines. JAMA. 1998 May 13;279(18):1452-7. doi: 10.1001/jama.279.18.1452.
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• Background Daifuku R, Movahhed H, Fotheringham N, Bear MB, Nelson S. Time to resolution of morbidity: an endpoint for assessing the clinical cure of community-acquired pneumonia. Respir Med. 1996 Nov;90(10):587-92. doi: 10.1016/s0954-6111(96)90016-5.
• Background Owen DR, Allerton CMN, Anderson AS, Aschenbrenner L, Avery M, Berritt S, Boras B, Cardin RD, Carlo A, Coffman KJ, Dantonio A, Di L, Eng H, Ferre R, Gajiwala KS, Gibson SA, Greasley SE, Hurst BL, Kadar EP, Kalgutkar AS, Lee JC, Lee J, Liu W, Mason SW, Noell S, Novak JJ, Obach RS, Ogilvie K, Patel NC, Pettersson M, Rai DK, Reese MR, Sammons MF, Sathish JG, Singh RSP, Steppan CM, Stewart AE, Tuttle JB, Updyke L, Verhoest PR, Wei L, Yang Q, Zhu Y. An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19. Science. 2021 Dec 24;374(6575):1586-1593. doi: 10.1126/science.abl4784. Epub 2021 Nov 2.
• Background Butler CC, Hobbs FDR, Gbinigie OA, Rahman NM, Hayward G, Richards DB, Dorward J, Lowe DM, Standing JF, Breuer J, Khoo S, Petrou S, Hood K, Nguyen-Van-Tam JS, Patel MG, Saville BR, Marion J, Ogburn E, Allen J, Rutter H, Francis N, Thomas NPB, Evans P, Dobson M, Madden TA, Holmes J, Harris V, Png ME, Lown M, van Hecke O, Detry MA, Saunders CT, Fitzgerald M, Berry NS, Mwandigha L, Galal U, Mort S, Jani BD, Hart ND, Ahmed H, Butler D, McKenna M, Chalk J, Lavallee L, Hadley E, Cureton L, Benysek M, Andersson M, Coates M, Barrett S, Bateman C, Davies JC, Raymundo-Wood I, Ustianowski A, Carson-Stevens A, Yu LM, Little P; PANORAMIC Trial Collaborative Group. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet. 2023 Jan 28;401(10373):281-293. doi: 10.1016/S0140-6736(22)02597-1. Epub 2022 Dec 22.
• Background Beigel JH, Tomashek KM, Dodd LE. Remdesivir for the Treatment of Covid-19 - Preliminary Report. Reply. N Engl J Med. 2020 Sep 3;383(10):994. doi: 10.1056/NEJMc2022236. Epub 2020 Jul 10. No abstract available.
• Background Wang JB, Wang ZX, Jing J, Zhao P, Dong JH, Zhou YF, Yang G, Niu M, Zhao X, Jiang TJ, Bi JF, Xu Z, Zhang P, Wu D, Bai ZF, Guo YM, Yu SM, Sun YQ, Zhang ZT, Zhan XY, Li PY, Ding JB, Zhao PF, Song XA, Tang JY, He DC, Chen Z, Qin EQ, Wang RL, Xiao XH. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial. Chin J Integr Med. 2020 Sep;26(9):648-655. doi: 10.1007/s11655-020-3426-7. Epub 2020 Jul 16.
• Background Lin JG, Huang GJ, Su YC. Efficacy analysis and research progress of complementary and alternative medicines in the adjuvant treatment of COVID-19. J Biomed Sci. 2023 May 3;30(1):30. doi: 10.1186/s12929-023-00923-5.
• Background Tseng YH, Lin SJ, Hou SM, Wang CH, Cheng SP, Tseng KY, Lee MY, Lee SM, Huang YC, Lin CJ, Lin CK, Tsai TL, Lin CS, Cheng MH, Fong TS, Tsai CI, Lu YW, Lin JC, Huang YW, Hsu WC, Kuo HH, Wang LH, Liaw CC, Wei WC, Tsai KC, Shen YC, Chiou WF, Lin JG, Su YC. Curbing COVID-19 progression and mortality with traditional Chinese medicine among hospitalized patients with COVID-19: A propensity score-matched analysis. Pharmacol Res. 2022 Oct;184:106412. doi: 10.1016/j.phrs.2022.106412. Epub 2022 Aug 23.
• Background Ho ST, Tsai YN, Su YC. The development and application of NRICM101 and NRICM102 for the treatment of COVID-19. J Formos Med Assoc. 2023 Jul;122(7):525-527. doi: 10.1016/j.jfma.2023.04.015. Epub 2023 Apr 26. No abstract available.
• Background Wei WC, Liaw CC, Tsai KC, Chiou CT, Tseng YH, Chiou WF, Lin YC, Tsai CI, Lin CS, Lin CS, Liou KT, Yu IS, Shen YC, Su YC. Targeting spike protein-induced TLR/NET axis by COVID-19 therapeutic NRICM102 ameliorates pulmonary embolism and fibrosis. Pharmacol Res. 2022 Oct;184:106424. doi: 10.1016/j.phrs.2022.106424. Epub 2022 Sep 5.
• Background Tsai KC, Huang YC, Liaw CC, Tsai CI, Chiou CT, Lin CJ, Wei WC, Lin SJ, Tseng YH, Yeh KM, Lin YL, Jan JT, Liang JJ, Liao CC, Chiou WF, Kuo YH, Lee SM, Lee MY, Su YC. A traditional Chinese medicine formula NRICM101 to target COVID-19 through multiple pathways: A bedside-to-bench study. Biomed Pharmacother. 2021 Jan;133:111037. doi: 10.1016/j.biopha.2020.111037. Epub 2020 Nov 19.
• Background Sayah DM, Mallavia B, Liu F, Ortiz-Munoz G, Caudrillier A, DerHovanessian A, Ross DJ, Lynch JP 3rd, Saggar R, Ardehali A; Lung Transplant Outcomes Group Investigators; Ware LB, Christie JD, Belperio JA, Looney MR. Neutrophil extracellular traps are pathogenic in primary graft dysfunction after lung transplantation. Am J Respir Crit Care Med. 2015 Feb 15;191(4):455-63. doi: 10.1164/rccm.201406-1086OC.
• Background Saffarzadeh M, Juenemann C, Queisser MA, Lochnit G, Barreto G, Galuska SP, Lohmeyer J, Preissner KT. Neutrophil extracellular traps directly induce epithelial and endothelial cell death: a predominant role of histones. PLoS One. 2012;7(2):e32366. doi: 10.1371/journal.pone.0032366. Epub 2012 Feb 28.
• Background Lefrancais E, Mallavia B, Zhuo H, Calfee CS, Looney MR. Maladaptive role of neutrophil extracellular traps in pathogen-induced lung injury. JCI Insight. 2018 Feb 8;3(3):e98178. doi: 10.1172/jci.insight.98178. eCollection 2018 Feb 8.
• Background Narasaraju T, Yang E, Samy RP, Ng HH, Poh WP, Liew AA, Phoon MC, van Rooijen N, Chow VT. Excessive neutrophils and neutrophil extracellular traps contribute to acute lung injury of influenza pneumonitis. Am J Pathol. 2011 Jul;179(1):199-210. doi: 10.1016/j.ajpath.2011.03.013. Epub 2011 May 7.
• Background Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.

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