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Mild to ModeratePhase 2NCT07583992

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

A Phase 2 study testing NRICM102 and Intravenous Antibiotic in people with Mild to Moderate and Community-Acquired Pneumonia (CAP), run by National Research Institute of Chinese Medicine, Ministry of Health and Welfare at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
NRICM102 and Intravenous Antibiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteTaiwan
Study dates
Jun 2026to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18 to 85 years
  • The subjects are diagnosed with community-acquired pneumonia (CAP) at the time of hospital admission and must meet all of the following criteria:
  • Chest X-ray showing new onset or persistent pulmonary infiltrate At least two of the following abnormal clinical or laboratory findings: (a) Cough, (b) Sputum production, (c) Fever (≥37.8℃) or hypothermia (<35℃), (d) Auscultatory findings of rales or bronchial breath sounds, (e) White blood cell count greater than 10×10⁹/L or less than 4×10⁹/L
  • Subjects requiring hospitalization and intravenous antibiotic therapy
  • Subjects who have received standard antibiotic therapy for less than 24 hours after hospital admission
  • Subjects who are able to take the investigational product orally
  • Subjects who are able to understand and comply with all study procedures and provide written informed consent

Who cannot join

  • Subjects who have received systemic antibiotic treatment within 72 hours prior to screening; routine antibiotics administered after hospital admission are not included in this restriction
  • Subjects who have used oral traditional Chinese medicine (TCM) or traditional Chinese medicine preparations that may affect efficacy assessment within 7 days prior to hospital admission
  • Subjects who have been hospitalized within 15 days prior to current admission
  • Subjects with aspiration pneumonia
  • Subjects requiring admission to the intensive care unit (ICU)
  • Subjects requiring hemodialysis
Show all 17Show fewer
  • Subjects with any malignancy, except those who have completed curative treatment with no signs of recurrence for more than five years and require no further anticancer therapy (based on medical history)
  • Subjects with human immunodeficiency virus (HIV) infection
  • Subjects requiring long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), steroids, or other immunosuppressants
  • Subjects requiring antiviral agents for COVID-19 infection or influenza
  • Subjects must be on a stable dose of Omeprazole or Warfarin
  • Subjects with alcohol or substance abuse, or other major organic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, tuberculosis (TB), or significant heart, kidney, or other major organ dysfunction or failure (based on medical history)
  • Female subjects who are pregnant, breastfeeding, or of childbearing potential, or those intending to become pregnant between the signing of the Informed Consent Form (ICF) and the final observation/study time point, or who are unwilling to use an appropriate method of contraception. Acceptable highly effective methods of contraception include:
  • Surgical sterilization (male or female), contraceptive implants, or intrauterine devices (IUDs).
  • Injectable contraceptives, oral contraceptives, contraceptive patches, or vaginal rings, used in combination with one barrier method.*
  • Combination of two barrier methods.* *Effective barrier methods include diaphragms, male or female condoms, contraceptive sponges, or spermicides (creams or gels containing spermicidal chemicals).
  • Subjects deemed unsuitable for study participation by the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site

  • National Research Institute of Chinese Medicine, Ministry of Health and Welfare

    Taipei, 11221

    Yi-Chang Su, MD, PhD, 886-2-2820-1999 ext 3101, sychang@nricm.edu.tw

Other trials in Taiwan

About this study

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?
Read more

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
Being tested
NRICM102, Placebo, Intravenous Antibiotic
Keywords
NRICM102, Community-Acquired Pneumonia (CAP), National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRICM102Drug

    1. Name: NRICM102
    2. Dosage form: Concentrated granules
    3. Unit Content: 5 grams/sachet
    4. Dosing schedule: Oral administration, 2 sachets per dose, 3 times daily (total daily dose: 30 grams), for a duration of 7 days
    5. Mechanism of action: The main ingredients are believed to inhibit the interaction between the SARS-CoV-2 spike protein and the human angiotensin-converting enzyme 2 (ACE2) receptor, thereby reducing viral entry into host cells. Inhibition of the 3CL protease may suppress viral replication. Additionally, the formulation downregulates inflammatory mediators such as IL-6 and TNF-α, and offers lung protection, anti-fibrotic effects, and potential thrombosis modulation. These properties suggest immunomodulatory and pulmonary protective functions, supporting its use as adjunct therapy in pneumonia.
    6. Pharmacological Classification: Traditional Chinese Medicine

  • PlaceboDrug

    Placebo

  • Intravenous AntibioticDrug

    Intravenous Antibiotic

Study groups in NCT07583992
Study groupRoleWhat they receive
NRICM102ExperimentalNot described
Receives: Drug: NRICM102; Drug: Intravenous Antibiotic
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Intravenous Antibiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from initiation of treatment to clinical stability

    "Clinical Stability" is defined as the maintenance of all the following criteria for more than 24 consecutive hours: Body Temperature < 37.8 °C Heart Rate < 100 beats per minute Respiratory Rate < 24 breaths per minute Systolic Blood Pressure > 90 mmHg Blood Oxygen Saturation > 90% on room air (FiO₂: 21%) Able to Eat Orally Alert

    Measured: 30 Days

Secondary outcomes (8)

  1. Clinical success rate on Day 4 and Day 8 (Clinical Success)

    Assessed symptoms include: cough, sputum production, difficulty breathing, and chest pain Clinical success is defined as improvement in at least two of the four assessed symptoms, with no worsening in any symptom Symptom severity is categorized into four levels (None, Mild, Moderate, Severe). An improvement is defined as a decrease of at least one severity level compared to baseline

    Measured: 8 Days

  2. Subjective assessment of clinical success

    Subjective symptoms include: cough, sputum production, difficulty breathing, and chest pain Subjects will rate these symptoms using a Visual Analog Scale (VAS) Symptom assessment is based on the change in score from baseline

    Measured: 8 Days

  3. Improvement rate based on chest X-ray findings

    Measured: 8 Days

  4. Rate of hospital readmission within 30 days from the initiation of treatment

    Measured: 30 Days

  5. Mortality within 30 days from the initiation of treatment

    Measured: 30 Days

  6. ICU admission rate within 30 days from the initiation of treatment

    Measured: 30 Days

  7. Time to IV switch from intravenous (IV) to oral antibiotics

    Measured: 30 Days

  8. Length of hospitalization

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will receive standard intravenous antibiotic treatment and will be randomly assigned (1:1 ratio) to receive either NRICM102 or placebo for 7 days. The investigational product will be administered orally, 2 sachets (10 g total) three times daily. Subjects whose clinical condition meets the definition of clinical stability for more than 24 hours, and who are deemed stable by the principal investigator, may be transitioned to oral antibiotics or discharged.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583992
Sponsor's protocol ID
NRICM102-201
Status last verified
Apr 2026
First submitted
7 May 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU. Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med. 2005 Feb 1;171(3):242-8. doi: 10.1164/rccm.200406-808OC. Epub 2004 Nov 19.

    PubMed 15557131

  • 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.

    PubMed 9600479

  • Fernandez-Serrano S, Dorca J, Garcia-Vidal C, Fernandez-Sabe N, Carratala J, Fernandez-Aguera A, Corominas M, Padrones S, Gudiol F, Manresa F. Effect of corticosteroids on the clinical course of community-acquired pneumonia: a randomized controlled trial. Crit Care. 2011 Mar 15;15(2):R96. doi: 10.1186/cc10103.

    PubMed 21406101

  • 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.

    PubMed 8959115

  • 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.

    PubMed 34726479

  • 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.

    PubMed 36566761

  • 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.

    PubMed 32649078

  • 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.

    PubMed 32676976

  • 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.

    PubMed 37138292

  • 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.

    PubMed 36007774

  • 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.

    PubMed 37147240

  • 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.

    PubMed 36064077

  • 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.

    PubMed 33249281

  • 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.

    PubMed 25485813

  • 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.

    PubMed 22389696

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NRICM102 and Intravenous Antibiotic in people with Mild to Moderate and Community-Acquired Pneumonia (CAP), run by National Research Institute of Chinese Medicine, Ministry of Health and Welfare at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from initiation of treatment to clinical stability (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07583992, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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