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

NCT07583992 | Not Yet Recruiting Phase 2

• 1 other identifier: NRICM102-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does NRICM102 help participants reach clinical stability faster compared to placebo?
2. 2.What medical problems do participants have when taking NRICM102?
3. 3.Take NRICM102 or a placebo (2 sachets, 3 times daily) in addition to standard intravenous antibiotic treatment for 7 days
4. 4.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
5. 5.Be contacted by telephone on Day 30 to check if they were readmitted to the hospital after discharge

Conditions

Mild to Moderate; Community-Acquired Pneumonia (CAP); Intravenous; Hospitalisation; Antibiotic Therapy

Keywords

NRICM102; Community-Acquired Pneumonia (CAP); National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Outcome Measures

Primary Outcomes (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

  30 Days

Secondary Outcomes (8)

• Clinical success rate on Day 4 and Day 8 (Clinical Success)

  8 Days

• Subjective assessment of clinical success

  8 Days

• Improvement rate based on chest X-ray findings

  8 Days

• Rate of hospital readmission within 30 days from the initiation of treatment

  30 Days

• Mortality within 30 days from the initiation of treatment

  30 Days

Study Arms (2)

NRICM102

EXPERIMENTAL

Drug: NRICM102; Drug: Intravenous Antibiotic

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Intravenous Antibiotic

Interventions

NRICM102 DRUG

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

NRICM102

Placebo DRUG

Placebo

Placebo

Intravenous Antibiotic DRUG

Intravenous Antibiotic

NRICM102; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.\*

Sponsors & Collaborators

• National Research Institute of Chinese Medicine, Ministry of Health and Welfare: lead
• StatPlus,Inc.: collaborator

Study Sites (1)

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

Taipei, 11221, Taiwan

Location

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MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-04

Locations

TW (1)