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

Обзор

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

Вмешательства

• Препарат NRICM102
  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
• Препарат Placebo
  Placebo
• Препарат Intravenous Antibiotic
  Intravenous Antibiotic

Первичные конечные точки

• Time from initiation of treatment to clinical stability [Срок оценки: 30 Days]

Вторичные конечные точки (8)

• Clinical success rate on Day 4 and Day 8 (Clinical Success) [Срок оценки: 8 Days]
• Subjective assessment of clinical success [Срок оценки: 8 Days]
• Improvement rate based on chest X-ray findings [Срок оценки: 8 Days]
• Rate of hospital readmission within 30 days from the initiation of treatment [Срок оценки: 30 Days]
• Mortality within 30 days from the initiation of treatment [Срок оценки: 30 Days]
• ICU admission rate within 30 days from the initiation of treatment [Срок оценки: 30 Days]
• Time to IV switch from intravenous (IV) to oral antibiotics [Срок оценки: 30 Days]
• Length of hospitalization [Срок оценки: 30 Days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.\*
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

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

Публикации

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Идентификаторы

NCT: NCT07583992 · NRICM102-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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