Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Amplicon Sequence Variants (ASVs) That Are Significantly Correlated With Variation in the Microbiome Data Between NBT-NM108 Group and Usual Care Only Group From Day 0 to 28
研究概览
简要总结
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 to 79 (inclusive)
- •Have mild to moderate COVID-19-like symptoms based on the symptom list from CDC (updated May 13, 2020) and the severity categorization from FDA [18]:
- •a) Mild COVID-19
- •Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea
- •No clinical signs indicative of moderate, severe, or critical illness severity
- •b) Moderate COVID-19
- •Symptoms of moderate illness with COVID-19 could include any symptom of mild illness or shortness of breath with exertion
- •Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths/min, oxygen saturation level > 93% on room air at sea level, heart rate ≥ 90 beats/min
- •No clinical signs indicative of severe or critical illness severity
- •Directed to home isolation by study physician
- •Confirm study enrollment within 7 days of symptom onset
- •Practice acceptable contraception, i.e., continue with current methods if participants are already practicing contraception, otherwise participants must agree to practicing contraception with a barrier method (male or female condom) or abstinence, from Day 1 to Day 35 or 7 days after the last dose of NBT-NM108 if they do not complete the 28-day intervention.
- •Have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and daily internet access
- •Understand and be able to follow written and oral instructions in English
- •Provide informed consent
- •Exclusion Criteria
- •Have tested positive for COVID-19 and recovered
- •Receiving vancomycin monotherapy or oral broad-spectrum antibiotics
- •Inability to receive oral fluids
- •Self-reported allergy or intolerance to any ingredients in NBT-NM108
- •Surgery involving the intestinal lumen within the last 30 days
- •Documented diagnosis of celiac disease, inflammatory bowel disease or irritable bowel syndrome
- •Pregnancy or breastfeeding
- •Bariatric surgery
- •Immunocompromised, e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other immunosuppressant medications
排除标准
- 未提供
研究组 & 干预措施
NBT-NM108 + Usual Care
干预措施: NBT-NM108 (Drug)
Usual Care Only
干预措施: Usual Care Only (Other)
结局指标
主要结局
Amplicon Sequence Variants (ASVs) That Are Significantly Correlated With Variation in the Microbiome Data Between NBT-NM108 Group and Usual Care Only Group From Day 0 to 28
时间窗: Day 0-28
Amplicon Sequence Variants (ASVs) significantly correlated with the first principal coordinate (PC1) from the covariate-adjusted Principal Coordinates Analysis (aPCoA) were identified, each having an average relative abundance greater than 0.001%. These ASVs represent specific microbial features whose relative abundance was most strongly associated with the primary axis of variation in the microbiome data, after adjusting for covariates. It was hypothesized that PC1 might reflect the direction of microbiome changes induced by the intervention, given its association with shifts observed in participants' microbiome compositions before and after the intervention. The unit of measure used here is the relative abundance percentage of each ASV in the stool sample.
次要结局
- Number of Participants That Were Hospitalized or Died From COVID19(At days 0, 14, 28, and 56)
- Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"(At days 0, 14, 28, and 56)
- Number of Participants Who Visited the Emergency Room From COVID-19(At days 0, 14, 28, and 56)
- Proportion of Participants Who Have Complete Resolution of Objective Symptoms(At days 28 and 56)
- Proportion of Participants Who Have Complete Resolution of Subjective Symptoms(At days 28 and 56)
- Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough(At days 28 and 56)
- Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document(Day 0)
- Oral Body Temperature (F)(At days 0, 14, 28, and 56)
- Oxygen Saturation SpO2 Level(At days 0, 14, 28, and 56)
- Pulse Rate Per Minute(At days 0, 14, 28, and 56)
- Respiratory Rate Per Minute(At days 0, 14, 28, and 56)
- Fasting Blood Glucose(At days 0 and 28)