Safety, Pharmacokinetics, and Preliminary Efficacy of Herbal Products for the Treatment of Acute Respiratory Viral Infections Including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Uganda; Phase 2A Open Label Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events).
研究概览
简要总结
The trial "Safety, Pharmacokinetics and Preliminary Efficacy of herbal products for the treatment of acute respiratory viral infections including SARS-CoV2 in Uganda; Phase 2A Open Label Clinical Trial" is currently being implemented under the Clinical Trials of Natural therapeutics Program. The trial sample size is 510, and the participants include adults (18 years or more) who fulfill the case definitions of acute respiratory infections (ARI), test positive for one of the target respiratory viruses, are negative for TB on GeneXpert; non-pregnant/non-breast-feeding females, have no history of hypersensitivity to any of the investigational products, and have given written consent to participate in the trial.
The overall objective of the trial is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections including (SARS-CoV2, RSV and Influenza A/B) in Uganda.
Primary objectives include:
- To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B
- To determine the extent of SARS-CoV2, RSV, and Influenza A/B viral clearance among adult participants patients with acute viral respiratory infection treated using TAZCOV and Vidicine
- To establish time-to-remission of symptoms among participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine
- To evaluate disease progression among participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine The end points include: Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events), days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment and time to presenting symptom resolution. The Pharmacokinetic endpoints include: the maximum concentration of IMP in plasma [Cmax], time taken for the IMP plasma concentration to reach maximum levels [Tmax] and time taken for the concentration of the IMP in the plasma or the total amount in the body to be reduced by 50%.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALl adults who
- •fulfill ARI case definition
- •have signs and symptoms of ARI
- •test positive for one of the target respiratory viruses (SARS-CoV2, RSV, or Influenza A/B)
- •do not have symptoms suggestive of Pulmonary TB i.e cough for more than 2 weeks, drenching night sweats, evening fevers and marked weight loss.
- •can provide informed consent or have a surrogate or legally appointed representative to give consent
排除标准
- •Severe acute respiratory illness (SARI)-defined as An acute respiratory illness with a history of fever or measured fever of ≥ 38 °C and cough and/or throat with onset within the past 10 days, requiring hospitalization or with SPO2≤92%
- •History of hypersensitivity to the investigational product or components therein
- •Conditions that may be regarded as contraindications to the investigational medicinal product include known allergic reactions and rashes to any herbal medicines and any untoward reactions to any herbal medications such as bleeding, headaches, high blood pressure, heart failure, seizures, agitation, etc.
- •Severe organ impairment (liver, kidney, brain, heart)
- •Inability to return for post-discharge follow-up
- •Females who are pregnant or intend to become pregnant or are breastfeeding during the trial
研究组 & 干预措施
Investigational Medicinal product A (IMP A) + Standard of Care (SoC)
Participants in this arm will receive the both the Investigational medicinal product (IMP A) and the standard of care
干预措施: TAZCOV (Drug)
Investigational Medicinal product B (IMP B) + Standard of Care (SoC)
Participants in this arm will receive the both the Investigational medicinal product (IMP B) and the standard of care
干预措施: Vidicine (Drug)
Standard of care (SoC)
Participants in this arm will receive only the standard of care
干预措施: TAZCOV (Drug)
Standard of care (SoC)
Participants in this arm will receive only the standard of care
干预措施: Vidicine (Drug)
结局指标
主要结局
Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events).
时间窗: 9 months
The outcome measures are cumulative incidences of solicited and unsolicited side effects (mild, moderate, severe adverse events) in the study arms
Days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment
时间窗: 7 days
Will be assessed through ascertaining the proportion with negative PCR on days 3, 5 and 7
Progression to severe-critical ARI requiring hospitalization, oxygen therapy and/or mortality
时间窗: 14 days
To be measured by ascertaining the proportion progressing to severe ARI requiring hospitalization, oxygen therapy and/or mortality
Time taken for TazCoV and Vidicine plasma concentration to reach maximum levels [Tmax]
时间窗: 14 days
To be measured by time to maximum concentration of TazCoV and Vidicine plasma \[Tmax\]
Time to presenting symptom resolution
时间窗: 14 days
Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms
次要结局
未报告次要终点
研究者
Bruce J Kirenga
Prof
Makerere University