Evaluation of the Clinical Outcomes and the Quality of Life of Patients Exhibiting Symptoms Characteristic of Viral Respiratory Infection (VRI), Including Infection by SARS-CoV-2 (COVID-19), and Assessment of the Clinical Effectiveness of a Herbal Extract (Cretan IAMA) in These Patients and the People Cohabiting With Them Via an Open-label, Single-arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with symptom resolution
研究概览
简要总结
This single-arm, open-label small interventional proof-of-concept (POC) study study aims:
- to assess the clinical outcomes of patients exhibiting viral respiratory infection (VRI) symptoms and seeking primary healthcare (PHC) services at the time of the COVID-19 pandemic,
- to assess the clinical effectiveness of the Cretan IAMA (CAPeo), a herbal extract combination, for these patients, including in terms of symptom resolution (symptom frequency, duration) and intensity), and
- to investigate its prophylactic effect in terms of transmission prevention for people cohabiting with the patients exhibiting VRI symptoms.
详细描述
Cretan IAMA (CAPeo) is an essential oil mixture of three native herbs of Crete (Thymbra capitata (L.) Cav., Salvia fruticosa Mill. and Origanum dictamnus L.), which exhibits remarkable in vitro antiviral activity against Influenza A & B and the Human Rhinovirus HRV-14 strains, decreasing the symptoms of upper respiratory tract viral infections. It has also been proven safe in experimental animals and humans. There is currently a strong unmet medical need for safe and effective therapeutic regimens for patients in ambulatory settings. Given its properties, it was, therefore, deemed both appropriate and urgent to explore its potential in the context of COVID-19 for patients in primary care settings. It was also deemed important to investigate the Cretan IAMA (CAPeo) regarding prophylactic treatment for people coming in close contact with these ambulatory patients.
- Single-arm, open label (proof-of-concept) study to assess the potential of Cretan IAMA (CAPeo) benefit of COVID-19 as a therapeutic and prophylactic agent
- VRI/COVID-19 patients seeking primary health care services at home
- SARS-CoV-2 infection testing by real-time RT-PCR, performed in the regional COVID-19 reference centre (Laboratory of Clinical Virology, University of Crete, School of Medicine)
- Cretan IAMA (CAPeo) to be administered in the form of two 0.5 ml soft capsules, in a concentration of 15 ml/L, daily for two weeks (14 days), per os
- Data collection on Day 1 (baseline), Day 4, Day 7 and Day 14
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the patients:
- •Any woman or man requesting a home visit and having symptoms characteristic of viral infection, with initial manifestation within the previous 48-72 hrs. Such symptoms may include sudden fever onset, accompanied by one or more of the following symptoms: dry cough, sore throat, nasal congestion, headache, musculoskeletal pain, perspiration, fatigue, malaise, blurry vision, loss of the sense of smell.
- •For the people cohabiting with patients:
- •Any woman or man cohabiting with study patients.
排除标准
- •Children and adolescents under the age of 18 years;
- •Pregnant women;
- •Persons suffering from a pre-existing condition preventing them from autonomously providing informed consent.
结局指标
主要结局
Number of patients with symptom resolution
时间窗: 2 weeks (14 days)
Number of patients with symptoms recorded at baseline resolving at 2 weeks (14 days) or sooner
Number of people cohabiting with a patient not developing VRI symptoms
时间窗: 2 weeks (14 days) )
Number of people cohabiting with a patient who did not develop VRI symptoms (per patient) at 2 weeks (14 days)
次要结局
- Intensity of symptoms(2 weeks (14 days))
- Median time to full symptom resolution(2 weeks (14 days))
- Duration of symptoms(2 weeks (14 days))
- Number of patients whose symptoms never exceeded a score of 3-4 (mild)(2 weeks (14 days))
- Quality of life (QoL) of patients(2 weeks (14 days))
研究者
Christor Lionis
Professor of General Practice and Primary Healthcare, Director of the Clinic of Social and Family Medicine
University of Crete