CTRI/2021/07/034611Other不适用
Single-center, double blinded, two arm placebo controlled clinical study to assess the safety and efficacy of XAR-XAP nutraceutical formulation in COVID-19 patients
试验速览
- 阶段
- 不适用
- 状态
- Other
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To investigate the clinical efficacy of XAR-XAP treatment in reducing the duration and severity of illness compared to placebo
研究概览
简要总结
The clinical study will have a total of 28 subjects; divided into 2 groups having 14 subjects each, wherein group 1 would receive the placebo, group 2 would receive XAR-XAP. The study would be carried out in Maharashtra itself and would go on for a period of 90 days, wherein the treatment would be given for 30 days along with the standard of care, and for the remaining 60 days we would monitor the antibody levels in the patients. Patients diagnosed with recent mild to moderate COVID infection requiring isolation or home quarantine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature ≥ 38 ℃ (100.4 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate ≥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats).
- •If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
- •Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit
- •The onset of symptoms is defined as either: 3a.
- •Time of the first increase in body temperature to ≥ 38 ℃ (100.4 °F); or 3b.
- •Time when the subject experiences at least one general or respiratory symptom.
- •Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses).
- •Subjects who are able to understand and willing to sign the informed consent form (ICF).
- •Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures.
- •All female subjects of child-bearing potential must have a negative urine pregnancy test result.
- •All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.
排除标准
- •Severe COVID-19 infection.
- •History of Chronic Exposure to Smoking
- •other concurrent infections requiring systemic antiviral therapy prior to screening.
- •Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, and antiviral drugs during the previous 4 weeks before the first dose.
- •Use of corticosteroids as part of the current standard of care is permitted.
- •Allergy or known allergy to components of study medication (Peanuts and Mushroom).
- •Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.
结局指标
主要结局
To investigate the clinical efficacy of XAR-XAP treatment in reducing the duration and severity of illness compared to placebo
时间窗: Day 0, Day 15, Day 30, Day 60, Day 90
次要结局
- To investigate the effect of XAR-XAP treatment on the anti SARS-CoV-2 antibody levels in COVID-19 subjects on Day 0, Day 30, day 60 and day 90(To monitor long term protection (until 90 days) of COVID-19 patients with or without controlled diabetes and hypertension.)
研究者
研究点 (1)
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