CTRI/2021/07/034611Other未知
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
- 未知
- 状态
- Other
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature >= 38 â?? (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.
- •2. 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 1.
- •3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:
- •3a. Time of the first increase in body temperature to >= 38 â?? (100.4 °F); or
- •3b. Time when the subject experiences at least one general or respiratory symptom.
- •4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses).
- •5. Subjects who are able to understand and willing to sign the informed consent form (ICF).
- •6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures.
- •7. 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
- •1. Severe COVID-19 infection.
- •2. History of Chronic Exposure to Smoking
- •3. other concurrent infections requiring systemic antiviral therapy prior to screening.
- •4. 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.
- •6. Allergy or known allergy to components of study medication (Peanuts and Mushroom).
- •7. Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.
研究者
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