A randomized, double-blind, clinical study to evaluate the effect of CL20189 and CL20193 in mild to moderate COVID-19 subjects

CLS Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Male and female subjects (from OPD/ Hospital Isolation /Quarantine ward) aged between 20-60 years with body mass index (BMI) of 22-29.9 kg/m2. Subjects confirmed as positive for Laboratory (RT-PCR) SARS-CoV-2.
•Subjects with symptoms of mild illness with COVID-19 that include any of the following symptoms: fever, sore throat, cough, malaise, headache, muscle pain, gastrointestinal symptoms.
•Subjects with symptoms of moderate illness with COVID-19 that include mild illness or shortness of breath with exertion or any of the following clinical signs;
•Heart rate/Pulse rate: Ã¢â?°Â¥ 90 beats/min
•Respiratory rate Ã¢â?°Â¥ 20 breaths/min
•Saturation of oxygen (SpO2) > 93% on room air
•Subjects willing to refrain from special diets, probiotics, taking nutritional supplements or medications known to affect immune function or absorption of nutrients during the study period.
•Female subjects have a negative pregnancy test at the screening visit.
•Ability to understand the risks/benefits of the protocol and willing to sign the informed e-consent.

•Subjects with severe or critical COVID-19 condition as per chest CT scan.
•Subjects allergic to any of the study supplement ingredients.
•Subjects with uncontrolled diabetes (RBS >140mg/dL), hypertension (Systolic >145 and Diastolic >90 mmHg).
•Subjects underwent treatment for COVID-19 will be excluded.
•Subjects using Immune modifying medications for last one month, Steroids- for last 03 months).
•Subjects with any history of immune system disorder or auto-immune disorders.
•Subjects with Pneumonia, COPD, asthma, any respiratory or breathing related disorders.
•Subjects who consume alcohol ( >5 drinks per week), habit of smoking, chewing tobacco, use of recreational drugs (such as cocaine, methamphetamine, marijuana etc.).
•Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
•Subjects with HIV Positive.
•Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
•Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
•Any other condition that, in the opinion of the investigator, would adversely affect the subjectÃ¢â?¬•s ability to complete the study or its measures.
•Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening.

发起方

CLS Pvt Ltd