An Open Label, Multicenter, Randomized, Controlled, Clinical Study to Evaluate the Efficacy and Safety of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets Compared With Standard Treatment Protocol in the Treatment of Mild to Moderate COVID-19 Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Time (Days) to clinical improvement from study enrollment
研究概览
简要总结
While novel drug discovery and vaccine studies are time taking process, re-purposing old drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical, pharmacokinetic, pharmacodynamic, and toxicity profiles, which can rapidly enter Phase 3 or 4 or can be used directly in clinical settings. Immunofree has many of the herbs which have been evaluated by other trials published for Covid-19 treatment.
The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a combination of polyherbal mixture. The components of this formulation are known for their anti-viral and immunomodulatory effects. Also, Reginmune, owing to its immunomodulatory effect might help in easing the symptoms and decrease the viral load.
详细描述
The symptoms of COVID-19 are mainly for respiratory disorders and similar to severe acute respiratory symptoms. The common signs of infection observed in COVID-19 patients include respiratory symptoms, sneezing, fever, cough, shortness of breath and other breathing difficulties. In case of severely infected patients, infection can cause pneumonia, severe acute respiratory syndrome (SARS), kidney failure and even death in many cases. There are many people who had high viral load but do not develop COVID-19 symptoms like coughing or sneezing. Such asymptomatic people serve as hidden carriers of virus and may further contribute in enhanced transmission of virus to other people. In absence of any emergency medicine or complete therapy for COVID-19; the prevention of spread of SARS-CoV2 virus and regulation of infection is the prime step in controlling this epidemic disease, in which the test products can be of immense value.
The test product, Capsule Reginmune is a combination of some phytochemicals, amino acids, vitamins and minerals and a bio-polymer in cellular matrix. The components and their pharmacological activities are as follow:
Echinacea is one of the more popular herbal supplements suggested for boosting immunity. Some respiratory and antiviral research has also been done on Echinacea. Echinacea is not mentioned by the Indian and Chinese Governments however in their guidelines for boosting immunity.
Cats Claw (Uncaria Tomentosa)has shown potent anti-viral and immunomodulatory activity in a recent study. The results demonstrated an in vitro inhibitory activity by both extract and alkaloidal fraction, reducing DENV-Ag+ cell rates in treated monocytes. A multiple microbead immunoassay was applied for cytokine determination (TNF-alpha, IFN-alpha, IL-6 and IL-10) in infected monocyte culture supernatants. The alkaloidal fraction induced a strong immunomodulation: TNF-alpha and IFN-alpha levels were significantly decreased and there was a tendency towards IL-10 modulation. The researchers conclude that the alkaloidal fraction was the most effective in reducing monocyte infection rates and cytokine levels. The antiviral and immunomodulating in vitro effects from U. tomentosa pentacyclic oxindole alkaloids displayed novel properties regarding therapeutic procedures in Dengue Fever and might be further investigated as a promising candidate for clinical application.
Vitamin C: Well accepted to increase immunity and an effective antiviral. However, not many people realize the vast difference in food derived vitamin C and ascorbic acid which is a dead synthesized molecule used to clean pools. Therefore, it is strongly recommended that one should only take food derived Vitamin C.
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
- None
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
- 否
入选标准
- •Gender: Either male or non-pregnant, non-lactating female aged > 18-70
- •Patients with RT-PCR confirmed diagnosis of COVID-19
- •Patients with mild to moderate COVID-19 infection having either one of the following criteria: oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 > 90% on room air
- •Subjects willing to give written informed consent
- •Subjects able to take the drug orally and comply with the study protocol
- •Women of child bearing potential must have a negative urine pregnancy test prior to study entry
排除标准
- •Patients with persistent vomiting
- •Critically ill patients
- •P/F ratio less than 200 (moderate-severe ARDS)
- •Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)
- •Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections
- •Patients with altered mental state
- •Patients with multiple organ failure requiring ICU monitoring and treatment
- •Patients with respiratory failure and requiring mechanical ventilation
- •Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subject's participation in the study or interferes with the interpretation of the study results.
- •Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
- •Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission
- •Patient who have participated in another investigational study within 3 months prior to enrollment in this study
- •Investigators, study personnel, sponsor's representatives and their first-degree relatives.
- •Pregnant subjects
结局指标
主要结局
Time (Days) to clinical improvement from study enrollment
时间窗: Day 0 - Day 10
This includes overall time it takes for negative covid-19 results, improvement based on a customized questionnaire for fever, cough, body ache, loss of taste or smell, or other similar conditions
次要结局
- Time to first negative SARS-CoV-2 PCR in NP swab(Day 0, Day 5±1 and Day of discharge i.e Day 10±1)
- Value of coagulation indicators(Day 0, Day 5±1 and Day of discharge i.e Day 10±1)
- Duration of oxygen therapy(upto day 10+1)
- Duration of hospitalization(upto day 10+1)
- Proportion of participants in each group with oxygen saturation more than 94% on room air for more than 24h(Day 0, Day 5±1 and Day of discharge i.e Day 10±1)
- Proportion of participants in each group with need for mechanical ventilation(upto day 10+1)
研究者
PUNEET MITTAL
Clinical Research Consultant
Nutrin GmbH