A clinical study to evaluate the role of Herbal Immunomodulator (VIRANORM) as an add on treatment in Asymptomatic and mildly symptomatic covid-19 confirmed cases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Difference in disease manifestation in asymptomatic patients
研究概览
简要总结
VIRANORM - Proprietary Ayurvedic Medicine. Manufacturing License No. A-1408/86
The current pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 3-4%. Very few anti-viral agents have shown minimal efficacy which is insufficient to decrease the severity of the pandemic spread of COVID-19.
The aim of this randomized controlled trial is to assess the effect of VIRANORM, an Ayurvedic proprietary medicine on the development of symptoms in asymptomatic patients or duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger community based clinical studies on the clinical efficacy of VIRANORM in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for the reduction of community transmission.
Natural products and their derivatives are used in folk medicine to treat numerous ailments including viral infections. Herbal preparations owing to their holistic approach strengthen the body’s immune system, which in turn may help the body fight against invading infectious viruses.
VIRANORM Ingredients
Zingiber officinale
Cissus quadrangularis
Allium sativa
Tinospora cordifolia
Withania somnifera
Andrographis paniculata
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Must be ≥18 years and ≤70 years at the time of signing the informed consent
- •Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures
- •Able to adhere to the study visit schedule and other protocol requirements
- •Asymptomatic or Mild Symptomatic PCR positive COVID-19 infection with outpatient/in-patient management as decided by the treating physician
- •Early warning score for 2019-nCoV infected patients < 5
- •Females of childbearing potential must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
- •Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met.
排除标准
- •Requirement for oxygen administration
- •Shortness of breath in resting position
- •Creatinine > 2.0 mg/dl
- •Concomitant bacterial respiratory infection documented by respiratory culture.
- •NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
- •Women during pregnancy and lactation
- •Participation in other clinical trials or observation period of competing trials
- •Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
- •Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
- •Physician decision that involvement in the study is not in the patient´s best interest
- •History of alcohol or drug abuse in the previous two years.
结局指标
主要结局
Difference in disease manifestation in asymptomatic patients
时间窗: Enrolment | Day 3 | Day 7 | Day 14 | Day 21
Difference in time to resolution of clinical signs and symptoms of mild COVID-19
时间窗: Enrolment | Day 3 | Day 7 | Day 14 | Day 21
Proportion of patients with negative COVID-19 PCR test at day 21 in per protocol population
时间窗: Enrolment | Day 3 | Day 7 | Day 14 | Day 21
Difference between VIRANORM - and placebo treated patients on an ordinal outcome scale until Day 21 (death, admission to intensive care, hospitalization, duration of hospitalization, continuing disease, recovered)
时间窗: Enrolment | Day 3 | Day 7 | Day 14 | Day 21
次要结局
- COVID-19 antibodies and clinical immunological markers(Day 14)