CTRI/2021/12/038672已完成3 期
A randomized, prospective, double-blind, 3-arm comparative efficacy and safety assessment of the immunoprotective and anti-viral effects of Lactocetin (Lc), a solid form Lactoferrin (Lf) plus Quercetin (Qc) formulation as a supplement to standard treatment in mild and moderate COVID-19 (SARS-CoV-2) subjects
Arna Immuno Ingredients Pvt Ltd AIP0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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.Age: 18-60 years
- •2.Gender: Both (Male and Female)
- •3.Should be classifiable into the ICMR criteria of mild-moderate COVID- 19 category. [Subjects with clinical signs of fever, cough, dyspnea, fast breathing with respiratory rate <30/min, no signs of severe pneumonia, including SpO2 ââ?°Â¥90% on room air without evidence of viral pneumonia or hypoxia]
- •4.Symptomatic subjects with RT-PCR/laboratory-confirmed COVID-19 cases (not more than 3 days prior to study entry, Ct value <35 cycles)
- •5.For subjects with a history of lung fibrosis, COPD, Smokers, long- standing asthmatics: CT-Scan does not indicate any observations of severe/critical COVID-19 condition
- •6.Currently not requiring hospitalization (i.e. Out-patients / Home quarantine / COVID-Care facility only)
- •7.Willing to undertake home quarantine/COVID-care centre for the 3 (three) weeks of the study and 2 (two) weeks of post-therapy follow-up
- •8.Willing to get hospitalized if worsening of COVID-19 to severe or critical occurs, on the advice of the treating physician and/or the medical monitor of the study (based on the current ICMR criteria4)
- •9.Agrees to provide a written or electronic copy of the signed informed consent form (ICF)
- •10.Agrees to follow all requirements of COVID-19 safety protocols, compliance and to any nutritional restrictions and dosing regimen (including home quarantine/hospital admission, blood for lab analysis for a minimum of 4-8 times, and complete the subject diary (temp, symptoms, signs, drug dosages and other parameters daily)
- •11.Has an Aadhar ID or equivalent ID proof, smartphone/mobile connectivity and is willing to receive calls and messages at least once a day by community outreach activities, such as home visits or by remote connect telemedicine by health care workers assigned to this project and authorized by this investigator.
- •12.Individuals who agree not to take any additional medications or other antibiotics during the study period (5-weeks from entry) other than that prescribed as part of Standard Therapy by the physician-in-charge of the study
- •13.Agrees not to self-medicate or take any other therapies during the study and has not been on any such medications, like ivermectin, hydroxychloroquine, dexamethasone, methylprednisolone, budeso-nide (other steroids) or other ayurvedic, homoeopathic, Siddha, or other forms of medications for the past 1 (one) week and agrees to not use during the study period over and above the standard care of therapy that is prescribed
排除标准
- •1.Individuals who will not give written consent (wet-ink/electronic)
- •2.Classification of patientââ?¬•s symptoms are worse (severe, critical), or needing oxygen/ventilator support [Oxygen saturation <90% on room air, Respiratory rate >30 breaths/min, Signs of severe respiratory distress and/or pneumonia]
- •3.Asymptomatic individuals or COVID-19 RT-PCR negative (Ct value ââ?°Â¥35 cycles)
- •4.Known history of allergy or contraindications for Lf/Lc components
- •5.Pregnant/Lactating women
- •6.Individuals who do not agree to not receive or not take any additional medications or other antibiotics during the study period (5-weeks from entry) other than that prescribed as part of Standard Care Therapy by the physician-in-charge of the study
- •7.Individuals on any other medications or nutritional supplements that may influence Lf/Lc evaluations
- •8.Individuals not willing to follow protocol specified diet/nutrition guidelines
- •9.Known cases of uncontrolled Diabetes and Hypertension or other serious co-morbid conditions
- •10.Subjects with a history of severe asthma, interstitial lung disease, or chronic pneumonitis unrelated to COVID-19
- •11.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening for this study
- •12.History of renal failure or dialysis, hypercalcemia, severe liver disease (cirrhosis), sarcoidosis, or other granulomatous diseases (Wegener)
- •13.Previously diagnosed cases of immune-compromised status like HIV, Hepatitis B/C, Tuberculosis, Cancer, etc. or deranged liver or kidney tests
- •14.Subjects taking or need to take systemic/oral steroid treatment and or any kind of immunosuppressive therapy in the pre-study within the last 30 days and during the study period
- •15.Subjects participating in any other clinical study or having participated in any other study <1 month prior to screening in the present study
- •16.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his participation in, and completion of the protocol or their evaluation for protocol parameters
研究者
相似试验
已完成
不适用
A clinical study to evaluate the Efficacy and Safety of Garlixir TM capsules (250 mg or 500 mg) in Hyperlipidemia patientsCTRI/2016/09/007273Biogen Extracts Pvt Ltd78
已完成
不适用
Compare the Efficacy and Safety of Mupirocin Cream USP, 2% in patients with Secondarily Infected Traumatic Skin LesionsCTRI/2020/08/027198Ms Cadila Healthcare Limited956
进行中（未招募）
1 期
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisendometriosis in reproductive-ageMedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2018-002367-26-HUitaphar Laboratorios490
进行中（未招募）
1 期
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisendometriosis in reproductive-ageMedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2018-002367-26-BGitaphar Laboratorios220
进行中（未招募）
1 期
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisEUCTR2018-002367-26-PLitaphar Laboratorios490