Pilot Phase II Randomized, Placebo-Controlled Clinical Trial for the Prevention and Progression of SARS-CoV-2 Infection of Subjects and Patients Using a Supplement Treatment With Carnipure Tartrate ( LCLT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
研究概览
简要总结
The purpose of the study is to assess safety and efficacy of Carnipure tartrate (L-Carnitine and L-tartaric acid - LCLT) supplementation for SARS-Cov-2 infection
详细描述
After being informed about the study and potential risks, all patients given written informed consent will be divided em two cohorts according to inclusion criteria.One group with patients with diagnosed mild SARS-Cov-2 infection and another with healthy contacts of patients with diagnosed mild SARS-Cov-2.
Both groups will be randomized to receive either LCLT supplementation or placebo during 21 days. After this period primary endpoints of efficacy will be assessed.
Clinical follow up evaluations will be monitored (Cohort 1 and 2), and chest tomography will be monitored in cohort 2 as well. Subjects will be followed for safety through 8 weeks (cohort 1) and 6 weeks (cohort 2) after being included into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The groups will be randomized and blindly assigned to receive either the LCLT supplement (3 g per day that delivers 2 g elemental of L-carnitine) or placebo. Subjects from Cohort 2 will receive L-carnitine in addition to Standard of Care (SOC) therapy or placebo in addition tosStandard of care (SOC) therapy
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and females between 55 years and 85 years of age;
- •history of close contact (cohabit) with a Family member or a person newly diagnosed with SARS-CoV-2 infection;
- •negative RT-PCR COVID-19 test on the screening immediately after contact and prior to start treatment of the study.
- •males and females between 18 years and 85 years of age;
- •positive RT-PCR COVID-19 test and medical history and physical exam compatible with asymptomatic or mild COVID-19 pneumonia. Evaluation of clinical outcomes: oxygen requirements, hospitalization breathless and others;
- •Female subjects of childbearing potential must :
- •have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study supplementation;
- •no breast-feeding;
- •agree to use one of the following methods of contraception from enrollment in study until 30 days after last supplementation (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy. system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy;
- •Normal laboratory values of sodium, potassium, ALT, AST, total bilirubin, alcaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobina and platelet count;
- •No medical history of alcohol or drug abuse
排除标准
- •Hormonal replacement therapy;
- •Severe COVID-19 pneumonia according to CDC criteria;
- •Positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies;
- •Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Screening;
- •Immunosuppressive cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to Screening;
- •Subjects unable to sign the inform consent to participate into the study;
- •History of any other acute or uncontrolled chronic illness (including, hypertension, cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders) that is not on medication regimen for at least the past 6 months;
- •Medication or supplements that may interfere with the evaluation of the safety and tolerability of the study drug such as ACE Inhibitors, Angiotensin II Receptor Blockers (ARBs) (e.g. vitamin B3 and L-carnitine/acetyl-carnitine).
研究组 & 干预措施
covid 19 placebo
The formulation will contain all salt ingredients v/v without LCLT (made out of 68% elemental L-carnitine and 32 % Tartric acid) and is replaced by Maltodextrin in the placebo capsules Placebo capsules daily for 21 days
干预措施: Placebo (Drug)
Healthy Placebo
The formulation will contain all salt ingredients v/v without LCLT (made out of 68% elemental L-carnitine and 32 % Tartric acid) and is replaced by Maltodextrin in the placebo capsules Placebo capsules daily for 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
时间窗: 21 days
Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR
Number of participants with severe COVID pneumonia measured by the presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography
时间窗: 21 days
Number of participants with severe COVID pneumonia measured by the presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography
次要结局
- Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days(1, 7, 14 and 21 days)
- ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort(1 and 21 days)
- Levels of inflammatory cytokines IL-6, IL-2, IL-7, IL-10,granulocyte-colony stimulating factor (GM-CSF), interferon-γ (IFN-γ) and Tumor Necrosis Factor (TNF-α) from baseline to 7, 14 and 21 days(1,7,14 and 21 days)
- Levels of total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort(1,7,14 and 21 days)
- ACE1/ACE2 ratio from baseline to 7, 14 and 21 days days until the end of the study of each cohort(1, 7, 14 and 21 days)
- Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort(1,7,14 and 21 days)
- Levels of fibrinogen (g/L) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in(1,7,14 and 21 days)
- Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days(1,7,14 and 21 days)
- Presence of presence of ground-glass opacity, consolidations, parenchymal bands, and crazy-paving pattern in chest tomography from baseline to 7, 14 and 21 days(1, 7, 14 and 21 days)
- Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days(1,7,14 and 21 days)
- Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days(1,7,14 and 21 days)
- Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort(1,7,14 and 21 days)
- Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days Days 1, 7, 14 and 21 days after the administration of supplement or placebo in each cohort(1,7,14 and 21 days)