Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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)

Conditions
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COVID-19 Virus Infection

Intervention / Treatment
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* Dietary Supplement: LCLT : 68% elemental L-carnitine and 32 % Tartric acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort 1: 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. Cohort 2: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: A total of 274 subjects, will be prospectively enrolled into a pilot randomized, placebo controlled study in the two cohorts: Cohort 1: 220 healthy, SARS-CoV-2 negative, individuals (55 to 85 years old) with close contact (cohabit) to a person with newly acquired SARS-CoV-2 infection based on PCR detection and absence of antibody response; and, Cohort 2: 54 asymptomatic ( 18 to 85 years old) or symptomatic patients with mild COVID-19 that tested positive for COVID-19 by RT-PCR within the last 24 hours prior to the enrolment in the study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: covid 19 LCLT supplement<br>LCLT is made out of 68% elemental L-carnitine and 32 % Tartric acid and therefore the EFSA (European Food Safety Authority) stated that it is safety up to at least 3 g. Each 3 g of LCLT delivers 2 g of elemental L-carnitine L-carnitine and Tartric acid, 3g oral capsules daily use for 21 days | Dietary Supplement: LCLT : 68% elemental L-carnitine and 32 % Tartric acid<br>* 3 g orally capsules<br>* Other names: Carnipure™ Tartrate (LCLT) formulation;|
| Placebo Comparator: covid 19 placebo<br>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 | Drug: Placebo<br>* orally capsules<br>|
| Active Comparator: Healthy LCLT supplement<br>LCLT is made out of 68% elemental L-carnitine and 32 % Tartric acid and therefore the EFSA (European Food Safety Authority) stated that it is safety up to at least 3 g. Each 3 g of LCLT delivers 2 g of elemental L-carnitine L-carnitine and Tartric acid, 3g oral capsules daily use for 21 days | Dietary Supplement: LCLT : 68% elemental L-carnitine and 32 % Tartric acid<br>* 3 g orally capsules<br>* Other names: Carnipure™ Tartrate (LCLT) formulation;|
| Placebo Comparator: Healthy Placebo<br>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 | Drug: Placebo<br>* orally capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR | Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR | 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 | 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 | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of C-Reactive Protein (CRP) from baseline to 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 | 
| Total white blood count (1000 per mm³) from baseline to 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 plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days | Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days | 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 | 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 | 
| ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort | ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days | 1 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 | 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 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 | 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 | Levels of 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 | Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days | 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 | Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days | 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 | Levels of fibrinogen (g/L) 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 | Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days | 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 | Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days | 1,7,14 and 21 days |