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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05446961
Recruitment Status : Completed
First Posted : July 7, 2022
Last Update Posted : July 7, 2022
Sponsor:
Collaborator:
Hospital Espanhol
Information provided by (Responsible Party):
SENAI CIMATEC

Brief Summary:
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

Condition or disease Intervention/treatment Phase
COVID-19 Virus Infection Dietary Supplement: LCLT : 68% elemental L-carnitine and 32 % Tartric acid Drug: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : February 3, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: covid 19 LCLT supplement
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
3 g orally capsules
Other Name: Carnipure™ Tartrate (LCLT) formulation

Placebo Comparator: 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
Drug: Placebo
orally capsules

Active Comparator: Healthy LCLT supplement
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
3 g orally capsules
Other Name: Carnipure™ Tartrate (LCLT) formulation

Placebo Comparator: 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
Drug: Placebo
orally capsules




Primary Outcome Measures :
  1. Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR [ Time Frame: 21 days ]
    Number new SARS-CoV-2 cases at 21 days assessed by RT-PCR

  2. 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 [ Time Frame: 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


Secondary Outcome Measures :
  1. Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days [ Time Frame: 1,7,14 and 21 days ]
    Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days

  2. Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days [ Time Frame: 1,7,14 and 21 days ]
    Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days

  3. Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days [ Time Frame: 1, 7, 14 and 21 days ]
    Levels of plasma ACE1 and ACE2 receptors from baseline to 7, 14 and 21 days

  4. ACE1/ACE2 ratio from baseline to 7, 14 and 21 days days until the end of the study of each cohort [ Time Frame: 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

  5. ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort [ Time Frame: 1 and 21 days ]
    ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days

  6. 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 [ Time Frame: 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

  7. 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 [ Time Frame: 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

  8. 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 [ Time Frame: 1,7,14 and 21 days ]
    Levels of total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days

  9. 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 [ Time Frame: 1,7,14 and 21 days ]
    Levels of hemoglobin count (g/dl) from baseline to 7, 14 and 21 days

  10. 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 [ Time Frame: 1,7,14 and 21 days ]
    Total platelets count (1000 per mm³) from baseline to 7, 14 and 21 days

  11. 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 [ Time Frame: 1,7,14 and 21 days ]
    Levels of fibrinogen (g/L) from baseline to 7, 14 and 21 days

  12. Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days [ Time Frame: 1,7,14 and 21 days ]
    Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days

  13. 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 [ Time Frame: 1,7,14 and 21 days ]
    Levels of Ferritin (µg/mL) from baseline to 7, 14 and 21 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05446961


Locations
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Brazil
Senai Cimatec
Salvador, Bahia, Brazil, 41650-010
Sponsors and Collaborators
SENAI CIMATEC
Hospital Espanhol
Investigators
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Principal Investigator: Roberto Badaró, Ph.D SENAI CIMATEC
Publications of Results:
Other Publications:

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Responsible Party: SENAI CIMATEC
ClinicalTrials.gov Identifier: NCT05446961    
Other Study ID Numbers: 01/2021
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Virus Diseases
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases