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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
3 g orally capsules
orally capsules
Senai Cimatec
Salvador, Estado de Bahia, Brazil
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
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
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
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
Time frame: 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
Time frame: 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
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
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, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort
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ACE1, ACE2, TMPRSS2 and furin gene expression levels from baseline to 21 days
Time frame: 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
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
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 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1,7,14 and 21 days