CompletedNCT05446961Updated Jul 7, 2022

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

A Phase 2 interventional study of LCLT : 68% elemental L-carnitine and 32 % Tartric acid and Placebo in COVID-19 Virus Infection, sponsored by SENAI CIMATEC. Completed at 1 site in Brazil. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-07.

Sponsored by SENAI CIMATEC · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Mar 2021, registered Apr 2022).

Phase: Phase 2
Study type: Interventional
Enrollment: 224
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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

Read the 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.

Conditions studied

COVID-19 Virus Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 224 is above the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

SENAI CIMATEC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 224 participants (actual)

Study arms

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
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
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
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

Interventions

Dietary supplementLCLT : 68% elemental L-carnitine and 32 % Tartric acid
3 g orally capsules
Also known as: Carnipure™ Tartrate (LCLT) formulation
DrugPlacebo
orally capsules

What researchers measure

Primary outcomes

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

Secondary outcomes

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
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

Study locations

1 site

Senai Cimatec
Salvador, Bahia 41650-010, Brazil

References and documents

Publications

Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. PubMed 31978945 ↗
Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5. PubMed 32142651 ↗
FRITZ IB. Action of carnitine on long chain fatty acid oxidation by liver. Am J Physiol. 1959 Aug;197:297-304. doi: 10.1152/ajplegacy.1959.197.2.297. No abstract available. PubMed 13825279 ↗
Brass EP. Pharmacokinetic considerations for the therapeutic use of carnitine in hemodialysis patients. Clin Ther. 1995 Mar-Apr;17(2):176-85; discussion 175. doi: 10.1016/0149-2918(95)80017-4. PubMed 7614519 ↗
Kraemer WJ, Volek JS, Dunn-Lewis C. L-carnitine supplementation: influence upon physiological function. Curr Sports Med Rep. 2008 Jul-Aug;7(4):218-23. doi: 10.1249/JSR.0b013e318180735c. PubMed 18607224 ↗
Ozturk MA, Kardas Z, Kardas F, Gunes T, Kurtoglu S. Effects of L-carnitine supplementation on respiratory distress syndrome development and prognosis in premature infants: A single blind randomized controlled trial. Exp Ther Med. 2016 Mar;11(3):1123-1127. doi: 10.3892/etm.2015.2964. Epub 2015 Dec 29. PubMed 26998047 ↗
Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunuba Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30. Erratum In: Lancet Infect Dis. 2020 Jun;20(6):e116. doi: 10.1016/S1473-3099(20)30309-1. Lancet Infect Dis. 2020 Jun;20(6):e116. doi: 10.1016/S1473-3099(20)30368-6. PubMed 32240634 ↗
Hamming I, Timens W, Bulthuis ML, Lely AT, Navis G, van Goor H. Tissue distribution of ACE2 protein, the functional receptor for SARS coronavirus. A first step in understanding SARS pathogenesis. J Pathol. 2004 Jun;203(2):631-7. doi: 10.1002/path.1570. PubMed 15141377 ↗
Ciaglia E, Vecchione C, Puca AA. COVID-19 Infection and Circulating ACE2 Levels: Protective Role in Women and Children. Front Pediatr. 2020 Apr 23;8:206. doi: 10.3389/fped.2020.00206. eCollection 2020. No abstract available. PubMed 32391299 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05446961
Lead sponsor: SENAI CIMATEC
Collaborators: Hospital Espanhol
Responsible party: Sponsor
First posted: Jul 7, 2022
Start date: Mar 1, 2021
Primary completion: Sep 1, 2021
Completion: Feb 3, 2022
Last update: Jul 7, 2022

Study contacts

Roberto Badaró, Ph.D

principal investigator · SENAI CIMATEC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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