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

NCT05446961 | Completed Phase 2 DMC

• 1 other identifier: 01/2021
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

  1,7,14 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

  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

Study Arms (4)

covid 19 LCLT supplement

ACTIVE COMPARATOR

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

covid 19 placebo

PLACEBO COMPARATOR

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

Healthy LCLT supplement

ACTIVE COMPARATOR

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

Healthy Placebo

PLACEBO COMPARATOR

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

LCLT : 68% elemental L-carnitine and 32 % Tartric acid DIETARY_SUPPLEMENT

3 g orally capsules

Also known as: Carnipure™ Tartrate (LCLT) formulation

Healthy LCLT supplement; covid 19 LCLT supplement

Placebo DRUG

orally capsules

Healthy Placebo; covid 19 placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• SENAI CIMATEC: lead
• Hospital Espanhol: collaborator

Study Sites (1)

Senai Cimatec

Salvador, Estado de Bahia, 41650-010, Brazil

Location

Related Publications (9)

• 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.

  PMID: 31978945 BACKGROUND

• 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.

  PMID: 32142651 BACKGROUND

• 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.

  PMID: 13825279 BACKGROUND

• 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.

  PMID: 7614519 BACKGROUND

• 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.

  PMID: 18607224 BACKGROUND

• 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.

  PMID: 26998047 BACKGROUND

• 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.

  PMID: 32240634 RESULT

• 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.

  PMID: 15141377 RESULT

• 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.

  PMID: 32391299 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Carnitine; Dosage Forms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Roberto Badaró, Ph.D

  SENAI CIMATEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: July 7, 2022
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: February 3, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)