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

SENAI CIMATEC

Status and phase

Completed

Phase 2

Conditions

COVID-19 Virus Infection

Treatments

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

Drug: Placebo

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT05446961

01/2021

Details and patient eligibility

About

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

Full 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.

Enrollment

224 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

224 participants in 4 patient groups, including a placebo group

covid 19 LCLT supplement

Active Comparator group

Description:

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

Treatment:

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

covid 19 placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Healthy LCLT supplement

Active Comparator group

Description:

Treatment:

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

Healthy Placebo

Placebo Comparator group

Description:

Treatment:

Drug: Placebo