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Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT05446961•SENAI CIMATEC

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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;
+3 more 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).

Locations (1)

Senai Cimatec

Salvador, Estado de Bahia, Brazil

Key Dates

Start Date

March 1, 2021

Primary Completion Date

September 1, 2021

Completion Date

February 3, 2022

Last Updated

July 7, 2022

Enrollment

224

ACTUAL participants

Conditions

COVID-19 Virus Infection

Interventions

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

DIETARY_SUPPLEMENT

Placebo

DRUG

Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)

NCT04560881

COVID-19 Virus Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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