NCT05446961

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: SENAI CIMATEC · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Virus Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	LCLT : 68% elemental L-carnitine and 32 % Tartric acid	3 g orally capsules
DRUG	Placebo	orally capsules

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-09-01
• Completion: 2022-02-03
• First posted: 2022-07-07
• Last updated: 2022-07-07

Locations

1 site across 1 country: Brazil