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

What Was Tested

The trial (phase 2) is built around L-Carnitine.

It had four arms (groups): covid 19 LCLT supplement (active comparator), covid 19 placebo (placebo comparator), Healthy LCLT supplement (active comparator) and Healthy Placebo (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 224 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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. Males and females between 18 years and 85 years of age;. Female subjects of childbearing potential must :.

The full record lists 13 inclusion and 8 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

Design: randomized, factorial and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-03-01 with completion listed for 2021-09-01.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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 (time frame: 21 days).

It also tracked 13 secondary outcomes, for example Levels of C-Reactive Protein (CRP) from baseline to 7, 14 and 21 days, Total white blood count (1000 per mm³) from baseline to 7, 14 and 21 days, Levels of plasma ACE1 and ACE2 receptors from baseline to 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, TMPRSS2 and furin gene expression levels from baseline to 21 days placebo in each cohort and Levels of D-Dimer (µg/mL) from baseline to 7, 14 and 21 days.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 224 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.