Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-01-13 @ 9:36 AM
Study NCT ID:
NCT05446961
Status:
COMPLETED
Last Update Posted:
2022-07-07
First Post:
2022-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Effect of Food Supplement in People Infected With Coronavirus
Sponsor:
SENAI CIMATEC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: