Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT05226767
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19
Sponsor:
Todos Medical, Ltd.
Organization:
Study Overview
Official Title:
A Phase II, Randomized, Double-blind, Placebo Controlled Clinical Study Designed to Evaluate the Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19.
Detailed Description:
Herbal remedies and purified natural products provide a rich resource for the development of new antiviral drugs. The detection of antiviral mechanisms in these natural substances sheds light on where they interact with the viral life cycle, such as penetration, replication, assembly and release of the virus, as well as on tuning to specific host-virus interactions. CoV is a virus that belongs to the corona virus family. The CoV virus family causes infections in the upper respiratory tract and gastrointestinal tract in mammals and birds. In humans, it mainly causes colds, but complications can also occur, such as pneumonia and severe acute respiratory syndrome. Corona virus with the known acute respiratory syndrome caused a global threat with high mortality in 2003, and again in 2019 and 2020.
The plant family of lithosperm, have been used in traditional Chinese medicine for the treatment of external wounds, burns or dermatitis for centuries. Studies conducted over the past 30 years have shown that there is a scientific basis and pharmacological properties. The active ingredients that were successfully extracted from the plant were found to be strong inhibitors of the enzyme family found in corona virus polypropylene 3C. Aim of the study: This study was designed to evaluate the efficacy of NLC-V in patients diagnosed with COVID-19.
Details of the research and clinical follow-up phases: A total of 66 adult patients with a certified diagnosis of SARS-CoV-2 virus infection, who are hospitalized due to the infection, will be recruited. NLC-V study therapy is given in oral capsules. Each NLC-V capsule contains 100 mg of active ingredients in a special formulation. Patients will be randomly assigned a 1: 1 ratio to receive NLC-V or placebo, which are additionally given.
The plant family of lithosperm, have been used in traditional Chinese medicine for the treatment of external wounds, burns or dermatitis for centuries. Studies conducted over the past 30 years have shown that there is a scientific basis and pharmacological properties. The active ingredients that were successfully extracted from the plant were found to be strong inhibitors of the enzyme family found in corona virus polypropylene 3C. Aim of the study: This study was designed to evaluate the efficacy of NLC-V in patients diagnosed with COVID-19.
Details of the research and clinical follow-up phases: A total of 66 adult patients with a certified diagnosis of SARS-CoV-2 virus infection, who are hospitalized due to the infection, will be recruited. NLC-V study therapy is given in oral capsules. Each NLC-V capsule contains 100 mg of active ingredients in a special formulation. Patients will be randomly assigned a 1: 1 ratio to receive NLC-V or placebo, which are additionally given.
Study Oversight
Has Oversight DMC:
False
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?: