This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
NLC-V
Shaare Zedek Hospital
Jerusalem, Israel
Time relapsed from hospitalization (1st day) until hospital discharge in patients receiving NLC-V treatment.
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge in patients receiving NLC-V treatment.
Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 maintained for 24 hours, in the treatment group (NLC-V) compared to the control group.
Time frame: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 maintained for 24 hours, in the treatment group (NLC-V) compared to the control group.
Rate of change of measured parameters.
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge
Rate of change in vital signs (blood pressure, heart rate, respiratory rate, saturation, body temperature).
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge
Time from the 1st day of receiving NLC-V treatment to negative test result by RT-PCR for COVID-19.
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge
COVID-19 - related death in the treatment group (NLC-V) compared to the control group.
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge
Incidence of deterioration and need to mechanical ventilation in both treatment group (NLC-V) and control group.
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge
Incidence and duration of time on supplemental oxygen in both treatment group (NLC-V) and control group.
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Time frame: Time relapsed from hospitalization (1st day) until hospital discharge
Sensitivity and specificity of NLC's COVID-19 diagnostic test
Time frame: Time relapsed from hospitalization (1st day) until hospital discharge