Status:
COMPLETED
Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19
Lead Sponsor:
Todos Medical, Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Men and Women aged 18 (inclusive) and above.
- Confirmed SARS-CoV-2 infection by RT-PCR If confirmed \>5 days before the randomization, another test will be taken on day 1.
- Hospitalized COVID-19 patient in stable moderate condition to upper scale of severe condition (i.e., not requiring full respiratory assessment).
- Oxygenation \< 96% on room air.
- Subjects must be under observation or admitted to a controlled facility or hospital due to lung infection / respiratory infection only (home quarantine is not sufficient).
- \-
Exclusion
- Tube feeding or parenteral nutrition.
- Respiratory decompensation requiring mechanical ventilation.
- Pregnant or lactating women.
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints (for examples social condition other non-related medical illness).
- Known to have severe allergic reactions to one of the study drug components.
- Active tuberculosis (TB) infection.
- Subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides COVID-19.
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24-36 hours, irrespective of the provision of treatments.
- Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted).
- Participating in other drug clinical trial.
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min (including patients receiving hemodialysis or hemofiltration).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges).
- Absolute neutrophil count (ANC) \< 1000/uL at screening.
- Platelet count \< 50,000/uL at screening.
- Body weight \< 40 kg or \>120 kg.
- Treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization.
Key Trial Info
Start Date :
January 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05226767
Start Date
January 30 2021
End Date
January 20 2022
Last Update
February 7 2022
Active Locations (1)
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1
Shaare Zedek Hospital
Jerusalem, Israel