Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus, SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- 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).
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Exclusion Criteria:
- 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.
Sites / Locations
- Shaare Zedek Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active Arm
Placebo
Patients who receive treatment with the NLC-V research product depending on the weight of the patients, as follows - Patients weighing less than 70 kg will receive 2 capsules, 4 times a day (80 mg in total per day) Patients weighing between 70 kg and 100 Kg will receive 3 capsules, 4 times a day (a total of 120 mg per day). Patients weighing over 100 kg will receive 4 capsules, 4 times a day (a total of 160 mg per day). NLC-V capsules Will be taken during days 1-10 for the patient's hospitalization NLC-V capsules will be taken during days 1-10 for the patient's hospitalization
Patients who receive placebo in addition to the usual treatment for COVID-19. The placebo consists of the same solvent, but without the active ingredients of NLC-V. Placebo will be given to patients in the same manner and with the same frequency as NLC-V