COVID-19 Clinical Trial
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
Verified date | February 2022 |
Source | Todos Medical, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19.
Status | Completed |
Enrollment | 31 |
Est. completion date | January 20, 2022 |
Est. primary completion date | November 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Men and Women aged 18 (inclusive) and above. 2. Confirmed SARS-CoV-2 infection by RT-PCR If confirmed >5 days before the randomization, another test will be taken on day 1. 3. Hospitalized COVID-19 patient in stable moderate condition to upper scale of severe condition (i.e., not requiring full respiratory assessment). 4. Oxygenation < 96% on room air. 5. 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 Criteria: 1. Tube feeding or parenteral nutrition. 2. Respiratory decompensation requiring mechanical ventilation. 3. Pregnant or lactating women. 4. 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). 5. Known to have severe allergic reactions to one of the study drug components. 6. Active tuberculosis (TB) infection. 7. Subjects diagnosed to suffer from concomitant active infection: bacterial, fungal, viral, or other infection cause besides COVID-19. 8. 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. 9. Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months (steroids are permitted). 10. Participating in other drug clinical trial. 11. Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration). 12. 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). 13. Absolute neutrophil count (ANC) < 1000/uL at screening. 14. Platelet count < 50,000/uL at screening. 15. Body weight < 40 kg or >120 kg. 16. Treatment with other investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization. |
Country | Name | City | State |
---|---|---|---|
Israel | Shaare Zedek Hospital | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Todos Medical, Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time relapsed from hospitalization (1st day) until hospital discharge in patients receiving NLC-V treatment. | Time relapsed from hospitalization (1st day) until hospital discharge in patients receiving NLC-V treatment. | ||
Primary | 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 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. | ||
Secondary | Rate of change of measured parameters. | Time relapsed from hospitalization (1st day) until hospital discharge | ||
Secondary | Rate of change in vital signs (blood pressure, heart rate, respiratory rate, saturation, body temperature). | Time relapsed from hospitalization (1st day) until hospital discharge | ||
Secondary | Time from the 1st day of receiving NLC-V treatment to negative test result by RT-PCR for COVID-19. | Time relapsed from hospitalization (1st day) until hospital discharge | ||
Secondary | COVID-19 - related death in the treatment group (NLC-V) compared to the control group. | Time relapsed from hospitalization (1st day) until hospital discharge | ||
Secondary | Incidence of deterioration and need to mechanical ventilation in both treatment group (NLC-V) and control group. | Time relapsed from hospitalization (1st day) until hospital discharge | ||
Secondary | Incidence and duration of time on supplemental oxygen in both treatment group (NLC-V) and control group. | Time relapsed from hospitalization (1st day) until hospital discharge | ||
Secondary | Sensitivity and specificity of NLC's COVID-19 diagnostic test | Time relapsed from hospitalization (1st day) until hospital discharge |
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