Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19

NCT05226767 | Completed Phase 2

• 1 other identifier: NLC-V-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19.

Conditions

COVID-19

Keywords

Coronavirus; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• Rate of change of measured parameters.

  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 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 relapsed from hospitalization (1st day) until hospital discharge

• COVID-19 - related death in the treatment group (NLC-V) compared to the control group.

  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 relapsed from hospitalization (1st day) until hospital discharge

Study Arms (2)

Active Arm

ACTIVE COMPARATOR

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

Dietary Supplement: NLC-V

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: NLC-V

Interventions

NLC-V DIETARY_SUPPLEMENT

NLC-V

Active Arm; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Todos Medical, Ltd.: lead

Study Sites (1)

Shaare Zedek Hospital

Jerusalem, Israel

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dorit Arad, PhD

  Todos Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned a 1: 1 ratio to receive NLC-V or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 7, 2022
• Study Start: January 30, 2021
• Primary Completion: November 2, 2021
• Study Completion: January 20, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)