COVID-19Phase 2NCT05226767
Effect of Daily Oral Administration of Food Supplement NLC-V in Patients Diagnosed With COVID-19
A Phase 2 study testing NLC-V in people with COVID-19, run by Todos Medical, Ltd. at 1 site in Israel.
Trial summary
This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- NLC-V
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jan 2021to 20 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is designed to evaluate the safety and efficacy of NLC-V in patients diagnosed with COVID-19.
Read the 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 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.
- Conditions
- COVID-19
- Being tested
- NLC-V
- Keywords
- Coronavirus, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NLC-VDietary supplement
NLC-V
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: NLC-V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time relapsed from hospitalization (1st day) until hospital discharge in patients receiving NLC-V treatment.
Measured: 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.
Measured: 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.
Measured: Time relapsed from hospitalization (1st day) until hospital discharge
Rate of change in vital signs (blood pressure, heart rate, respiratory rate, saturation, body temperature).
Measured: 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.
Measured: Time relapsed from hospitalization (1st day) until hospital discharge
COVID-19 - related death in the treatment group (NLC-V) compared to the control group.
Measured: 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.
Measured: 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.
Measured: Time relapsed from hospitalization (1st day) until hospital discharge
Sensitivity and specificity of NLC's COVID-19 diagnostic test
Measured: Time relapsed from hospitalization (1st day) until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start30 Jan 2021
- Primary completion2 Nov 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Todos Medical, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dorit Arad, PhD, Study chair, Todos Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226767
- Sponsor's protocol ID
- NLC-V-01
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05226767
- Acronym / sponsor ID
- NLC-V-01
- Conditions
- COVID-19
- Keywords
- Coronavirus, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Todos Medical, Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Active comparator | Dietary Supplement: NLC-VPatients 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 |
| Placebo | Placebo comparator | Dietary Supplement: NLC-VPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NLC-VNLC-V | Dietary supplement | Active Arm, Placebo |
Primary outcome
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.
7 secondary outcomes
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorit Arad, PhD study chair
Todos Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NLC-V in people with COVID-19, run by Todos Medical, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.