NP-101 for COVID-19

(BOSS-002 Trial)

No longer recruiting at 3 trial locations

Overseen By Michelle Y Gocio, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novatek Pharmaceuticals

Must not be taking: Corticosteroids, CYP2C9 substrates

Disqualifiers: Severe Covid-19, Pregnancy, Uncontrolled HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of NP-101 for treating high-risk individuals who have tested positive for COVID-19. Participants will receive either NP-101, a new potential drug, or a placebo, a pill with no active medicine, to compare their effectiveness. The study will test different doses of NP-101 to identify the highest safe amount. This trial suits those with mild to moderate COVID-19 symptoms, who tested positive in the last five days, and have conditions like diabetes or heart disease. Participants will take capsules twice daily for 14 days. As a Phase 2 trial, this research measures NP-101's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking corticosteroids (except inhaled ones) and any medications that are CYP2C9 substrates. If you're on these, you may need to stop them before joining the trial.

Is there any evidence suggesting that NP-101 is likely to be safe for humans?

Research has shown that NP-101 has undergone safety testing in humans. The ingredients in NP-101, such as thymoquinone and certain fatty acids, have demonstrated potential in combating the virus that causes COVID-19. However, some safety data suggest careful handling of NP-101 is necessary. It remains hazardous until more information becomes available, so avoid ingesting it or allowing contact with skin or eyes without proper guidance.

This trial is in an early phase, indicating that while the treatment appears promising, its safety is still under close examination. This phase aims to determine the maximum safe dosage without adverse side effects. So far, no major unexpected medical problems have been reported. Participants in this trial will assist researchers in assessing the safety and tolerability of NP-101 for treating COVID-19. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Most treatments for COVID-19, like antivirals and monoclonal antibodies, aim to reduce viral load and prevent severe symptoms. However, NP-101 is unique because it is being explored at various escalating doses to establish the maximum tolerated dose that could potentially enhance its effectiveness. Researchers are excited about NP-101 as it offers a new dosing strategy that could optimize treatment outcomes, providing a tailored approach to fighting COVID-19 in a way that current treatments do not.

What evidence suggests that NP-101 might be an effective treatment for COVID-19?

Research has shown that NP-101 contains Thymoquinone, an ingredient that may help reduce COVID-19 symptoms. Studies suggest that this ingredient can speed up recovery and increase the likelihood of symptom resolution in adults with mild COVID-19. Thymoquinone also appears to prevent the virus from infecting cells, potentially stopping the illness from worsening. Although more research is needed, these early findings indicate that NP-101 could effectively treat COVID-19, especially in high-risk patients. Participants in this trial will receive either NP-101 or a placebo to evaluate its effectiveness. ^{2 4 6 7 8}

Who Is on the Research Team?

Ahmed Kaseb, MD

Principal Investigator

Novatek Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mild to moderate COVID-19 symptoms, diagnosed within the last 5 days. Participants must have high-risk factors like being over 60 or having certain chronic diseases. They should be able to take oral meds and follow study procedures, including effective contraception use.

Inclusion Criteria

Your oxygen level while resting is higher than 93% when breathing normal air.

You are 18 years or older and have mild to moderate symptoms of Covid-19 that started within the last 5 days.

Provision of signed and dated informed consent form

Exclusion Criteria

You have a condition like Crohn's disease that might affect how your body absorbs the study drug in capsule form.

You have severe liver disease or very low levels of certain blood measurements.

You have had moderate to severe chronic kidney disease at the time of joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase IIa

Dose escalation study to determine the maximum tolerated dose of NP-101

14 days per dose

Multiple visits for dose escalation monitoring

Treatment Phase IIb

Participants receive the maximum tolerated dose of NP-101 or placebo

14 days

Regular visits for safety and efficacy assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Through Day 45

Follow-up visits to assess adverse events and recovery

What Are the Treatments Tested in This Trial?

Interventions

• NP-101
• Placebo

Trial Overview The trial tests NP-101's safety and effectiveness against COVID-19 in high-risk patients, determining the highest dose they can tolerate without severe side effects. Patients will receive either NP-101 or a placebo twice daily for two weeks while their health outcomes are monitored.

How Is the Trial Designed?

Group I: Active Drug Treatment Experimental Treatment 1 Intervention

Phase IIa - Dose escalation. 3g cohort and 4.8g cohort run simultaneously, followed by a 6 g cohort. Administered in 600 g capsules of NP-101 for a total daily dose of 3g, 4.8g and 6g adminstered BID. Administered for 14 days.Establish MTDD Phase IIB - Continue study with MTDD as established above.

Group II: Placebo Placebo Group 1 Intervention

As above, except dosed with matching placebo capsules.

Who Is Running the Clinical Trial?

Novatek Pharmaceuticals

Lead Sponsor

Trials

3

Recruited

380+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10876831/

Individual ingredients of NP-101 (Thymoquinone formula ... Its use was associated with a higher chance of resolution of symptoms and faster recovery in adult patients with mild COVID-19 (Koshak et al., ...

2. researchgate.net researchgate.net/publication/378371206_Individual_ingredients_of_NP-101_Thymoquinone_formula_inhibit_SARS-CoV-2_pseudovirus_infection?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

(PDF) Individual ingredients of NP-101 (Thymoquinone ... Thymoquinone TQ, an active ingredient of Nigella Sativa, has been shown to inhibit COVID-19 symptoms in clinical trials.

3. researchgate.net researchgate.net/publication/360471960_A_Randomized_Double-Blind_Placebo-Controlled_Multicenter_Study_to_Evaluate_the_Safety_and_Efficacy_of_ThymoQuinone_Formula_TQF_for_Treating_Outpatient_SARS-CoV-2

(PDF) A Randomized, Double-Blind, Placebo-Controlled ... A large, randomized phase 2 study of NP-101 is planned in outpatient COVID-19 patients. ... Individual ingredients of NP-101 (Thymoquinone formula) inhibit SARS- ...

4. ctv.veeva.com ctv.veeva.com/study/study-of-the-safety-tolerability-and-efficacy-of-np-101-in-treating-high-risk-participants-who-are

Study of the Safety, Tolerability and Efficacy of NP-101 in ... The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive for ...

5. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07418-y

SARS-CoV-2 vaccine effectiveness against infection ... VE against all SARS-CoV-2 infections declined from 83% in the first month after completion of the original vaccination series to 22% at 5 months or longer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05785390

Study of the Safety, Tolerability and Efficacy of NP-101 in ... The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/insert/31984.pdf

PRODUCT INFORMATION SAFETY DATA. This material should be considered hazardous until further information becomes available. Do not ingest, inhale, get in eyes, on skin, ...

8. uspharmacist.com uspharmacist.com/article/covid19-vaccine-safety-update

COVID-19 Vaccine Safety Update This article will provide an update on safety data for the COVID-19 vaccines, excluding Janssen's. The latest recommendations of the ...