NP-101 for COVID-19

(BOSS-002 Trial)

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

170 Participants Needed

Trial Summary

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.

How does the NP-101 treatment for COVID-19 differ from other treatments?

The NP-101 treatment is unique because it is administered as a nasal spray, which is different from many other COVID-19 treatments that are typically oral or intravenous. This nasal spray is designed to prevent SARS-CoV-2 infection, particularly in high-risk healthcare workers, by reducing the chance of the virus entering the body through the nasal passages. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing NP-101, a new treatment for high-risk Covid-19 patients. It aims to find the safest and most effective dose by comparing different amounts of the treatment. Participants will receive either NP-101 or another form of care, along with the best supportive care.

Research Team

Ahmed Kaseb, MD

Principal Investigator

Novatek Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

A Randomized, Open-Label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID-19, a Pilot Study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Bioluminescent Imaging Mouse Model for SARS-CoV-2 Infection Based on a Pseudovirus System. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Complete Protection from SARS-CoV-2 Lung Infection in Mice Through Combined Intranasal Delivery of PIKfyve Kinase and TMPRSS2 Protease Inhibitors. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Multicenter Randomized Controlled Trial To Evaluate the Efficacy and Safety of Nelfinavir in Patients with Mild COVID-19. [2023]