Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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 Covid-19. The main question\[s\] it aims to answer are: * To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in high risk Covid-19 positive patients. Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Key facts

Study ID

NCT05785390

Run by

Novatek Pharmaceuticals

People needed

170

Starts

2023-02-22

Expected to finish

2025-05-09

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• A resting SpO2 of >93% on room air.
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 and over, presenting with mild to moderate clinical symptoms of Covid- 19 infection (per FDA guidance - see appendix 3) with symptom onset within 5 days prior to the day of randomization
• Positive COVID-19 infection confirmed by RT-PCR within the last 5 days of the day of randomization
• A score of ≥ 2 (moderate) on a minimum of 1 symptom on the PRO Symptom Survey on the day of randomization
• Ability to take oral medication and be willing to adhere to the dosing regimen (Twice a day - BID for 14 days)
• For females of reproductive potential: negative pregnancy test at screening and use of highly effective contraception method during study participation and for an additional 4 weeks after the end of study drug administration
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration
• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
• To be considered high risk, participants should have at least one of the following conditions:
• age ≥60 years;
• active cancer
• chronic kidney disease;
• chronic lung disease including COPD
• Obesity (BMI ≥30)
• serious heart conditions [heart failure, coronary artery disease, or cardiomyopathies];
• Diabetes (type 1 or type 2)
• Immunocompromised state (weakened immune system or autoimmune diseases)
• Chronic liver disease
• Cystic fibrosis
• HIV infection
• Smoking, current or former
• Sickle cell disease or thalassemia
• Solid organ or blood stem cell transplant

You may not qualify if…

• Current or recent (within 4 weeks) treatment with any corticosteroids; however, inhaled steroids, which are used to treat acute or chronic bronchial inflammation, will be permitted
• Severe Covid-19 symptoms (severe per FDA classification - see appendix 3)
• Requires immediate admission to hospital for any reason
• Pregnancy or lactation
• Known allergic reactions to components of black seed oil or thymoquinone
• Treatment with another investigational drug or other investigational intervention within 2 weeks of study start and throughout study duration.
• Significant hepatic disease (ALT/AST> 4 times the ULN); any laboratory parameter >/= 4 times the ULN or platelet count <100,000/µ L or neutrophilic granulocyte absolute count
• o <500/mm3
• History of moderate to severe CKD, (i.e. on hemodialysis or has an estimated glomerular filtration rate less than 45mL/min) at the time of enrollment
• Participants with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of NP-101 enteric coated capsules.
• Known uncontrolled HIV (with a recent viral load > 50 copies/mL or CD4<200 cells/mm3 or known active uncontrolled Hepatitis B (defined as HBsAg-positive or detectable HBV DNA viral load) or known active Hepatitis C (defined as detectable HCV RNA viral load) infection
• Influenza diagnosis (confirmed by testing) during screening or within prior 14 days
• Any uncontrolled condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation, as per investigator
• Current treatment with CYP2C9 substrates (see Appendix 5)

Where it is running

• L&A Morales Healthcare/ Enrique Villa, MD Principal Investigator — Miami, Florida, United States
• Research Network America — Berwyn, Illinois, United States
• Clinical Trial Network — Houston, Texas, United States
• Pearland Family Wellness Clinic — Pearland, Texas, United States

Full record on ClinicalTrials.gov

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