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

• Status: Recruiting
• Trial end date: 2023-08-22
• Target enrollment: 0
• Participant gender: All

Summary

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].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novatek Pharmaceuticals

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. A resting SpO2 of >93% on room air.

3. Stated willingness to comply with all study procedures and availability for the duration of the study

4. 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

5. Positive COVID-19 infection confirmed by RT-PCR within the last 5 days of the day of randomization

6. A score of 2 (moderate) on a minimum of 1 symptom on the PRO Symptom Survey on the day of randomization

7. Ability to take oral medication and be willing to adhere to the dosing regimen (Twice a day - BID for 14 days)

8. 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

9. 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

10. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

11. 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

• Stroke or cerebrovascular disease

Exclusion Criteria:

1. 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 2. 3. Severe Covid-19 symptoms (severe per FDA classification - see appendix 3)

4. Requires immediate admission to hospital for any reason 5. Pregnancy or lactation 6. Known allergic reactions to components of black seed oil or thymoquinone 7. Treatment with another investigational drug or other investigational intervention within 2 weeks of study start and throughout study duration.

8. 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 <500/mm3 9. 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 10. Participants with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of NP-101 enteric coated capsules.

11. 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 12. Influenza diagnosis (confirmed by testing) during screening or within prior 14 days 13. Any uncontrolled condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation, as per investigator 14. Current treatment with CYP2C9 substrates (see Appendix 5)