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

NCT05785390

TerminatedPhase 2

Sponsor: Novatek Pharmaceuticals

Conditions: COVID-19

Interventions: NP-101, Placebo

Countries: United States

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 \[insert effects\].

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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
  * Stroke or cerebrovascular disease

Exclusion Criteria:

* 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)
Locations (4)
  • Miami, Florida, United States
  • Berwyn, Illinois, United States
  • Houston, Texas, United States
  • Pearland, Texas, United States