Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (BOSS-002)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, High Risk, Outpatient
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)
Sites / Locations
- L&A Morales Healthcare/ Enrique Villa, MD Principal InvestigatorRecruiting
- Research Network AmericaRecruiting
- Clinical Trial NetworkRecruiting
- Pearland Family Wellness ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active Drug Treatment
Placebo
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.
As above, except dosed with matching placebo capsules.