Clinical Research Directory

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)