To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants

Study Population: Up to 60 participants will be randomized 1:1 to receive either TQ Formula Capsules + Standard of Care (SOC) or placebo +SOC

Phase: Phase II

Approximately 2-4 centers in the United States

TQ Formula (Nigella Sativa) 500 mg, 3 capsules, BID, taken orally

Study Duration: 6 months

Participant Duration: Up to 45 days

Inclusion criteria

• Provision of signed and dated informed consent form
• 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 recent mild to moderate clinical symptoms of Covid-19 infection (per FDA guidance - see appendix 3)
• Positive COVID-19 infection confirmed with a rapid antigen test at screening (or RT-PCR within the last 3 days) and confirmed with a RT-PCR test at baseline
• A score of >/=3 on a minimum of 2 symptoms on the Modified FLU-PRO Plus
• 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
• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion criteria

• Current or recent (within 4 weeks) treatment with any corticosteroids; however, high-dose inhaled steroids, which are used to treat acute or chronic bronchial inflammation, will be permitted
• Current or recent (within 4 weeks) treatment with any antivirals
• Room air oxygen saturation (SaO2) < 94% at screen
• Walking oximetry < 90% or participant unable to complete 6-minute walking oximetry test at screen
• 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
• History of moderate to severe CKD, (i.e. an estimated glomerular filtration rate less than 45 mL/min) at the time of enrollment or history of liver disease
• Patients with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of TQ Formula enteric coated capsules.
• Known HIV or Hepatitis C 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