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

Study Overview
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Brief Summary
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This is a randomized (1:1), double-blind, placebo-controlled phase 2 study to assess safety and efficacy of Total TQ Formula (3 g daily dose of Nigella Sativa Oil) capsules versus placebo in treating patients who have tested positive for novel Coronavirus 2019 (Covid-19) in the outpatient setting. Patients will be treated at a dose of 500 mg, 3 capsules, two times a day for 14 days from date of randomization. Quantitative viral load as measured by RT-PCR will be evaluated at baseline and on days 7 and 14. Covid-19 symptoms will be measured throughout the study using Modified FLU-PRO Plus.

Detailed Description
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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

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TQ Formula in Treating Participants Who Have Tested Positive for Novel Coronavirus 2019 (BOSS-Covid-19)

Conditions
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Covid19

Intervention / Treatment
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* Drug: TQ Formula/Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, double-blind, placebo-controlled phase II study to assess the safety and efficacy of TQ Formula versus placebo in the treatment of Covid-19 in an outpatient setting. Participants will be randomized 1:1 to receive either 3 g per day of TQ Formula or placebo (identical in appearance). The participants will receive up to 14 days of dosing.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Drug<br>Capsules containing TQ Formula | Drug: TQ Formula/Tab<br>* TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).<br>* Other names: Nigella Sativa;|
| Placebo Comparator: Placebo<br>Capsules containing corn oil | Drug: TQ Formula/Tab<br>* TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).<br>* Other names: Nigella Sativa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time to Sustained Clinical Response | Measurement of the difference in median time to sustained clinical response in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo. Sustained clinical response is defined as a reduction of scores to </= 2 on all symptoms of the Modified FLU-PRO Plus. | 21 Days | 
| Safety of Investigational Product | Number of overall adverse events, related adverse reactions, and hospitalizations reported in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo. All AEs/SAEs will be captured throughout the study as per schedule of assessments. | Day 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quantitative Viral Load | Measurement of change in quantitative viral load from baseline, Day 7, and Day 14 using RT-PCR in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo with COVID-19 infection. | 14 Days | 
| Viral Clearance | Percentage of negative/undetectable RT-PCR (i.e., viral clearance) on Day-7 and Day-14 in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo | 14 Days | 
| Severity and Change in Covid Symptoms | Measurement of severity of, and change in, Covid-19 symptoms per total score as well as sub-scores (Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, Taste/Smell) measured through Modified FLU-PRO Plus from Day 1 through Day 14 in participants with COVID-19 infection treated either with 3 g TQ Formula (500 mg per capsule, 3 capsules BID) or placebo. | 14 Days | 
| Correlation between Covid Symptoms and Viral Load | Correlation Coefficient of quantitative viral load and symptom severity at baseline, at Day 7, and Day 14 in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TQ Formula, Covid 19