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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Median Time to Sustained Clinical Response
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Drug
Capsules containing TQ Formula
干预措施: TQ Formula/Tab (Drug)
Placebo
Capsules containing corn oil
干预措施: TQ Formula/Tab (Drug)
结局指标
主要结局
Median Time to Sustained Clinical Response
时间窗: 21 Days
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.
Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations
时间窗: From the date of randomization up to Last Visit date on Day-45
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.
次要结局
- Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)(14 Days)
- Number and Percentages of Study Participants With Viral Clearance(14 Days)
- Severity and Change in Covid Symptoms(14 Days)
- Correlation Between Covid Symptoms and Viral Load(14 Days)