Clinical trial NCT04914377: To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: TQ Formula
Covid 19
Lead sponsor: Novatek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. 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)
4. 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
5. A score of \>/=3 on a minimum of 2 symptoms on the Modified FLU-PRO Plus
6. Ability to take oral medication and be willing to adhere to the dosing regimen (Twice a day - BID for 14 days)
7. 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
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation
9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

1. 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
2. Current or recent (within 4 weeks) treatment with any antivirals
3. Room air oxygen saturation (SaO2) \< 94% at screen
4. Walking oximetry \< 90% or participant unable to complete 6-minute walking oximetry test at screen
5. Severe Covid-19 symptoms (severe per FDA classification - see appendix 3)
6. Requires immediate admission to hospital for any reason
7. Pregnancy or lactation
8. Known allergic reactions to components of black seed oil, or thymoquinone
9. Treatment with another investigational drug or other investigational intervention within 2 weeks of study start and throughout study duration.
10. Significant hepatic disease (ALT/AST\> 4 times the ULN); any laboratory parameter \>/= 4 times the ULN
11. 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
12. Patients with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of TQ Formula enteric coated capsules.
13. Known HIV or Hepatitis C infection
14. Influenza diagnosis (confirmed by testing) during screening or within prior 14 days
15. Any uncontrolled condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation, as per investigator
16. Current treatment with CYP2C9 substrates

Primary outcomes:
measure: Median Time to Sustained Clinical Response
timeFrame: 21 Days
measure: Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations
timeFrame: From the date of randomization up to Last Visit date on Day-45
Secondary outcomes:
measure: Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)
timeFrame: 14 Days
measure: Number and Percentages of Study Participants With Viral Clearance
timeFrame: 14 Days
measure: Severity and Change in Covid Symptoms
timeFrame: 14 Days
measure: Correlation Between Covid Symptoms and Viral Load
timeFrame: 14 Days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Respire Research
state: California
city: Hialeah
country: United States
facility: L & A Morales Healthcare
state: Florida
city: Houston
country: United States
facility: United Memorial Medical Center
state: Texas
Study officials:
affiliation: Novatek Pharmaceuticals
name: Ahmed Kaseb, MD
role: STUDY_DIRECTOR
References: