Status:
COMPLETED
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
Lead Sponsor:
Novatek Pharmaceuticals
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04914377
Start Date
June 8 2021
End Date
January 1 2022
Last Update
August 14 2024
Active Locations (3)
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1
Respire Research
San Diego, California, United States, 92108
2
L & A Morales Healthcare
Hialeah, Florida, United States, 33018
3
United Memorial Medical Center
Houston, Texas, United States, 77054