To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants (BOSS)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TQ Formula/Tab
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring TQ Formula, Covid 19
Eligibility Criteria
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
Sites / Locations
- Respire Research
- L & A Morales Healthcare
- United Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Drug
Placebo
Arm Description
Capsules containing TQ Formula
Capsules containing corn oil
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04914377
Brief Title
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
Acronym
BOSS
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novatek Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
TQ Formula, Covid 19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Double-blind study
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Drug
Arm Type
Experimental
Arm Description
Capsules containing TQ Formula
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules containing corn oil
Intervention Type
Drug
Intervention Name(s)
TQ Formula/Tab
Other Intervention Name(s)
Nigella Sativa
Intervention Description
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).
Primary Outcome Measure Information:
Title
Median Time to Sustained Clinical Response
Description
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.
Time Frame
21 Days
Title
Safety of Investigational Product
Description
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.
Time Frame
Day 45
Secondary Outcome Measure Information:
Title
Change in Quantitative Viral Load
Description
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.
Time Frame
14 Days
Title
Viral Clearance
Description
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
Time Frame
14 Days
Title
Severity and Change in Covid Symptoms
Description
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.
Time Frame
14 Days
Title
Correlation between Covid Symptoms and Viral Load
Description
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
Time Frame
14 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Kaseb, MD
Organizational Affiliation
Novatek Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Respire Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
L & A Morales Healthcare
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Facility Name
United Memorial Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
November - December 2021
Learn more about this trial
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
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