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

Sponsor
Novatek Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04914377
Collaborator
(none)
60
Enrollment
3
Locations
2
Arms
6.8
Actual Duration (Months)
20
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TQ Formula/Tab
 Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Investigator)
Masking Description:
Double-blind study
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 8, 2021
Actual Primary Completion Date :
Dec 16, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Drug

Capsules containing TQ Formula

Drug: TQ Formula/Tab
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).
Other Names:
  • Nigella Sativa

    		•
    Placebo Comparator: Placebo

    Capsules containing corn oil

    Drug: TQ Formula/Tab
    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).
    Other Names:
  • Nigella Sativa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Median Time to Sustained Clinical Response [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.

    2. Safety of Investigational Product [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.

    Secondary Outcome Measures

    1. Change in Quantitative Viral Load [14 Days]

      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.

    2. Viral Clearance [14 Days]

      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

    3. Severity and Change in Covid Symptoms [14 Days]

      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.

    4. Correlation between Covid Symptoms and Viral Load [14 Days]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • Novatek Pharmaceuticals

    Investigators

    • Study Director: Ahmed Kaseb, MD, Novatek Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novatek Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04914377
    Other Study ID Numbers:
    • BOSS-001
    First Posted:
    Jun 4, 2021
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novatek Pharmaceuticals
    TQ Formula
    Covid 19
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 25, 2022