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

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)

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: TQ Formula/Tab

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92108
      • RESPIRE Research
  • Florida
    • Hialeah, Florida, United States, 33018
      • L & A Morales Healthcare
  • Texas
    • Houston, Texas, United States, 77054
      • United Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 Days
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.	Day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 Days
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	14 Days
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.	14 Days
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	14 Days

Collaborators and Investigators

• Sponsor: Novatek Pharmaceuticals
• Investigators: Study Director: Ahmed Kaseb, MD, Novatek Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Covid 19; TQ Formula
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BOSS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: November - December 2021
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No