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

Covid19 Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914377
• Other study ID #: BOSS-001
• Status: Completed
• Phase: Phase 2
• Start date: June 8, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Novatek Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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).

Locations

Country	Name	City	State
United States	L & A Morales Healthcare	Hialeah	Florida
United States	United Memorial Medical Center	Houston	Texas
United States	Respire Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Novatek Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	21 Days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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