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

NCT ID: NCT04914377

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2022-01-01

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

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Drug

Capsules containing TQ Formula

Group Type: EXPERIMENTAL

TQ Formula/Tab

Intervention Type: DRUG

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).

Placebo

Capsules containing corn oil

Group Type: PLACEBO_COMPARATOR

TQ Formula/Tab

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Nigella Sativa

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novatek Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Kaseb, MD

Role: STUDY_DIRECTOR

Novatek Pharmaceuticals

Locations

Respire Research

San Diego, California, United States

L & A Morales Healthcare

Hialeah, Florida, United States

United Memorial Medical Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BOSS-001

Identifier Type: -

Identifier Source: org_study_id