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

NCT04914377 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BOSS-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Keywords

TQ Formula; Covid 19

Outcome Measures

Primary Outcomes (2)

• 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

• Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations

  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.

  From the date of randomization up to Last Visit date on Day-45

Secondary Outcomes (4)

• Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)

  14 Days

• Number and Percentages of Study Participants With Viral Clearance

  14 Days

• Severity and Change in Covid Symptoms

  14 Days

• Correlation Between Covid Symptoms and Viral Load

  14 Days

Study Arms (2)

Active Drug

EXPERIMENTAL

Capsules containing TQ Formula

Drug: TQ Formula/Tab

Placebo

PLACEBO COMPARATOR

Capsules containing corn oil

Drug: TQ Formula/Tab

Interventions

TQ Formula/Tab 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).

Also known as: Nigella Sativa

Active Drug; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novatek Pharmaceuticals: lead

Study Sites (3)

Respire Research

San Diego, California, 92108, United States

Location

L & A Morales Healthcare

Hialeah, Florida, 33018, United States

Location

United Memorial Medical Center

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ahmed Kaseb MD
• Organization: Novatek Pharmaceuticals

akaseb@novatekpharmaceuticals.com

877-662-8351

Study Officials

• Ahmed Kaseb, MD

  Novatek Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 4, 2021
• Study Start: June 8, 2021
• Primary Completion: December 16, 2021
• Study Completion: January 1, 2022
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: November - December 2021

Locations

US (3)