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

Phase 2

Completed

• Conditions: Covid19
• Interventions: Drug: TQ Formula/Tab

• Registration Number: NCT04914377
• Lead Sponsor: Novatek Pharmaceuticals

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

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-04
• Study Start: 2021-06-08
• Primary Completion: 2021-12-16
• Study Completion: 2022-01-01
• Results First Submitted: 2024-03-22
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	TQ Formula/Tab	Capsules containing corn oil
Active Drug	TQ Formula/Tab	Capsules containing TQ Formula

Primary Outcome Measures

Name	Time	Method
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.
Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations	From the date of randomization up to Last Visit date on 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

Name	Time	Method
Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)	14 Days	Measurement of change in quantitative viral load from baseline to Day 14 using RT-PCR (day-14 minus baseline) in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo with COVID-19 infection.
Number and Percentages of Study Participants With Viral Clearance	14 Days	Percentage of negative/undetectable RT-PCR (i.e., viral clearance) on Day-14 in participants taking 3 g TQ Formula (500 mg per capsule, 3 capsules BID) versus participants taking placebo
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.; 1. Total Symptom Score is based on 24 questions with a possible range 0-96; 2. Nose Symptom Score is based on a single question with a possible scale 0-4; 3. Throat Throat Symptom is based on 2 questions with a possible scale 0-8; 4. Respiratory Symptom is based on 7 questions with a possible scale 0-28; 5. GI symptom score is based on 4 questions with a possible scale 0-16; 6. Body/Systemic Symptom Score is based on 8 questions with a possible scale 0-32; 7. Smell/Taste Symptom Score is based on 2 questions with a possible scale 0-8 In each of these scales, higher scores mean higher symptom burden.
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

Trial Locations

Locations (3)

L & A Morales Healthcare; 🇺🇸 Hialeah, Florida, United States

United Memorial Medical Center; 🇺🇸 Houston, Texas, United States

Respire Research; 🇺🇸 San Diego, California, United States