Covid19
Conditions
Keywords
TQ Formula, Covid 19
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
Interventions
DRUGTQ 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).
Sponsors
Novatek Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind study
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Drug Capsules containing TQ Formula
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). | 29 |
| Placebo Capsules containing corn oil
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). | 26 |
| Total | 55 |
Baseline characteristics
| Characteristic | Active Drug | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 45.48 years STANDARD_DEVIATION 19.29 | 45.92 years STANDARD_DEVIATION 15.27 | 45.69 years STANDARD_DEVIATION 17.35 |
| Baseline Viral Load assessment | 16499 Copies per mililiter of blood STANDARD_DEVIATION 10712 | 15418 Copies per mililiter of blood STANDARD_DEVIATION 11465 | 16002 Copies per mililiter of blood STANDARD_DEVIATION 10964 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 20 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 9 Participants | 22 Participants |
| Race (NIH/OMB) White | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 26 |
| other Total, other adverse events | 4 / 29 | 6 / 26 |
| serious Total, serious adverse events | 0 / 29 | 1 / 26 |
Outcome results
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 \</= 2 on all symptoms of the Modified FLU-PRO Plus.
Time frame: 21 Days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Drug | Median Time to Sustained Clinical Response | 6 Days |
| Placebo | Median Time to Sustained Clinical Response | 8 Days |
Primary
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.
Time frame: From the date of randomization up to Last Visit date on Day-45
Population: This analysis population includes all patients enrolled, randomized, and received at least one dose of the assigned treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Drug | Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations | 4 Participants |
| Placebo | Number and Percentage of Participants With Overall Adverse Events, Related Adverse Reactions, and Hospitalizations | 7 Participants |
Secondary
Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)
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.
Time frame: 14 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Drug | Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline) | 13681.67 copies/mL | Standard Error 13169.47 |
| Placebo | Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline) | 9023.63 copies/mL | Standard Error 15350.44 |
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
Time frame: 14 Days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Drug | Correlation Between Covid Symptoms and Viral Load | Baseline | -0.29 Correlation Coefficient |
| Active Drug | Correlation Between Covid Symptoms and Viral Load | Day-7 | -0.51 Correlation Coefficient |
| Active Drug | Correlation Between Covid Symptoms and Viral Load | Day-14 | -0.17 Correlation Coefficient |
| Placebo | Correlation Between Covid Symptoms and Viral Load | Baseline | -0.51 Correlation Coefficient |
| Placebo | Correlation Between Covid Symptoms and Viral Load | Day-7 | -0.53 Correlation Coefficient |
| Placebo | Correlation Between Covid Symptoms and Viral Load | Day-14 | -0.37 Correlation Coefficient |
Secondary
Number and Percentages of Study Participants With Viral Clearance
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
Time frame: 14 Days
Population: Patients who had RT-PCR test on Day-14 that was not indeterminate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Drug | Number and Percentages of Study Participants With Viral Clearance | 16 Participants |
| Placebo | Number and Percentages of Study Participants With Viral Clearance | 11 Participants |
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. 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.
Time frame: 14 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Drug | Severity and Change in Covid Symptoms | Throat Symptom Burden within the first 14 days based on 2 questions on a possible scale of 0 to 8 | 0.42 Score on a scale | Standard Deviation 0.52 |
| Active Drug | Severity and Change in Covid Symptoms | GI Symptom Burden within the first 14 days based on 4 questions on a possible scale of 0 to 16 | 0.91 Score on a scale | Standard Deviation 1.1 |
| Active Drug | Severity and Change in Covid Symptoms | Nose Symptom Burden within the first 14 days based on 1 question on a possible scale of 0 to 4 | 0.54 Score on a scale | Standard Deviation 0.55 |
| Active Drug | Severity and Change in Covid Symptoms | Body/systemic Sympt. Burden in the first 14 days based on 8 questions on a possible scale of 0 to 32 | 6.10 Score on a scale | Standard Deviation 4.34 |
| Active Drug | Severity and Change in Covid Symptoms | Respiratory Symptom Burden in the first 14 days based on 7 questions on a possible scale of 0 to 28 | 3.48 Score on a scale | Standard Deviation 4.26 |
| Active Drug | Severity and Change in Covid Symptoms | Smell/Taste Sympt. Burden in the first 14 days based on 2 questions on a possible scale of 0 to 8 | 1.19 Score on a scale | Standard Deviation 1.47 |
| Active Drug | Severity and Change in Covid Symptoms | Total Symptom Burden within the first 14 days based on 24 questions on a possible scale of 0 to 96 | 12.65 Score on a scale | Standard Deviation 8.78 |
| Placebo | Severity and Change in Covid Symptoms | Smell/Taste Sympt. Burden in the first 14 days based on 2 questions on a possible scale of 0 to 8 | 2.03 Score on a scale | Standard Deviation 2.09 |
| Placebo | Severity and Change in Covid Symptoms | Total Symptom Burden within the first 14 days based on 24 questions on a possible scale of 0 to 96 | 17.05 Score on a scale | Standard Deviation 8.78 |
| Placebo | Severity and Change in Covid Symptoms | Nose Symptom Burden within the first 14 days based on 1 question on a possible scale of 0 to 4 | 0.77 Score on a scale | Standard Deviation 0.55 |
| Placebo | Severity and Change in Covid Symptoms | Throat Symptom Burden within the first 14 days based on 2 questions on a possible scale of 0 to 8 | 1.03 Score on a scale | Standard Deviation 1.55 |
| Placebo | Severity and Change in Covid Symptoms | Respiratory Symptom Burden in the first 14 days based on 7 questions on a possible scale of 0 to 28 | 4.65 Score on a scale | Standard Deviation 4.78 |
| Placebo | Severity and Change in Covid Symptoms | GI Symptom Burden within the first 14 days based on 4 questions on a possible scale of 0 to 16 | 1.48 Score on a scale | Standard Deviation 1.72 |
| Placebo | Severity and Change in Covid Symptoms | Body/systemic Sympt. Burden in the first 14 days based on 8 questions on a possible scale of 0 to 32 | 7.08 Score on a scale | Standard Deviation 5.18 |