Covid19Phase 2BOSSNCT04914377
To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants
A Phase 2 study testing TQ Formula/Tab in people with Covid19, run by Novatek Pharmaceuticals at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- TQ Formula/Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jun 2021to 1 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
- Current treatment with CYP2C9 substrates
Trial locations and contacts
3 sites in 1 country.
United States3 sites
L & A Morales Healthcare
Hialeah, Florida, 33018
United Memorial Medical Center
Houston, Texas, 77054
Respire Research
San Diego, California, 92108
About this study
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)
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.
Read the 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
- Being tested
- TQ Formula/Tab
- Keywords
- TQ Formula, Covid 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ Formula/TabDrug
Also called Nigella Sativa
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).
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Experimental | Capsules containing TQ Formula Receives: Drug: TQ Formula/Tab |
| Placebo | Placebo comparator | Capsules containing corn oil Receives: Drug: TQ Formula/Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 14 Days
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
Measured: 14 Days
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.
- Total Symptom Score is based on 24 questions with a possible range 0-96
- Nose Symptom Score is based on a single question with a possible scale 0-4
- Throat Throat Symptom is based on 2 questions with a possible scale 0-8
- Respiratory Symptom is based on 7 questions with a possible scale 0-28
- GI symptom score is based on 4 questions with a possible scale 0-16
- Body/Systemic Symptom Score is based on 8 questions with a possible scale 0-32
- 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.
Measured: 14 Days
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
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start8 Jun 2021
- Primary completion16 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novatek Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Kaseb, MD, Study director, Novatek Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914377
- Sponsor's protocol ID
- BOSS-001
- Acronym
- BOSS
- Status last verified
- Jul 2024
- First submitted
- 2 Jun 2021
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04914377
- Acronym / sponsor ID
- BOSS / BOSS-001
- Conditions
- Covid19
- Keywords
- TQ Formula, Covid 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novatek PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Experimental | Drug: TQ Formula/TabCapsules containing TQ Formula |
| Placebo | Placebo comparator | Drug: TQ Formula/TabCapsules containing corn oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ Formula/TabAlso: Nigella SativaTQ 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). | Drug | Active Drug, Placebo |
Primary outcome
Median Time to Sustained Clinical Response
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change of Quantitative Viral Load From Baseline Assessment to Day-14 (Day-14 Minus Baseline)
Time frame: 14 Days
Number and Percentages of Study Participants With Viral Clearance
Time frame: 14 Days
Severity and Change in Covid Symptoms
Time frame: 14 Days
Correlation Between Covid Symptoms and Viral Load
Time frame: 14 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Kaseb, MD study director
Novatek Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQ Formula/Tab in people with Covid19, run by Novatek Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time to Sustained Clinical Response (time frame: 21 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.