COVID-19Phase 2BOSS-002NCT05785390
Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.
A Phase 2 study testing NP-101 in people with COVID-19, run by Novatek Pharmaceuticals at 4 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive for Covid-19. The main question[s] it aims to answer are: To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in high risk Covid-19… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- NP-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Feb 2023to 9 May 2025
- 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
- A resting SpO2 of >93% on room air.
- 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 mild to moderate clinical symptoms of Covid- 19 infection (per FDA guidance - see appendix 3) with symptom onset within 5 days prior to the day of randomization
- Positive COVID-19 infection confirmed by RT-PCR within the last 5 days of the day of randomization
- A score of ≥ 2 (moderate) on a minimum of 1 symptom on the PRO Symptom Survey on the day of randomization
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- 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 and for an additional 4 weeks after the end of study drug administration
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
- To be considered high risk, participants should have at least one of the following conditions:
- age ≥60 years;
- active cancer
- chronic kidney disease;
- chronic lung disease including COPD
- Obesity (BMI ≥30)
- serious heart conditions [heart failure, coronary artery disease, or cardiomyopathies];
- Diabetes (type 1 or type 2)
- Immunocompromised state (weakened immune system or autoimmune diseases)
- Chronic liver disease
- Cystic fibrosis
- HIV infection
- Smoking, current or former
- Sickle cell disease or thalassemia
- Solid organ or blood stem cell transplant
- Stroke or cerebrovascular disease
Who cannot join
- Current or recent (within 4 weeks) treatment with any corticosteroids; however, inhaled steroids, which are used to treat acute or chronic bronchial inflammation, will be permitted
- 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.
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- Significant hepatic disease (ALT/AST> 4 times the ULN); any laboratory parameter >/= 4 times the ULN or platelet count <100,000/µ L or neutrophilic granulocyte absolute count
- o <500/mm3
- History of moderate to severe CKD, (i.e. on hemodialysis or has an estimated glomerular filtration rate less than 45mL/min) at the time of enrollment
- Participants with inflammatory bowel disease (such as Crohn's) that could affect the intestinal absorption of NP-101 enteric coated capsules.
- Known uncontrolled HIV (with a recent viral load > 50 copies/mL or CD4<200 cells/mm3 or known active uncontrolled Hepatitis B (defined as HBsAg-positive or detectable HBV DNA viral load) or known active Hepatitis C (defined as detectable HCV RNA viral load) 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 (see Appendix 5)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Network America
Berwyn, Illinois, 60402
Clinical Trial Network
Houston, Texas, 77074
L&A Morales Healthcare/ Enrique Villa, MD Principal Investigator
Miami, Florida, 33142
Pearland Family Wellness Clinic
Pearland, Texas, 77584
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase IIa/IIb Study to Evaluate the Safety, Tolerability, and Efficacy of NP-101 in Treating High-Risk Participants Who Have Tested Positive for Novel Coronavirus 2019.
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive for Covid-19. The main question[s] it aims to answer are:
- To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in high risk Covid-19 positive patients.
Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].
Read the detailed description
This is a Phase IIa/IIb multicenter, interventional, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of NP-101 in outpatient high-risk COVID-19 positive participants. Blinding roles: Participants, Investigators and Sponsor
The study is comprised of two parts (Phase IIa and Phase IIb) and four cohorts. The first part of the trial (IIa) involves three cohorts and is a dose escalation study designed to select the maximum tolerated dose for use in the second part (IIb) of the study. In the dose escalation (Phase IIa) portion of the trial (n= 60), qualified participants will be enrolled in a parallel dose escalation design and randomized in a 3:1 [active+best supportive care (BSC):placebo+BSC]ratio to one of three cohorts of 20 participants each (15 active +BSC, 5 placebo + BSC). Cohort 1 (15 participants taking 600 mg capsules for a total daily dose of 3 grams of NP-101 plus BSC and 5 participants taking placebo plus BSC), and Cohort 2 (15 participants taking 600 mg capsules for a total daily dose of 4.8 g of NP-101+ BSC and 5 participants taking placebo plus BSC will run concurrently since acceptable safety data for the 3 g dose was obtained in an earlier phase II study.
Cohort 1 will receive either 3 g Total Daily Dose (TDD) of NP-101 + BSC or Placebo+ BSC, Cohort 2 will receive either 4.8 g TDD of NP-101 +BSC or placebo + BSC) and Cohort 3 (15 participants taking 600 mg capsules for a total daily dose of 6 g of NP-101 + BSC and 5 participants taking placebo plus BSC.) Safety will be evaluated according to the terms of the Statistical Analysis Plan (SAP). In the second portion of the trial (Phase IIb), Participants enrolled in Cohort 4 (n= 248) will be randomized in a ratio of 1:1 (active+BSC : placebo+BSC) and will receive the Maximum Tolerated Daily Dose (MTDD) as determined by the parameters set by the SAP and approved by the pharmacovigilance team.
- Conditions
- COVID-19
- Being tested
- NP-101, Placebo
- Keywords
- COVID-19, High Risk, Outpatient
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-101Drug
Also called TQ Formula
NP-101 is an organically derived, GMP manufactured product covered under IND #152687.
PlaceboOther
Identical placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Drug Treatment | Experimental | Phase IIa - Dose escalation. 3g cohort and 4.8g cohort run simultaneously, followed by a 6 g cohort. Administered in 600 g capsules of NP-101 for a total daily dose of 3g, 4.8g and 6g adminstered BID. Administered for 14 days.Establish MTDD Phase IIB - Continue study with MTDD as established above. Receives: Drug: NP-101 |
| Placebo | Placebo comparator | As above, except dosed with matching placebo capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of MTDD
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold. This outcome measure ONLY APPLIES TO the Phase-IIa (Dose-finding) component of the trial.
Measured: Fourteen days per dose (Phase IIA Only)
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Evaluation of the number of overall adverse events, related adverse reactions, adverse events leading to discontinuation of study drug, hospitalization, or death.
Measured: Through Day 45
Time to Sustained Clinical Recovery
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
This outcome measure is defined as the difference of Sustained Clinical Recovery (SCR) rates on Day 5 in patients taking the MTDD of NP-101 vs Placebo.
Measured: Through Day 5
Secondary outcomes (17)
Difference of Change in Log2 of Viral Load From Baseline to Day-7 Between NP-101 and Placebo
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Measured: Enrollment to Day-7 on study
Difference of Change in ORF1 Gene From Baseline to Day-7 Between NP-101 and Placebo
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7
Measured: Enrollment to Day-7
Difference in Change of E-Gene From Baseline to Day-7 Between N101 and Placebo
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Measured: From Enrollment to Day-7
Differenc in Change of N-Gene From Baseline to Day-7 Between NP-101 and Placebo
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. .
With this outcome measure, we aim to compare the change in viral load and cycle threshold profiles from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. As Viral Load and Cycle Threshold values were not available on Day-14 as the RT-PCR assessment of Covid-19 was negative, we are able to provide the change only from Baseline to Day-7.
Measured: From enrollment to Day-7
RT-PCR Negative/Undetectable Rate at Day 7
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the percentage of RT-PCR negative/undetectable (i.e., viral clearance) on Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo
Measured: Days 0 to 7
RT-PCR Negative/Undetectable on Day-14
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the percentage of RT-PCR negative/undetectable (i.e., viral clearance) on Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo
Measured: Day 0 to Day-14
Median Time to Sustained Clinical Recovery
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this aim, we compare the median days from randomization to the attainment of Sustained Clinical Recovery between NP-101 and Placebo arms
Measured: From Day-0 to Day-28
Median Day to Complete Clinical Recovery
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this aim, we compare the median days from randomization to the attainment of Sustained Clinical Recovery between NP-101 and Placebo arms
Measured: From Day-0 to Day-28
Median Days to Complete Clinical Resolution
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this aim, we compare the median days from randomization to the attainment of the complete clinical resolution between NP-101 and Placebo.
Measured: From Day-0 to Day-28
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+ Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. Markers are absolute counts of cells per cubic milimeter.
Measured: From Day-0 to Day-7
Difference of the Change From Randomization to Day-7 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the change in the ratio of CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. Both CD4+ and CD8+ are measured as absolute counts of cells per cubic milimeter.
Measured: From Day-0 to Day-7
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+ Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. These marker entries represent the percentages of the combination of these immune cell types or their percentages in the biological sample.
Measured: From Day-0 to Day-7 Cell Percentages
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+.
Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. Markers are absolute count of cells per cubic milimeter.
Measured: From Day*0 to Day-14
Difference of the Change From Randomization to Day-14 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the change in the ratio of CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. Both CD4+ and CD8+ are measured as absolute counts of cells per cubic milimeter.
Measured: From Day-0 to Day-14
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the change in effector immune cells, specifically CD4+ and CD8+ T lymphocytes, from Randomization to Day 7 and Day 14 in participants taking the MED of NP-101 as compared to placebo. We have a total of 36 markers for CD4+ and CD8+.
Flow cytometry markers are combinations of the following immune cell types having various immune responses singly or in combination: CD3, CD5, CD8, CD16, CD19, CD45, CCR7, and CXCR3. The flow-cytomerty markers include the immune cell types: CD3, CD4, CD8, CD16, CD19, CD45, CCR7, and CXCR3. These Markers represent the percentages of the combination of these immune cell types or their percentages in the biological sample.
Measured: From Day-0 to Day-14
Proportion of Participants With Symptom Progression
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the rate of disease progression measured by the worsening by the Covid-19 symptoms from 'none' or 'mild' to 'moderate' or 'severe' and remaining at that level for at least two days before alleviation or resolution, or the experience of hospitalization or death due to Covid-19 symptom worsening in participants taking the MED of NP-101 versus placebo
Measured: From Day-0 to Day28
Proportion of Paticipants With Long-Covid Symptoms
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry.
In this objective, we aim to compare the rate of Long- Covid symptoms in participants taking the MED of NP-101 versus placebo. A patient will be classified as having experienced symptoms indicative of Long- Covid if they reported any new or ongoing mild, moderate, or severe Long- Covid symptoms captured on the daily symptom questionnaire, on any of the following days: Day 30 ± 2 days, Day 37 ± 2 days, or Day 45 ± 2 days
Measured: Day-29 to Day-45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start22 Feb 2023
- Primary completion9 May 2025
- Study completion9 May 2025
Why it stopped: The interim analysis results met protocol and SAP predetermined criteria for stopping early due to futility or efficacy.
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 COVID-19Studies 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
- Phase IIb will be a 2 parallel arms, double - blind, randomized, placebo controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 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
- NCT05785390
- Sponsor's protocol ID
- BOSS-Covid-19-002
- Acronym
- BOSS-002
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2023
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase IIa/IIb Study to Evaluate the Safety, Tolerability, and Efficacy of NP-101 in Treating High-Risk Participants Who Have Tested Positive for Novel Coronavirus 2019.
- ClinicalTrials.gov ID
- NCT05785390
- Acronym / sponsor ID
- BOSS-002 / BOSS-Covid-19-002
- Conditions
- COVID-19
- Keywords
- COVID-19, High Risk, Outpatient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The interim analysis results met protocol and SAP predetermined criteria for stopping early due to futility or efficacy.
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Novatek PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive for Covid-19. The main question[s] it aims to answer are:
- To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in high risk Covid-19 positive patients.
Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].
Detailed description
This is a Phase IIa/IIb multicenter, interventional, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of NP-101 in outpatient high-risk COVID-19 positive participants. Blinding roles: Participants, Investigators and Sponsor
The study is comprised of two parts (Phase IIa and Phase IIb) and four cohorts. The first part of the trial (IIa) involves three cohorts and is a dose escalation study designed to select the maximum tolerated dose for use in the second part (IIb) of the study. In the dose escalation (Phase IIa) portion of the trial (n= 60), qualified participants will be enrolled in a parallel dose escalation design and randomized in a 3:1 [active+best supportive care (BSC):placebo+BSC]ratio to one of three cohorts of 20 participants each (15 active +BSC, 5 placebo + BSC). Cohort 1 (15 participants taking 600 mg capsules for a total daily dose of 3 grams of NP-101 plus BSC and 5 participants taking placebo plus BSC), and Cohort 2 (15 participants taking 600 mg capsules for a total daily dose of 4.8 g of NP-101+ BSC and 5 participants taking placebo plus BSC will run concurrently since acceptable safety data for the 3 g dose was obtained in an earlier phase II study.
Cohort 1 will receive either 3 g Total Daily Dose (TDD) of NP-101 + BSC or Placebo+ BSC, Cohort 2 will receive either 4.8 g TDD of NP-101 +BSC or placebo + BSC) and Cohort 3 (15 participants taking 600 mg capsules for a total daily dose of 6 g of NP-101 + BSC and 5 participants taking placebo plus BSC.) Safety will be evaluated according to the terms of the Statistical Analysis Plan (SAP). In the second portion of the trial (Phase IIb), Participants enrolled in Cohort 4 (n= 248) will be randomized in a ratio of 1:1 (active+BSC : placebo+BSC) and will receive the Maximum Tolerated Daily Dose (MTDD) as determined by the parameters set by the SAP and approved by the pharmacovigilance team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase IIb will be a 2 parallel arms, double - blind, randomized, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Active Drug Treatment | Experimental | Drug: NP-101Phase IIa - Dose escalation. 3g cohort and 4.8g cohort run simultaneously, followed by a 6 g cohort. Administered in 600 g capsules of NP-101 for a total daily dose of 3g, 4.8g and 6g adminstered BID. Administered for 14 days.Establish MTDD Phase IIB - Continue study with MTDD as established above. |
| Placebo | Placebo comparator | Other: PlaceboAs above, except dosed with matching placebo capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Provision of signed and dated informed consent form
- A resting SpO2 of >93% on room air.
- 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 mild to moderate clinical symptoms of Covid- 19 infection (per FDA guidance - see appendix 3) with symptom onset within 5 days prior to the day of randomization
- Positive COVID-19 infection confirmed by RT-PCR within the last 5 days of the day of randomization
Key exclusion criteria (14 listed)
- Current or recent (within 4 weeks) treatment with any corticosteroids; however, inhaled steroids, which are used to treat acute or chronic bronchial inflammation, will be permitted
- 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
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 |
|---|---|---|
| NP-101Also: TQ FormulaNP-101 is an organically derived, GMP manufactured product covered under IND #152687. | Drug | Active Drug Treatment |
| PlaceboIdentical placebo | Other | Placebo |
Primary outcome
Establishment of MTDD
Time frame: Fourteen days per dose (Phase IIA Only)
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold. This outcome measure ONLY APPLIES TO the Phase-IIa (Dose-finding) component of the trial.
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Time frame: Through Day 45
Evaluation of the number of overall adverse events, related adverse reactions, adverse events leading to discontinuation of study drug, hospitalization, or death.
Time to Sustained Clinical Recovery
Time frame: Through Day 5
This outcome measure ONLY APPLIES TO the Phase-IIb (efficacy) component of the trial per protocol. Therefore, the six arms of the Phase-IIa (dose-finding phase, three dose levels of NP-101 and placebo investigated) were not part of this data entry. This outcome measure is defined as the difference of Sustained Clinical Recovery (SCR) rates on Day 5 in patients taking the MTDD of NP-101 vs Placebo.
17 secondary outcomes
Difference of Change in Log2 of Viral Load From Baseline to Day-7 Between NP-101 and Placebo
Time frame: Enrollment to Day-7 on study
Difference of Change in ORF1 Gene From Baseline to Day-7 Between NP-101 and Placebo
Time frame: Enrollment to Day-7
Difference in Change of E-Gene From Baseline to Day-7 Between N101 and Placebo
Time frame: From Enrollment to Day-7
Differenc in Change of N-Gene From Baseline to Day-7 Between NP-101 and Placebo
Time frame: From enrollment to Day-7
RT-PCR Negative/Undetectable Rate at Day 7
Time frame: Days 0 to 7
RT-PCR Negative/Undetectable on Day-14
Time frame: Day 0 to Day-14
Median Time to Sustained Clinical Recovery
Time frame: From Day-0 to Day-28
Median Day to Complete Clinical Recovery
Time frame: From Day-0 to Day-28
Median Days to Complete Clinical Resolution
Time frame: From Day-0 to Day-28
Difference of the Change From Randomization to Day-7 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Time frame: From Day-0 to Day-7
Difference of the Change From Randomization to Day-7 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Time frame: From Day-0 to Day-7
Difference of the Change From Randomization to Day-7 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Time frame: From Day-0 to Day-7 Cell Percentages
Difference of the Change From Randomization to Day-14 of Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Time frame: From Day*0 to Day-14
Difference of the Change From Randomization to Day-14 ın the Ratio of the Absolute Counts of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Time frame: From Day-0 to Day-14
Difference of the Change From Randomization to Day-14 of Percentages of CD4+ and CD8+ Markers Between NP-101 and Placebo Arms.
Time frame: From Day-0 to Day-14
Proportion of Participants With Symptom Progression
Time frame: From Day-0 to Day28
Proportion of Paticipants With Long-Covid Symptoms
Time frame: Day-29 to Day-45
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
4 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 NP-101 in people with COVID-19, run by Novatek Pharmaceuticals at 4 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 26 inclusion and 14 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: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 13 Aug 2026). 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?
Establishment of MTDD (time frame: Fourteen days per dose (Phase IIA Only)). The study lists 3 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 13 Aug 2026.