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Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive. (BOSS-002)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NP-101
Placebo
Sponsored by
Novatek Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, High Risk, Outpatient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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)

Sites / Locations

  • L&A Morales Healthcare/ Enrique Villa, MD Principal InvestigatorRecruiting
  • Research Network AmericaRecruiting
  • Clinical Trial NetworkRecruiting
  • Pearland Family Wellness ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Drug Treatment

Placebo

Arm Description

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.

As above, except dosed with matching placebo capsules.

Outcomes

Primary Outcome Measures

Establishment of MTDD
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold
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 d/c of study drug and hospitalizations or death.
Time to Sustained Clinical Recovery
Measurement of the difference of SCR rates on Day 5 in patients taking the MTDD of NP-101 vs Placebo.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2023
Last Updated
June 19, 2023
Sponsor
Novatek Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05785390
Brief Title
Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.
Acronym
BOSS-002
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
October 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novatek Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, High Risk, Outpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase IIb will be a 2 parallel arms, double - blind, randomized, placebo controlled study
Masking
ParticipantInvestigator
Masking Description
Participant, Investigator will all be blinded.
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Drug Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
As above, except dosed with matching placebo capsules.
Intervention Type
Drug
Intervention Name(s)
NP-101
Other Intervention Name(s)
TQ Formula
Intervention Description
NP-101 is an organically derived, GMP manufactured product covered under IND #152687.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Identical placebo
Primary Outcome Measure Information:
Title
Establishment of MTDD
Description
Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold
Time Frame
Fourteen days per dose (Phase IIA Only)
Title
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Description
Evaluation of the number of overall adverse events, related adverse reactions, adverse events leading to d/c of study drug and hospitalizations or death.
Time Frame
Through Day 45
Title
Time to Sustained Clinical Recovery
Description
Measurement of the difference of SCR rates on Day 5 in patients taking the MTDD of NP-101 vs Placebo.
Time Frame
Through Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Kaseb, MD
Phone
1-877-662-8351
Email
akaseb@novatekpharmaceuticals.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Y Gocio, BA
Phone
1-877-662-8351
Email
mgocio@novatekpharmaceuticals.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Kaseb, MD
Organizational Affiliation
Novatek Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
L&A Morales Healthcare/ Enrique Villa, MD Principal Investigator
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anya Gutierrez
Phone
786-360-1458
Email
agutierrez@moraleshealthcare.com
Facility Name
Research Network America
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Mellacheruvu
Phone
708-637-4066
Email
smellacheruvu@researchnetworkamerica.com
First Name & Middle Initial & Last Name & Degree
Rathna K Yallapragada, MD
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janak Lamichhane
Phone
713-484-6947
Email
jlamichhane@ctntexas.com
First Name & Middle Initial & Last Name & Degree
Susan Vogel, MD
Facility Name
Pearland Family Wellness Clinic
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Martinez
Phone
855-877-5977
Email
mmartinez@pfwcclinic.com
First Name & Middle Initial & Last Name & Degree
Enas Kaseb, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.

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