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

COVID-19 Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785390
• Other study ID #: BOSS-Covid-19-002
• Status: Recruiting
• Phase: Phase 2
• Start date: February 22, 2023
• Est. completion date: October 22, 2024

Study information

• Verified date: March 2023
• Source: Novatek Pharmaceuticals
• Contact: Ahmed Kaseb, MD
• Phone: 1-877-662-8351
• Email: akaseb[@]novatekpharmaceuticals.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: October 22, 2024
• Est. primary completion date: October 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• NP-101
NP-101 is an organically derived, GMP manufactured product covered under IND #152687.

Other:
• Placebo
Identical placebo

Locations

Country	Name	City	State
United States	Research Network America	Berwyn	Illinois
United States	Clinical Trial Network	Houston	Texas
United States	L&A Morales Healthcare/ Enrique Villa, MD Principal Investigator	Miami	Florida
United States	Pearland Family Wellness Clinic	Pearland	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novatek Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of MTDD	Number of DLTS (Dose Limiting Toxicities) in the NP-101 arm at each dose compared to placebo and the safety threshold	Fourteen days per dose (Phase IIA Only)
Primary	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.	Through Day 45
Primary	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.	Through Day 5