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

NCT05785390 | Terminated Phase 2 FDA Drug

• 1 other identifier: BOSS-Covid-19-002
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 4

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 \[insert effects\].

Conditions

COVID-19

Keywords

COVID-19; High Risk; Outpatient

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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

Study Arms (2)

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.

Drug: NP-101

Placebo

PLACEBO COMPARATOR

As above, except dosed with matching placebo capsules.

Other: Placebo

Interventions

NP-101 DRUG

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

Also known as: TQ Formula

Active Drug Treatment

Placebo OTHER

Identical placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novatek Pharmaceuticals: lead

Study Sites (4)

L&A Morales Healthcare/ Enrique Villa, MD Principal Investigator

Miami, Florida, 33142, United States

Location

Research Network America

Berwyn, Illinois, 60402, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Pearland Family Wellness Clinic

Pearland, Texas, 77584, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ahmed Kaseb, MD

  Novatek Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant, Investigator will all be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase IIb will be a 2 parallel arms, double - blind, randomized, placebo controlled study

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: March 27, 2023
• Study Start: February 22, 2023
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)