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NP-101 for COVID-19 (BOSS-002 Trial)
Phase 2
Recruiting
Research Sponsored by Novatek Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 45
Awards & highlights
BOSS-002 Trial Summary
This trial will test the safety and effectiveness of a potential Covid-19 treatment for high risk patients. Participants will receive treatment and be compared to a control group to evaluate effects.
Who is the study for?
This trial is for adults over 18 with mild to moderate COVID-19 symptoms, diagnosed within the last 5 days. Participants must have high-risk factors like being over 60 or having certain chronic diseases. They should be able to take oral meds and follow study procedures, including effective contraception use.Check my eligibility
What is being tested?
The trial tests NP-101's safety and effectiveness against COVID-19 in high-risk patients, determining the highest dose they can tolerate without severe side effects. Patients will receive either NP-101 or a placebo twice daily for two weeks while their health outcomes are monitored.See study design
What are the potential side effects?
While specific side effects of NP-101 aren't listed here, common ones may include digestive issues due to its oral administration form and potential allergic reactions related to its ingredients such as black seed oil or thymoquinone.
BOSS-002 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fourteen days per dose (phase iia only)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fourteen days per dose (phase iia only)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establishment of MTDD
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Time to Sustained Clinical Recovery
BOSS-002 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Drug TreatmentExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
As above, except dosed with matching placebo capsules.
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Who is running the clinical trial?
Novatek PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying COVID-19
60 Patients Enrolled for COVID-19
Ahmed Kaseb, MDStudy DirectorNovatek Pharmaceuticals
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying COVID-19
60 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition like Crohn's disease that might affect how your body absorbs the study drug in capsule form.You have severe liver disease or very low levels of certain blood measurements.You have had moderate to severe chronic kidney disease at the time of joining the study.You have severe symptoms of Covid-19.You are currently taking certain medications that are processed by the CYP2C9 enzyme.Your oxygen level while resting is higher than 93% when breathing normal air.You are 18 years or older and have mild to moderate symptoms of Covid-19 that started within the last 5 days.You have been diagnosed with the flu in the past 14 days.You have tested positive for COVID-19 within the last 5 days before the trial starts.You have had allergic reactions to black seed oil or thymoquinone.You have moderate symptoms on the day of joining the study.You have not taken corticosteroid pills or injections in the last 4 weeks, but using inhaled steroids for asthma is okay.You have uncontrolled HIV, Hepatitis B, or Hepatitis C infection.If you are at high risk, you have at least one of these conditions: being 60 years or older, active cancer, chronic kidney disease, chronic lung disease (like COPD), obesity (having a BMI of 30 or more), serious heart conditions, diabetes (type 1 or type 2), a weakened immune system, chronic liver disease, cystic fibrosis, HIV infection, smoking (current or former), sickle cell disease or thalassemia, having had a solid organ or blood stem cell transplant, or a history of stroke or cerebrovascular disease.
Research Study Groups:
This trial has the following groups:- Group 1: Active Drug Treatment
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the enrollment for this clinical trial progressing?
"Affirmative, the clinicaltrials.gov platform has information indicating that this trial is seeking enrolment of 308 participants at 1 location. The study was first advertised on February 22nd 2023, and recently updated on March 23rd 2023."
Answered by AI
To what extent can Active Drug Treatment be detrimental to individuals?
"Our team at Power considers Active Drug Treatment to be moderately safe, giving it a score of 2 on our scale due to Phase 2 clinical trial data showing some proof of safety but none for efficacy."
Answered by AI
Is enrollment to this research still possible?
"Clinicialtrials.gov reveals that the study is presently recruiting subjects, with its initial posting on February 22nd 2023 and most recent update happening on March 23rd 2023."
Answered by AI
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