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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
Summary
This trial is testing NP-101, a new treatment for high-risk Covid-19 patients. It aims to find the safest and most effective dose by comparing different amounts of the treatment. Participants will receive either NP-101 or another form of care, along with the best supportive care.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Establishment of MTDD
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)
Time to Sustained Clinical Recovery
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for COVID-19 include antiviral drugs, anti-inflammatory agents, and supportive therapies. Antiviral drugs, such as remdesivir, work by inhibiting the replication of the virus, thereby reducing viral load.
Anti-inflammatory agents, like dexamethasone, help to mitigate the severe inflammatory response often seen in COVID-19, which can lead to complications such as acute respiratory distress syndrome (ARDS). Supportive therapies, including oxygen and mechanical ventilation, assist in maintaining adequate oxygenation in patients with severe respiratory symptoms.
Understanding these mechanisms is crucial as it helps in tailoring treatments to individual patient needs and in developing new therapies, such as NP-101, which aim to improve outcomes by targeting specific aspects of the disease process.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.A brief review of the latest pharmacological treatments of COVID-19.Pulmonary vasodilators: beyond the bounds of pulmonary arterial hypertension therapy in COVID-19.
A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.A brief review of the latest pharmacological treatments of COVID-19.Pulmonary vasodilators: beyond the bounds of pulmonary arterial hypertension therapy in COVID-19.
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Who is running the clinical trial?
Novatek PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
Ahmed Kaseb, MDStudy DirectorNovatek Pharmaceuticals
1 Previous Clinical Trials
55 Total Patients Enrolled
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.
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