What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral drugs like remdesivir, corticosteroids like dexamethasone, and monoclonal antibodies. Known side effects of these treatments can vary. Remdesivir may cause nausea, elevated liver enzymes, and allergic reactions. Dexamethasone can lead to hyperglycemia, increased risk of infections, and gastrointestinal bleeding. Monoclonal antibodies might cause infusion-related reactions, including fever, chills, and low blood pressure. It is important to monitor patients for these side effects and manage them appropriately.

What prior FDA approvals exist?

Remdesivir is one of the primary drugs that has received FDA approval for the treatment of COVID-19. It is an antiviral medication that inhibits RNA-dependent RNA polymerase, which is essential for viral replication. This mechanism is somewhat related to the investigational drug NP-101, which is being studied for its safety, tolerability, and efficacy in treating high-risk COVID-19 patients. While the exact mechanism of NP-101 is not detailed, it is likely targeting similar pathways involved in viral replication or immune response modulation.

What other types of research exist?

Promising novel alternatives to NP-101 for treating COVID-19 include: 1. Antiviral drugs like Remdesivir, which inhibits viral RNA polymerase. 2. Immunomodulatory drugs such as Dexamethasone, which reduces inflammation by modulating the immune response. 3. Monoclonal antibodies like Sotrovimab, which target the spike protein of SARS-CoV-2 to neutralize the virus. 4. Antiviral peptides and molecules identified through in-silico methods and synthetic approaches. 5. Drugs targeting macrophage recruitment and cytokine storm, such as those modulating interferon signaling. These alternatives are in various stages of clinical trials and have shown potential in improving clinical outcomes for COVID-19 patients.

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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

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and fourteen days per dose (phase iia only) for reporting.

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.

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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.