What side effects are associated with this type of intervention?

Common treatments for COVID-19 that modulate the host tissue response include tocilizumab and other immune modulators. Tocilizumab, an IL-6 pathway inhibitor, can cause side effects such as constipation, diarrhea, nausea, anxiety, insomnia, hypertension, and superinfection. It should be used cautiously in immunocompromised individuals and requires deferral of live vaccines for at least two weeks post-treatment. Other immune modulators are used on a case-by-case basis due to uncertain benefits and risks.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19 that aim to modulate the body's response to the virus. One notable example is the use of IL-6 pathway inhibitors like tocilizumab, which can reduce inflammation and potentially improve clinical outcomes in severe cases. Additionally, monoclonal antibodies such as bebtelovimab were authorized for use against specific SARS-CoV-2 variants, although their efficacy varies with different strains. These treatments focus on modulating the immune response to prevent progression to severe disease, aligning with the goals of host tissue response modulators.

What other types of research exist?

Promising novel alternatives to Host Tissue Response Modulators for COVID-19 treatment in 2024 include: 1) Specific antiviral therapies that target the virus directly, 2) Immune modulators that reduce inflammatory damage, 3) Nutritional supplements like quercetin, which have shown potential in preclinical studies, and 4) Biomaterials-based strategies to engineer the pulmonary immune response and prevent systemic complications.

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Experimental COVID-19 Therapies for COVID-19 (NECTAR Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

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 day 1 to hospital discharge or day 90 whichever comes first

Summary

This trial is testing medicines to help hospitalized COVID-19 patients with low oxygen levels. The goal is to improve how their bodies respond to the virus, speeding up recovery and preventing severe illness.

Who is the study for?

Adults hospitalized with COVID-19 showing symptoms like fever, cough, chest pain, or shortness of breath and needing oxygen support. Not eligible if they've been in certain other drug trials recently, have severe liver issues, are pregnant/breastfeeding, have end-stage kidney disease on dialysis or specific allergies to trial drugs.

What is being tested?

The study is testing whether Fostamatinib, TXA127, TRV027 or a placebo can help patients recover faster from COVID-19 and prevent serious complications. Patients will be randomly assigned to one of these treatments to compare their effectiveness.

What are the potential side effects?

Possible side effects may include allergic reactions for those sensitive to the medications being tested. Specific side effects for each drug aren't listed but could range from mild (like headaches) to severe (affecting organs).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to hospital discharge or day 90 whichever comes first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to hospital discharge or day 90 whichever comes first

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to hospital discharge or day 90 whichever comes first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oxygen

Secondary study objectives

28-day mortality

60-day mortality

90-day mortality

+10 more

Other study objectives

Allergic reaction

Changes in NT-proBNP (when possible, at participating sites)

Hypotension

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: TXA127 (4/20/2022 Arm Closed to Accrual)Experimental Treatment1 Intervention

An investigational peptide agonist of Mas receptors.

Group II: TRV027 (4/20/2022 Arm Closed to Accrual)Experimental Treatment1 Intervention

An investigational peptide biased agonist of the AT1 receptor.

Group III: FostamatinibExperimental Treatment1 Intervention

An investigational oral spleen tyrosine kinase inhibitor.

Group IV: PlaceboPlacebo Group1 Intervention

NaCl 0.9% infused to match the duration of the agent for TXA127, TRV027, and APN01. Orange film-coated, plain, bioconvex tablets for fostamatinib. For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TXA127

2021

Completed Phase 3

~950

TRV027

2020

Completed Phase 3

~900

Fostamatinib

2021

Completed Phase 3

~1520

Do I qualify?Apply below to find out

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 that modulate the host tissue response include corticosteroids like dexamethasone, which reduce inflammation by suppressing the immune system, and monoclonal antibodies such as tocilizumab, which inhibit specific inflammatory pathways like the IL-6 receptor. These treatments are crucial for COVID-19 patients as they help to prevent the progression to severe disease by controlling the hyperinflammatory state often seen in critical cases. By modulating the body's response to the virus, these therapies aim to reduce complications, hasten recovery, and improve overall clinical outcomes.

Therapeutic mechanism of Toujie Quwen granules in COVID-19 based on network pharmacology.