What side effects are associated with this type of intervention?

Common treatments for COVID-19 involving immune modulation include drugs like glucocorticoids (e.g., dexamethasone), interleukin-6 inhibitors (e.g., tocilizumab), and other immunomodulatory agents. Known side effects of these treatments can include increased risk of infections, gastrointestinal symptoms, and potential for adverse effects related to immune suppression. For example, tocilizumab has been associated with infections and elevated liver enzymes. Glucocorticoids can cause hyperglycemia, hypertension, and increased susceptibility to infections.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including remdesivir, which decreases viral replication and speeds recovery, and tocilizumab, which improves mortality by preventing severe cytokine storms. Tocilizumab, an IL-6 antagonist, is particularly relevant as it modulates the immune response, similar to the investigational use of Abatacept in the STRIVE trial. These treatments aim to manage the dysregulated immune response triggered by COVID-19, improving outcomes in hospitalized patients.

What other types of research exist?

Promising novel alternatives to Abatacept for immune modulation in COVID-19 patients include tocilizumab and baricitinib. Tocilizumab and baricitinib have shown potential in improving mortality by preventing severe cytokine storms. Additionally, convalescent plasma and humanized monoclonal antibodies offer passive immunity and decreased recovery time.

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Immunomodulator

Abatacept Infusion for COVID-19

Phase 4

Recruiting

Led By Jens Lundgren, PhD

Research Sponsored by University of Minnesota

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 5, 14, and 28

Awards & highlights

Summary

This trial tests if using abatacept with usual treatment helps hospitalized COVID-19 patients recover better by calming their immune system.

Who is the study for?

This trial is for hospitalized COVID-19 patients who recently started low flow oxygen therapy and are already taking an immune modulator like corticosteroids. They must have evidence of pneumonia caused by COVID-19 but not be on high levels of oxygen support or other advanced respiratory assistance. Excluded are those with severe immune deficiencies, active serious infections, certain blood disorders, recent live vaccines, pregnancy, breastfeeding, or specific treatments that could interfere with the study.

What is being tested?

The STRIVE trial is testing if adding abatacept (an immune system regulator) to standard care helps recovery better than a placebo in early-stage hospitalized COVID-19 patients on low flow oxygen. The goal is to see if intensifying immune modulation before the disease worsens improves outcomes.

What are the potential side effects?

Abatacept may cause side effects such as increased risk of infections due to its effect on the immune system, possible allergic reactions at the infusion site, headache, nausea and potential worsening of underlying conditions that involve the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 5, 14, and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 5, 14, and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 5, 14, and 28 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Days to Recovery Scale

Secondary study objectives

Three-category ordinal outcome

all-cause mortality though Day 60

the pulmonary ordinal outcome

+2 more

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193

67%

COPD exacerbation

100%

80%

60%

40%

20%

Study treatment Arm

Belatacept

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active treatment groupExperimental Treatment1 Intervention

Active treatment group (IV abatacept infusion, 10 mg/kg up to 1750 mg) + baseline IM

Group II: Control groupPlacebo Group1 Intervention

Placebo group (IV infusion of normal saline) + baseline IM

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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, such as abatacept, work by modulating the immune response. Abatacept targets specific pathways to reduce excessive inflammation caused by the virus, which can lead to severe tissue damage. By controlling this dysregulated immune response, these treatments aim to improve patient recovery and prevent the progression of the disease. This is crucial for COVID-19 patients as it helps manage severe symptoms and reduces the risk of complications, ultimately improving outcomes.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.Traditional Chinese medicine network pharmacology study on exploring the mechanism of Xuebijing Injection in the treatment of coronavirus disease 2019.