Abatacept Infusion for COVID-19

No longer recruiting at 145 trial locations

Overseen By Cavan Reilly, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must be taking: Corticosteroids, Baricitinib

Must not be taking: Abatacept, Chemotherapy

Disqualifiers: Advanced HIV, Pregnancy, Tuberculosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 60 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether an infusion of abatacept, a medication that adjusts the immune system, can improve recovery in hospitalized COVID-19 patients. The focus is on patients receiving low-flow oxygen, aiming to determine if adding abatacept to standard care speeds up recovery compared to standard care alone. People with confirmed COVID-19 who are hospitalized and require low-flow oxygen might be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, offering a chance to contribute to broader knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain immune-modulating drugs, you may need to discuss this with the trial team, as some exclusions apply.

What is the safety track record for abatacept?

A previous study showed that abatacept helped patients hospitalized with severe COVID-19. Importantly, safety results for those taking abatacept matched those taking a placebo, with no major differences in side effects or infections between the groups. Additionally, abatacept is already approved for other conditions, so its safety is well understood. This information may reassure those considering joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for COVID-19, which often include antivirals and corticosteroids, abatacept works by targeting the immune response. Abatacept is unique because it modulates the activity of T-cells, a type of immune cell, to prevent an overactive immune response that can lead to severe inflammation and complications. Researchers are excited about this approach because it offers a novel way to control the body's reaction to the virus, potentially reducing severe symptoms and improving recovery outcomes.

What evidence suggests that abatacept might be an effective treatment for COVID-19?

In this trial, participants will join one of two groups: an active treatment group receiving abatacept or a control group receiving a placebo. Research has shown that abatacept is effective in patients with severe COVID-19. In one study, patients who received abatacept demonstrated good recovery results. This drug reduces inflammation, a common issue in COVID-19 cases. However, some patients might require higher doses for optimal results. Abatacept is already used to treat conditions like psoriatic arthritis, where it helps control the immune system, supporting its potential use in managing severe COVID-19. ^{1 2 6 7 8}

Who Is on the Research Team?

Cavan Reilly, PhD

Principal Investigator

University of Minnesota

Christina Barkauskas, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was hospitalized for COVID-19 treatment.

I started using extra oxygen for COVID-19 within the last 5 days.

Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test within 14 days of randomization

Exclusion Criteria

I have received more than one IM injection for COVID-19 before joining this trial.

I have advanced HIV and am not on HIV medication.

I have or might have untreated tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IV abatacept infusion or placebo combined with standard of care to improve recovery from COVID-19

60 days

Multiple visits as required for treatment and monitoring

Follow-up

Participants are monitored for sustained recovery, pulmonary outcomes, and all-cause mortality

60 days

Follow-up visits with participant or proxy, chart review

What Are the Treatments Tested in This Trial?

Interventions

• abatacept
• Abatacept
• Placebo
• Placebo group

Trial Overview 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.

How Is the Trial Designed?

Group I: active treatment group Experimental Treatment 1 Intervention

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

Group II: Control group Placebo Group 1 Intervention

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

abatacept is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in United States as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in Canada as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in Japan as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in Switzerland as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Abatacept (Orencia) significantly improves symptoms of active rheumatoid arthritis and slows joint damage progression in patients who have previously been treated with other therapies, based on results from two phase III trials involving multiple centers over 6 to 12 months.

The treatment is generally well tolerated, with similar rates of serious adverse events between abatacept and placebo, although it may be less well tolerated when combined with other biologic DMARDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abatacept. Hervey, PS., Keam, SJ.[2018]

The study found that 60% of rheumatoid arthritis patients were aware of the patient alert cards (PACs) for abatacept, and those who received the PACs had significantly better knowledge about the risk of infections compared to those who did not (64% vs 46%).

Among healthcare professionals, 90% were aware of the PACs, and those who accessed the cards had a higher understanding of infection risks (91% vs 73%), indicating that PACs effectively enhance safety knowledge for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking process indicators and clinical/safety outcomes to assess the effectiveness of abatacept (ORENCIA) patient alert cards in patients with rheumatoid arthritis. Artime, E., Kahlon, R., Méndez, I., et al.[2021]

Abatacept pharmacokinetics in rheumatoid arthritis patients can be effectively modeled using a linear 2-compartment model, with body weight being the key factor influencing drug clearance and distribution.

The study found that maintaining a steady-state trough concentration (Cminss) of abatacept at or above 10 μg/mL is crucial for achieving optimal efficacy, as higher concentrations correlate with better disease activity scores and response rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Relationship of Intravenous and Subcutaneous Abatacept in Patients With Rheumatoid Arthritis. Li, X., Roy, A., Murthy, B.[2020]

Abatacept significantly improves health outcomes in patients with rheumatoid arthritis, showing higher likelihoods of achieving American College of Rheumatology (ACR) response rates compared to placebo and other treatments, based on a meta-analysis of 13 randomized control trials involving 5978 patients.

Patients treated with abatacept experienced fewer adverse events compared to those receiving other biologic disease-modifying anti-rheumatic drugs, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of efficacy and safety of abatacept for rheumatoid arthritis: systematic review and meta-analysis. Mohamed Ahamada, M., Wu, X.[2023]

In a study of 51 patients with rheumatoid arthritis, switching from intravenous (IV) abatacept to subcutaneous (SC) abatacept resulted in a 27% relapse rate, indicating some patients may not respond adequately to the SC formulation.

When patients who relapsed were switched back to IV abatacept, their disease activity decreased, suggesting that IV administration may be more effective for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching from intravenous to subcutaneous formulation of abatacept: a single-center Italian experience on efficacy and safety. Reggia, R., Franceschini, F., Tincani, A., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11046337/

Abatacept Pharmacokinetics and Exposure Response in ... In this study, abatacept was shown to be efficacious in patients hospitalized with severe COVID-19, although some patients may require higher dosing.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10445680/

Diminished responses to mRNA-based SARS-CoV-2 vaccines ... Although both vaccines showed approximately 95% efficacy at preventing COVID-19 ... Thus, abatacept treatment limits the efficacy of SARS-CoV-2 mRNA vaccines in ...

3. cidrap.umn.edu cidrap.umn.edu/covid-19/study-reveals-promising-results-abatacept-severe-covid

Study reveals promising results for abatacept for severe ... A new study shows good results in patients with severe COVID-19 for abatacept, an anti-inflammatory immunomodulating drug used to treat psoriatic arthritis.

4. healio.com healio.com/news/rheumatology/20231219/holding-abatacept-tnfi-unnecessary-for-receiving-covid19-booster

Holding abatacept, TNFi unnecessary for receiving COVID ... COVID-19 vaccine boosters led to a significantly increased antibody response in patients using abatacept or TNF inhibitors regardless of whether they held ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S120197122400239X

Efficacy of infliximab, abatacept, and cenicriviroc for the ... We demonstrated that infliximab accelerated improvement and reduced deterioration of clinical status when added to standard of care.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37428480/

Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults ... Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies. Conclusions and ...

7. news.bms.com news.bms.com/news/details/2022/Bristol-Myers-Squibb-Announces-Topline-Results-Showing-Treatment-with-Orencia-abatacept-Improved-Survival-in-People-Hospitalized-with-COVID-19/default.aspx

Corporate news details Bristol Myers Squibb Announces Topline Results Showing Treatment with Orencia (abatacept) Improved Survival in People Hospitalized with COVID-19.

8. becarispublishing.com becarispublishing.com/doi/10.57264/cer-2023-0144

Real-world clinical outcomes and rationale for initiating ... This retrospective cohort study aimed to describe changes in Clinical Disease Activity Index (CDAI) measures over 12 months among patients with ...