1500 Participants Needed

Abatacept Infusion for COVID-19

Recruiting at 133 trial locations
RS
CR
Overseen ByCavan Reilly, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Minnesota
Must be taking: Corticosteroids, Baricitinib
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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.

How does the drug abatacept differ from other COVID-19 treatments?

Abatacept is unique because it is a biologic drug that modulates the immune system by inhibiting T cell activation, which is different from many COVID-19 treatments that focus on antiviral effects. It is administered through infusion, which is less common for COVID-19 therapies that are often oral or injectable.12345

What data supports the effectiveness of the drug abatacept for treating COVID-19?

Abatacept has been shown to be effective in reducing pain and joint inflammation in patients with rheumatoid arthritis by modulating immune system activity. This suggests it might help manage inflammation in COVID-19, although direct evidence for COVID-19 is not provided.12345

Who Is on the Research Team?

CR

Cavan Reilly, PhD

Principal Investigator

University of Minnesota

CB

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
See 3 more

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.
See 14 more

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?
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

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

Find a Clinic Near You

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

Citations

Analysis of efficacy and safety of abatacept for rheumatoid arthritis: systematic review and meta-analysis. [2023]
Abatacept. [2018]
Linking process indicators and clinical/safety outcomes to assess the effectiveness of abatacept (ORENCIA) patient alert cards in patients with rheumatoid arthritis. [2021]
Population Pharmacokinetics and Exposure-Response Relationship of Intravenous and Subcutaneous Abatacept in Patients With Rheumatoid Arthritis. [2020]
Switching from intravenous to subcutaneous formulation of abatacept: a single-center Italian experience on efficacy and safety. [2015]
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