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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
Study Summary
This trial aims to see if adding a drug to standard care for COVID-19 patients on low flow oxygen can help improve their recovery.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Days to Recovery Scale
Secondary outcome measures
Three-category ordinal outcome
all-cause mortality though Day 60
the pulmonary ordinal outcome
+2 moreSide effects data
From 2016 Phase 4 trial • 3 Patients • NCT0207819367%
COPD exacerbation
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,587,475 Total Patients Enrolled
James Neaton, PhDStudy ChairUniversity of Minnesota
7 Previous Clinical Trials
22,993 Total Patients Enrolled
Cavan Reilly, PhDStudy ChairUniversity of Minnesota
3 Previous Clinical Trials
3,320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I was hospitalized for COVID-19 treatment.I started using extra oxygen for COVID-19 within the last 5 days.I need a high level of oxygen support.I am on medication that affects my immune system.My doctor thinks my organs are too weak for this trial.I have not had a live vaccine in the last 3 months and do not plan to get one during the trial.I am taking or will take an IM drug for COVID-19 treatment before joining the study.I don't have a serious infection that could risk my health with new treatments.I am taking or might need drugs that affect my immune system for my condition.I have COVID-19 pneumonia and need a certain amount of oxygen.
Research Study Groups:
This trial has the following groups:- Group 1: active treatment group
- Group 2: Control group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the active treatment group in this study been validated by the FDA?
"The active treatment group has been granted a security rating of 3 due to its Phase 4 trial status, which indicates the drug's official approval."
Answered by AI
Are participants still being accepted for this research study?
"As per clinicaltrials.gov, this medical study is not currently accepting patients, although it was posted on June 1st 2023 and last updated April 18th 2023. Fortunately there are 1080 other trials actively recruiting participants at the moment."
Answered by AI
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