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Blood Clot Prevention Therapies for COVID-19 (ACTIV-4A Trial)
ACTIV-4A Trial Summary
This trial is testing different ways to prevent blood clots in people who have COVID-19.
ACTIV-4A Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACTIV-4A Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ACTIV-4A Trial Design
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Who is running the clinical trial?
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- Criterion: Two or more of the following -You are expected to pass away very soon.I am over 65 or have at least two of the listed health conditions.If you are moderately ill, you need to have one or more of these risk factors.I am in the ICU receiving critical care treatments.I have a history of Type 2 diabetes.I need more than 2 liters of oxygen per minute.I am currently taking an SGLT2 inhibitor medication.I don't have severe anemia or any condition that prevents me from taking crizanlizumab.This criterion means "two or more of the following."I have a history of heart failure.You are likely to need to stay in the hospital for more than 72 hours.I am 18 years old or older.I am currently hospitalized due to COVID-19.I have been treated with crizanlizumab in the last 3 months.I needed a machine to help me breathe through a tube in my neck before I was hospitalized.I am hospitalized but not in the ICU or on advanced support like ventilators or ECMO.
- Group 1: Therapeutic Dose Anticoagulation
- Group 2: Prophylactic Dose Anticoagulation + P2Y12 inhibitor
- Group 3: Therapeutic Dose Anticoagulation + P2Y12 inhibitor
- Group 4: Standard of Care + SGLT2 inhibitor
- Group 5: Prophylactic Dose Anticoagulation
- Group 6: Standard of Care + Crizanlizumab
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
To what extent has this particular treatment been evaluated in other scientific studies?
"Initial research on this therapeutic intervention was conducted in 2006, and 1332 investigations have completed since then. At present, 268 studies are still active with a significant portion of those taking place in Jackson, Mississippi."
Is this research a groundbreaking endeavor?
"Since 2006, there has been significant research into this particular treatment. Initial investigation was conducted by Ash Access Technology with a clinical trial of 415 patients in the same year. This eventually led to its Phase 3 approval and currently, it is being studied across 937 cities and 75 countries via 268 active trials."
What is the aggregate number of participants in this investigation?
"3000 individual volunteers, who comply with the inclusionary standards, are required to partake in this trial. Participants can take part from a variety of sites such as University of Mississippi Medical Center in Jackson and Mercy Health St Vincent Medical Centre in Toledo."
At which locations is this experiment currently taking place?
"This research endeavour is accepting patients from the University of Mississippi Medical Center in Jackson, Mercy Health St Vincent Medical Center in Toledo, and Temple University in Philadelphia. A further 80 sites are also participating."
Are individuals able to submit applications for this research trial at present?
"The clinicaltrials.gov portal states that the trial is in its recruitment phase, beginning on September 4th 2020 and last updated at the end of September 2022."
Has the FDA sanctioned this treatment regimen?
"There is a plentiful amount of evidence proving the safety of this therapy, so it was given an impressive score of 3."
To what health issues is this intervention commonly applied?
"This particular treatment is commonly used to prevent peripheral arterial embolism, however its efficacy can also extend to myocardial infarction, post-surgery recovery and medical device implantation."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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