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Monoclonal Antibodies

Blood Clot Prevention Therapies for COVID-19 (ACTIV-4A Trial)

Phase 4

Waitlist Available

Led By Mikhail Kosiborod, MD

Research Sponsored by Matthew Neal MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For moderate illness severity, participants are required to meet one or more of the following risk criteria: Age ≥ 65 years or ≥2 of the following - O2 supplementation > 2 liters per minute, BMI ≥ 35, GFR ≤ 60, History of Type 2 diabetes, History of heart failure (regardless of ejection fraction), D dimer ≥ 2x the site's upper limit of normal (ULN), Troponin ≥ 2x the site's ULN, BNP≥100 pg/mL or NT-proBNP≥300 pg/mL, CRP ≥50 mg/L

Severe illness severity - defined as ICU level of care at the time of randomization (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days from enrollment

Awards & highlights

ACTIV-4A Trial Summary

This trial is testing different ways to prevent blood clots in people who have COVID-19.

Who is the study for?

This trial is for hospitalized COVID-19 patients aged 18 or older with Type 2 diabetes, heart failure, severe illness requiring ICU care, or moderate illness with additional risk factors like oxygen needs over 2 liters per minute. Patients must be enrolled within 72 hours of hospital admission or positive COVID test and expected to stay in the hospital for more than 72 hours.Check my eligibility

What is being tested?

The study compares antithrombotic strategies (like heparin) and other treatments (such as SGLT2 inhibitors and Crizanlizumab Injection) to prevent adverse outcomes in COVID-19 inpatients. It's a randomized trial where patients are assigned different treatments by chance.See study design

What are the potential side effects?

Potential side effects may include bleeding risks from antithrombotic agents like heparin, possible kidney issues from SGLT2 inhibitors, and reactions such as anemia or uncontrolled bleeding related to Crizanlizumab.

ACTIV-4A Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 65 or have at least two of the listed health conditions.

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I am in the ICU receiving critical care treatments.

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I have a history of Type 2 diabetes.

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I need more than 2 liters of oxygen per minute.

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I have a history of heart failure.

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I am 18 years old or older.

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I am currently hospitalized due to COVID-19.

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I am hospitalized but not in the ICU or on advanced support like ventilators or ECMO.

ACTIV-4A Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days from enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days from enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

21 Day Organ Support (respiratory or vasopressor) Free Days

Secondary outcome measures

Acute kidney injury

Days free of death

Death Composite

+2 more

Other outcome measures

Primary Safety Endpoint of Major Bleeding

Secondary Safety Endpoint of HIT

ACTIV-4A Trial Design

6Treatment groups

Experimental Treatment

Group I: Therapeutic Dose Anticoagulation + P2Y12 inhibitorExperimental Treatment2 Interventions

increased dose of heparin above standard of care with an added P2Y12 inhibitor This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)

Group II: Therapeutic Dose AnticoagulationExperimental Treatment1 Intervention

increased dose of heparin above standard of care. 1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.

Group III: Standard of Care + SGLT2 inhibitorExperimental Treatment1 Intervention

Standard of care plus SGLT2 inhibitor This arm will enroll moderate and severe illness patients This arm was ended in March 2023

Group IV: Standard of Care + CrizanlizumabExperimental Treatment1 Intervention

Standard of care plus crizanlizumab infusion This arm will enroll moderate and severe illness patients This arm was ended for all patients per the DSMB in September 2022.

Group V: Prophylactic Dose Anticoagulation + P2Y12 inhibitorExperimental Treatment2 Interventions

Heparin standard of care with an added P2Y12 inhibitor This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.

Group VI: Prophylactic Dose AnticoagulationExperimental Treatment1 Intervention

Heparin standard of care 1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SGLT2 inhibitor

2019

Completed Phase 3

~17850

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Matthew Neal MDLead Sponsor

3 Previous Clinical Trials

404 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,841 Previous Clinical Trials

47,810,866 Total Patients Enrolled

Mikhail Kosiborod, MDPrincipal InvestigatorSaint Lukes

4 Previous Clinical Trials

1,902 Total Patients Enrolled

Media Library

Crizanlizumab Injection (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04505774 — Phase 4

Coronavirus Research Study Groups: Prophylactic Dose Anticoagulation + P2Y12 inhibitor, Therapeutic Dose Anticoagulation + P2Y12 inhibitor, Therapeutic Dose Anticoagulation, Standard of Care + SGLT2 inhibitor, Prophylactic Dose Anticoagulation, Standard of Care + Crizanlizumab

Coronavirus Clinical Trial 2023: Crizanlizumab Injection Highlights & Side Effects. Trial Name: NCT04505774 — Phase 4

Crizanlizumab Injection (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505774 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

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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."

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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."

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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."

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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."

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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."

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