General public

What is ACTIV-4a?

Many patients hospitalized with COVID-19 develop blood clots and signs of coagulation in multiple organs in autopsy findings. These signs of increase coagulation correlate with worse organ failure and mortality. The ACTIV-4a is a multi-center clinical trial looking at agents that decreases coagulation of the blood in patients hospitalized for COVID-19.

Who can be in this study?

Adults (age 18 and older) admitted to the hospital with symptomatic COVID-19 infection within 3 days of infection or presentation.

What Happens in this study?

• A random half of the patients in the study will receive an agent that decreased clots blood coagulation while the other half will be treated as usual by their doctors. This will continue for 14 days or until the patient leaves the hospital, whichever comes first
• Information will be collected from study participants’ medical records and by phone calls after they leave the hospital at about 3 months and 1-year
• Some additional blood tests may be performed

Who is paying for this study?

The National Institutes of Health (NIH), which is part of the U.S. government, is paying for this research.

Trial Summary:

Purpose:

ACTIV-4A aims to determine the effectiveness of antithrombotic strategies for prevention of adverse outcomes and organ failure in COVID-19 positive inpatients. Different anti-thrombotic agents will be evaluated including anticoagulation like heparin or anti-platelet agents like P2Y12 inhibitors.

Study Design:

ACTIV-4A is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients.

Primary Objectives

To determine the most effective antithrombotic strategy for increasing the number of days free of organ support and reducing death.

Secondary Objectives

• To determine the most effective antithrombotic strategy on the composite endpoint of death, deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), ischemic stroke, or other systemic arterial thrombosis (AT).
• To assess the safety of antithrombotic strategies through the endpoint of major bleeding as defined by the International Society on Thrombosis and Hemostasis.
• To compare the effect of antithrombotic strategies on the endpoint of all-cause mortality in the study population.

Study Size:

Sample size will depend on the agent being tested, event rate and probability of benefit of the agent being investigated.