General public

What is ACTIV-3?

In response to the global COVID-19 pandemic, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private initiative was organized by NIH and the Foundation for the NIH (FNIH). ACTIV developed an international strategy for an integrated research response to COVID-19.

ACTIV-3 is a collaboration of INSIGHT and four other research networks: AIDS Clinical Trials Group (ACTG), Cardiothoracic Surgical Trials Network (CTSN), Prevention and Early Treatment of Acute Lung Injury (PETAL) and the US Department of Veterans Affairs (VA).

ACTIV-3 is designed to evaluate the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection.

Who can be in this study?

COVID-positive adults admitted to the hospital who have had symptoms (fever, cough, or trouble breathing, etc) for ≤ 12 days may be eligible for this study. Only hospitals that are part of the [INSIGHT Network] (https://insight.ccbr.umn.edu/index.php) and registered for TICO recruitment can enroll subjects.

What Happens in this study?

• Information will be collected from study participants’ medical records and by asking them questions during the time they are in the hospital.
• Participants will receive an infusion of the study drug or be treated as usual by their doctors. Assignment is determined by random chance, like the flip of a coin. Neither participants nor their doctors will know what assignment they receive.
• Some additional blood tests will be performed 3, 5, 28, and 90 days after enrollment.
• Participants may be asked for permission to collect additional blood for future studies to learn more about COVID-19.
• Participants will be contacted after they leave the hospital to see how they and doing and feeling.

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:

The study will evaluate the safety and efficacy of multiple investigational agents intended to enhance the host immune response to SARS-CoV-2 infection, or directly enhance viral control, in order to limit disease progression. Using a master protocol, successive trials within this protocol will be adaptive, randomized, and initially placebo-controlled. All participants will receive standard of care (SOC) treatment. If an investigational agent shows superiority over placebo + SOC as initially defined, SOC for future investigational treatment evaluations will be modified accordingly. The initial investigational agents will be neutralizing monoclonal antibodies.

Study Design:

Phase III multicenter, adaptive, randomized, blinded and placebo-controlled

Primary Objectives

Time from randomization to sustained recovery at day 90.

Secondary Objectives

• Organ dysfunction that may be associated with progression of COVID-19
• Extra-pulmonary manifestations of COVID-19

Study Size:

This study will enroll up to 1,000 people hospitalized due to COVID-19 infection.