General public

What is ACTIV-3b/TESICO?

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-3b/TESICO 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-3b/TESICO is designed to evaluate the safety and effectiveness of different drugs in treating acute respiratory failure related to COVID-19. The focus of this trial is on patients with critical respiratory failure and recruits many of its patients in ICU settings.

Who can be in this study?

Adults admitted to the hospital with a positive COVID-19 test in the prior 14 days and current respiratory failure due to COVID-19 may be eligible for this study. Only hospitals that are part of the INSIGHT Network 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(s) or be treated as usual by 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 on enrollment and at days 3 & 5 if participants are still in the hospital
• 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 investigational agents aimed at improving outcomes of patients with acute respiratory failure related to COVID-19. 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 first investigational agents studied will be aviptadil (generic name for the synthetic version of Vasoactive Intestinal Peptide [VIP]) and remdesivir in a 2x2 factorial design.

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 approximately 640 people for each investigational agent/placebo.