A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with Acute Respiratory Distress Syndrome Associated with COVID-19 (INSIGHT 015)
 

This treatment study is a collaboration of INSIGHT and three other research networks: Cardiothoracic Surgical Trials Network (CTSN), Prevention and Early Treatment of Acute Lung Injury (PETAL) and the US Department of Veterans Affairs (VA). Several hundred clinical sites from the various networks will participate in the study.

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.

For more details about the study, please go to ClinicalTrials.gov.