INSIGHT photo 0 INSIGHT photo 1 INSIGHT photo 2 INSIGHT photo 3

COVID-19 Studies

In December 2019, the Wuhan Municipal Health Committee in Wuhan, China, identified an outbreak of viral pneumonia cases of unknown cause. Coronavirus RNA was quickly detected in some of the affected patients. This novel coronavirus has since been designated SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. This disease quickly spread to locations outside of China and the incidence grew exponentially. On January 30, 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a global health emergency and, on March 12, 2020, WHO declared the outbreak a pandemic.

The Divisions of Microbiology and Infectious Diseases (DIMID) and the Clinical Research (DCR) at NIAID, NIH requested support for development and implementation of COVID-19 research needed to understand the natural history of the disease, identify risk factors for disease progression, and determine the safety and efficacy of novel therapeutics. In response, INSIGHT has assisted with, or initiated, multiple COVID-19 studies.


A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19 (INSIGHT 014)

This treatment study is a collaboration of INSIGHT and four other research networks: Cardiothoracic Surgical Trials Network (CTSN), Prevention and Early Treatment of Acute Lung Injury (PETAL), the US Department of Veterans Affairs (VA) and the Division of Clinical Research. INSIGHT was selected by the ACTIV mAb Master Protocol Steering Committee, Foundation for the National Institutes of Health, as the lead network for the trial. Several hundred clinical sites from the various networks will participate in the study.

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.

Protocol synopsis

Listing of sites

INSIGHT TICO ClinicalTrials.gov identifier: NCT04501978

INSIGHT TICO EudraCT number: 2020-003278-37

INSIGHT Footer
Email Webmaster with questions or suggestions.