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
