TICO (Therapeutics for Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing 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.
The first wave of recruitment takes place in the USA, Spain, Denmark and Singapore with the first patient dosed on the 6th of August 2020 at Baylor, Scott and White Health in Dallas, USA. In the second wave of recruitment up to 400 sites will be registered worldwide and opened to recruitment following outbreaks of the pandemic around the world.
Estimated study period: Aug 2020 – July 2021.
Estimated enrolment: 10000 participants.
This treatment study 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) supported by the NIH’s National Heart, Lung and Blood Institute through the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) program and the US Department of Veterans Affairs (VA).
For more information about the study, please contact email@example.com
This study has received funding from the National Institutes of Health (NIH).