TICO/ACTIV-3/INSIGHT-014
Does giving patients hospitalised with COVID-19 a synthetically made antibody that blocks the virus make them get better more quickly?
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19
What is this study about?
TICO is an international master protocol which evaluated the safety and effectiveness of multiple new investigational agents, including neutralising antibodies that worked by blocking SARS-CoV-2, the virus that causes COVID-19.
This master protocol was adaptive – which means it was flexible. Participants were randomised to receive the new investigational agent(s) in addition to the current standard-of-care which included the antiviral drug, remdesivir. TICO globally enrolled over 2750 adults hospitalised with COVID-19. Any investigational agent(s) which was shown to be effective, will become the new ‘standard-of-care’ treatment, with far-reaching global benefits.
Publications:
- A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19
- Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial
- Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19
- Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
- Responses to a neutralizing monoclonal antibody for hospitalized patients with COVID-19 according to baseline antibody and antigen levels: A randomized controlled trial
Contact details
Who is funding the study?
National Institute of Allergy and Infectious Diseases, National Institutes of Health (USA)
When is it taking place?
Trial completed global closure on 11th July 2023. The trial enrolled participants from July 2020 – December 2021 with 18 months follow-up.
Where is it taking place?
France, Greece, Italy, Ireland, Switzerland, Uganda, UK and a number of other EU countries, USA, Central and South America, and SE Asia
Who is included?
Patients ≥18 years old admitted to hospital and diagnosed with SARS-CoV-2 infection