As the global pandemic of COVID-19 evolves, the need to find safe and effective drugs for treatment is paramount. Currently, there is no vaccine and no licensed therapeutic agent to treat COVID-19.
TICO is an adaptive, international, randomised, blinded, placebo controlled platform trial to evaluate the safety and efficacy of different investigational agents (including neutralising monoclonal antibodies) intended to enhance the host immune response to SARS-CoV-2 infection, or directly enhance viral control in order to limit disease progression.
The trial is conducted by the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT). TICO uses a two-stage Phase 3 platform protocol design allowing multiple experimental therapeutics to be assessed against placebo during the course of the study. The first stage will enrol 300 participants to test safety and efficacy of the chosen experimental treatment. If an experimental treatment appears to be safe and effective, then it will progress to stage 2 to be studied in 1,000 participants. Eligible participants in both stages will have confirmed SARS-CoV-2 infection and their clinical outcome will be compared against placebo. Participants will be followed up for 90 days.
The TICO trial will determine if certain experimental treatments (including neutralising monoclonal antibodies) are effective in averting disease progression and mortality related to COVID-19. More specifically, it will evaluate respiratory and organ dysfunction associated with progression of COVID-19 disease.
This study will be important in establishing the therapeutic efficacy and safety of a range of potential treatments including neutralising monoclonal antibodies, which may lead to advancement in the control of the COVID-19 pandemic.
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health (NIH) ACTIV (The Accelerating COVID-19 Therapeutic Interventions and Vaccines)
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Copenhagen HIV Program (CHIP) – Copenhagen, Denmark
- Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL) – London, United Kingdom
- The Institute for Clinical Research at the Veterans Affairs Medical Center – Washington, D.C, USA.
- University of Minnesota – Clinical and Translational Science Institute – Minnesota, USA
- Cardiothoracic Surgical Trials Network USA (CTSN)
- Prevention and Early Treatment of Acute Lung Injury USA (PETAL)