mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms
Status:
Recruiting
Trial end date:
2022-06-15
Target enrollment:
Participant gender:
Summary
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential
treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune
system in the first 24 hours of infection, it ultimately produces a massive immune system
response in the subgroup of people who develop severe complications. Most tissue damage
following infection with COVID-19 appears to be due to a later, exaggerated, host immune
response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage.
Most people who develop these severe complications still have virus present in their
respiratory tract at the time-point when the disease starts to evolve. Immune modulation in
the presence of active infection has potential to cause more harm than benefit. Safety
considerations when studying immune modulation strategies are paramount. This study will
assess the efficacy of a novel immunomodulatory agent and a novel combination of approved
agents which may protect the patient against end-organ damage and modulate the pulmonary
vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel
combination of the approved agents dapagliflozin and ambrisentan against Standard of Care.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust