mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R)
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
TACTIC-R is a randomised, parallel arm, open-label platform trial for investigating potential
treatment 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 COVID19 appears to be due to a later, exaggerated, host immune
response. 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. Therefore, this
study proposes to assess the efficacy of immunomodulatory agents that target dysregulated
immune response that drive the severe lung, and other organ, damage. The medications
investigated for efficacy in this trial are Baricitinib and Ravulizumab.
Phase:
Phase 4
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust