mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms

  • STATUS
    Recruiting
  • participants needed
    1407
  • sponsor
    Cambridge University Hospitals NHS Foundation Trust
Updated on 6 July 2022
covid-19
SARS

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.

Description

TACTIC-E will assess the efficacy of the novel immunomodulatory agent EDP1815 and a combination of the approved cardiovascular drugs dapagliflozin and ambrisentan as potential treatments for COVID-19 disease against Standard of Care alone. These agents target the dysregulated immune response that drive the severe lung, and other organ, damage frequently seen during COVID-19 infection, with an aim to promote a positive vascular response to reduce end-organ damage.

Treatment with EDP1815 will be for up to 7 days, with the option of extension to 14 days at the discretion of the PI or their delegate, if the patient is felt to be clinically responding to treatment, is tolerating treatment, and is judged to be likely to benefit from a longer treatment course. Treatment with combination dapagliflozin and ambrisentan will be for up to 14 days. Patients will be randomised in a 1:1:1 ratio across treatments.

TACTIC-E will use a platform design with interim analysis to make efficient decisions about efficacy and futility (e.g. lack of efficacy and risk of harm) of the trial treatments. This enables the trial to stop recruiting to arms early where a clear efficacy decision can be made. It also allows for the addition of further arms.

Details
Condition *COVID-19, Covid-19
Treatment Standard of Care, Dapagliflozin, Ambrisentan, EDP1815
Clinical Study IdentifierNCT04393246
SponsorCambridge University Hospitals NHS Foundation Trust
Last Modified on6 July 2022

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