Two new treatments which tackle Covid-19 are to be tested in an innovative trial which will respond quickly to results from small numbers of patients.
The newly launched trial, known as TACTIC-E (the “E” stands for “experimental”), has been designed to test drugs that have been specifically developed to treat Covid-19 as well as investigating whether combinations of drugs that are already in use can be effective.
It will determine whether the major organ complications in severe Covid-19 can be reduced (or prevented) by targeting previously unexplored pathways – via the gut to reduce the inflammatory response, and via the inner lining of blood vessels to help increase the amount of oxygen available in the lungs.
One of the new but unlicensed drugs to be trialled is EDP1815, manufactured by Evelo. It works on the gut microbiome (the communities of healthy bacteria that live in the digestive tract), but is not absorbed into the body. The microbiome links up with the rest of the inflammatory system in the body and using a drug which works solely in the gut may have advantages above and beyond any other drug since it has fewer side effects.
The other trial arm is supported by Astrazeneca and aims to use two drugs used in combination: dapagliflozin and ambrisentan. They are licensed in the UK for use in diabetes and pulmonary arterial hypertension respectively. Doctors believe that by using them together, it could help combat the heart and lung problems often seen in patients with serious Covid-19.
Patients with Covid-19 who are admitted to Addenbrooke’s Hospital will be screened to see if either of the drug regimens would be suitable for them compared to standard of care. If so, they will be invited to take part in the trial. As always, only patients who give their consent will be admitted to the trial.
The trial is led by the Cambridge University Hospitals NHS Trust and is supported by the NIHR Cambridge Biomedical Research Centre. Funding and drug supply for the trial has been provided by Astrazeneca and Evelo Biosciences.