Cambridge University Hospitals group is launching a fast-turnaround experimental drug trial to treat Covid-19.
Two new treatments which tackle aspects of the coronavirus infection are to be tested in the 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.
The trial 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 drugs to be used in the trial is called EDP1815. The other arm of the trial will involve using two drugs in combination: Dapagliflozin and Ambrisentan.
What is EDP1815, and what does it do?
EDP1815 is a new but unlicensed drug that is manufactured by Evelo. Itworks 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.
More on Dapagliflozin and Ambrisentan
This area of the trial is supported by Astrazeneca. The two drugs, Dapagliflozin and Ambrisentan, are currently 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.
Addenbrooke's is one of the hospitals involved in the trials. 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 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.
“Covid-19 is a complex disease that affects people in different ways across the world, and we are going to need a range of treatments in our armoury to be able to beat it. Each drug may bring a small but incremental benefit to patients, therefore it is likely that testing and progressing combinations of drugs which have a sound scientific and clinical outcome is likely to have a larger impact than conducting single arm trials in large numbers of people before effects are seen."
With cases of Covid-19 in the UK falling, investigators of TACTIC-E plan to extend the study to countries where the disease is now very common, so that any early indicators can be spotted, and benefits to patients realised as soon as possible.
“TACTIC-E will test the effectiveness of a number of new drugs in patients admitted to hospital, but with a strong focus on identifying novel and clinically useful drugs early on as well as collecting high quality data that can be used by our partner pharmaceutical companies to seek the necessary approvals for widespread international use.”
Coronavirus: Everything you need to know