TACTIC-E

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Multi-Arm Therapeutic Study in Pre-ICU Patients Admitted with COVID-19

– Experimental Drugs

The TACTIC-E clinical trial is testing whether novel therapeutic agents or novel combinations of approved agents can prevent the development of severe symptoms in patients hospitalised with confirmed COVID-19. By targeting the exaggerated host response mechanisms driving the severe lung and other organ damage seen in coronavirus infection, this approach is a way of finding out whether these novel approaches are effective in treating the disease.

The treatments currently being tested in TACTIC-E are:

EDP1815 – to modulate abnormal immune and inflammatory response to acute viral infection
Ambrisentan in combination with Dapagliflozin – to treat respiratory, cardiovascular and renal complications from COVID-19

The platform design used by TACTIC-E provides flexibility to swap out and add in alternative treatments based on emerging data as the trial progresses.

Welcome to the patients area for the TACTIC-E trial. This trial is recruiting people who have been hospitalised with confirmed COVID-19 disease. The purpose of this trial is to prevent organ damage and reduce the need to transfer patients to ICU and ventilation.

The following information will provide answers to questions you might have about this trial:

Patient Information Sheet and Informed Consent Form (Short Version)

Patient Information Sheet and Informed Consent Form (Full Version)

What is the purpose of the trial?

COVID-19 was declared a pandemic on 11^th March 2020 by the World Health Organisation (WHO). It is a disease affecting the lungs, and is caused by a new coronavirus known as SARS-CoV2. Most people with the virus have mild symptoms. However, some people, for example older adults and those with underlying health conditions including heart disease and diabetes, may develop more severe symptoms, leading to hospitalisation, increased support for breathing (e.g. use of a ventilator in an intensive care unit) or even death. There are currently no vaccines against the virus, or proven treatments to treat it.

Some of the severe symptoms of the virus are thought to be a result of an overactive immune response, leading to organ damage in the body. The purpose of this trial is to determine the best way to treat patients with COVID-19 infection by comparing different treatments which act on the immune system, with the aim of reducing severe symptoms and therefore the number of Intensive Care Unit (ICU) admissions in hospital.

What are the drugs being tested?

The treatments are:

EDP 1815 is a microbe found in human intestines which is thought to have a calming effect on an overactive immune system
Ambrisentan and Dapagliflozin are two different drugs, each taken as a single capsule once daily. Ambrisentan is a licensed drug which targets the walls of blood vessels in the lungs and blunts inflammatory activity in the lungs. It is commonly used to treat a condition known as pulmonary arterial hypertension. Dapagliflozin is a licensed drug which helps the kidneys excrete glucose and it is commonly used in type 2 diabetes mellitus.

All trial participants will receive standard of care. Both types of trial treatments are being compared to being on standard care only. Some patients will be randomised to standard care arm only (which may include standard antivirals), that is without any new drug.

TACTIC-E will use a platform design. A "platform trial" is a clinical trial with a master protocol, which allows for multiple treatments to enter or exit the trial over the course of the study. This means that the trial team can, with interim analyses, stop recruiting to treatment groups (arms) early where a clear early decision can be made. It also allows for the addition of further arms and treatments. If the treatment you have been assigned to is stopped, you will immediately stop treatment.

Who is being invited to take part?

Patients may be invited to participate in this trial if they are or are suspected to be COVID-19 positive, are considered to be at higher risk of developing serious symptoms, and where it is believed Ambrisentan and Dapagliflozin or EDP1815 may be suitable treatments.

We plan to include up to 469 patients (in each arm) with COVID-19 disease from a number of hospitals across the UK.

Do I have to take part?

No, participating in this trial is completely voluntary. If you do decide to participate you will be asked to sign an Informed Consent Form, however you are still free to change your mind and leave the trial at any time without giving a reason. If you choose not to participate or to leave the trial, your future medical treatment will not be affected in any way.

Welcome to the staff area for the TACTIC-E trial. Adult COVID-19 patients may be invited to take part in this trial if they meet criteria for having a high likelihood of benefit from immunomodulation. A risk count has been developed to assist with the identification of patients admitted with a clinical/laboratory diagnosis of COVID19 who are at increased risk of developing severe COVID19-related disease. A video with further information about the scoring system for patient selection is available in the Training area.

Eligible patients will be randomised using a central web-based randomisation service to one of three arms initially: EDP1815, Ambrisentan with Dapagliflozin or usual standard of care.

Protocol and Poster

Trial Protocol

Trial Poster

Patient Information Sheet and Informed Consent Form

Patient Information Sheet and Informed Consent Form (Short Version)

Patient Information Sheet and Informed Consent Form (Full Version)

Additional Patient Facing Documents