Multiarm Therapeutic study in pre-ICU patients admitted with COVID-19 - Repurposed Drugs
Funder: Ely Lilly and Company; Alexion Pharmaceuticals
Sponsor: Cambridge University Hospitals NHS Foundation Trust
CI: Dr Frances Hall & Prof David Jayne
Approval Date: 11 May 2020
Several medicines for patients with autoimmune disease (where your immune system mistakenly attacks your body) can be used to prevent overactivation of the immune response (the body's defence against foreign invaders) in severe COVID-related disease. This study (TACTIC-R) plans to treat patients at an early stage in the disease where the patient is experiencing early infection and starting to show mild lung complications. The purpose is to prevent organ damage and reduce the need to transfer to the Intensive Care Unit and the need for artificial ventilation. Patients will receive one of 3 treatments: baricitinib for 14 days plus normal hospital treatment; ravulizumab single dose plus normal hospital treatment; normal hospital treatment alone. Patients will be followed up after 28 days and 3 months and will undergo blood testing as part of the routine care. The aim of this trial is to identify drugs that can reduce the number of COVID-19 patients that need to be admitted to the Intensive Care Unit.
The COVID-19 pandemic is caused by a novel coronavirus (SARS-Cov-2). It is causing a significant number of deaths in the UK alone due to the complications that can arise in older patients and those with other comorbidities. While there are no current vaccines, prophylactic or therapeutic agents of proven efficacy, several medications licensed for patients with autoimmune disease can be used to prevent overactivation of the immune response in severe COVID-related disease. TACTIC is recruiting patients at an early stage in the disease course, aiming for a time point where the patient is experiencing infective symptoms and starting to show pulmonary complications. The purpose is to prevent organ damage and reduce the need to transfer to ICU and ventilation. The trial has 2 treatment arms and a comparator arm using the following drugs: Baricitinib and Ravulizumab. TACTIC trial aims to currently randomise COVID-19 positive patients into 3 arms, 2 active and 1 comparator. Arm 1 and 2 consists of baricitinib and ravulizumab respectively. Arm 3 consists of standard of care alone. Subjects are treated with their assigned regime during 14 days. Depending on the drug regimen they are assigned to, patients will either have 14-day dosing (baricitinib) or a single dose (ravulizumab). After the treatment phase, patients will have a 28 days and 3 month follow up. Patients will undergo blood testing as part of the routine care, and data relevant for the study will be taken from medical records whenever possible. Arms may be added or stopped depending on data and a recommendation from the independent data monitoring committee. The aim of this trial is to reduce the number of COVID-19 patients that will be admitted to ICU. Candidates: Ravulizumab, Baricitinib
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