TACTIC- E (COVID-19) [COVID-19] [UPH]
Research type
Research Study
Full title
mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Experimental drugs and mechanisms
IRAS ID
283769
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2020-002229-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
The COVID-19 pandemic is caused by a novel coronavirus (SARS-Cov-2). It is estimated that it will cause 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. \nTACTIC-E is a randomised, parallel arm, open-label, platform trial of potential disease modifying therapies in patients with late stage 1/stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical and radiological assessment. \nTACTIC-E is part of the TACTIC programme of research that will look at repurposing drugs and experimental drugs in the management of COVID-19 related complications. \nThe aim TACTIC-E trial is to determine if a novel immunomodulatory intervention reduces the composite progression of patients with COVID-19-related disease to organ failure or death.\nThe trial will have 2 treatment arms and a comparator arm using the following drugs: Dapagliflozin and Ambristentan (administered together) and EDP1815. The comparator is standard of care treatment. \n\n
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0169
Date of REC Opinion
9 Jun 2020
REC opinion
Further Information Favourable Opinion