A Study for Efficacy and Safety of MRx4DP0004 to Treat COVID-19 [COVID-19]
Research type
Research Study
Full title
A pilot, multiple dose study to evaluate the efficacy and safety of MRx-4DP0004 in hospitalised patients with symptoms of COVID-19 (SARS-CoV-2 infection)
IRAS ID
282817
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
4D Pharma plc
Eudract number
2020-001597-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
This study will be performed in hospitalised adult male and female patients who have symptoms which indicate COVID-19 (or coronavirus disease 2019) - the disease caused by infection with the SARS-CoV-2 virus which affects the lungs and airways. As COVID-19 is a new disease there are currently no medicines licensed specifically to treat or prevent it. The study is sponsored by 4D pharma plc in Leeds, UK.\nThe drug being investigated is called MRx-4DP0004. MRx-4DP0004 is a live biotherapeutic product (LBP) containing the bacteria Bifidobacterium breve (B. breve). B. breve has been freeze-dried and put into a capsule so that it can be taken by mouth and swallowed. Each capsule contains around ten thousand million (10,000,000,000) dried B. breve bacteria. B. breve is found naturally in the gastrointestinal tract (gut) in humans and is used in probiotics (such as yoghurt drinks). MRx-4DP0004 has been given to people with asthma taking part in another research study previously. In severe cases of COVID-19, patients have been shown to have higher levels of cells involved in inflammation. MRx-4DP0004 has been shown to have anti-inflammatory effects in animals. \nThe purpose of this study is to find out if taking MRx-4DP0004 is safe and if it is better at stopping COVID-19 from becoming severe than standard of care alone. In this study participants will receive either MRx-4DP0004 or a placebo (dummy pill) in a 2:1 ratio, 2 capsules twice a day for up to 14 days, in addition to standard of care. As they will also be treated with the standard of care, even if they are taking a placebo, they will never be without appropriate treatment. In addition to the 14 day treatment period there will be a follow-up period of up to 28 days. Around 90 adult male and female hospitalized patients will be enrolled.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0161
Date of REC Opinion
29 May 2020
REC opinion
Further Information Favourable Opinion