DEFINE [COVID-19] [UPH]
Research type
Research Study
Full title
Rapid Experimental Medicine for COVID-19
IRAS ID
282934
Contact name
Kevin Dhaliwal
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2020-002230-32
ISRCTN Number
ISRCTN14212905
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The purpose of this programme of trials is to evaluate the safety of treatments that are already used in patients for other diseases for use as treatments for patients with COVID-19. Safety will be assessed using blood tests, physical examination, blood pressure/heart rate/temperature and respiratory rate, daily electrocardiogram (ECG) to check how the heart is working, and adverse events. The results of these studies will support further national and international trials. The main aim is to prevent the lung damage in patients with COVID-19 that leads to respiratory failure. This programme will be comprised of small studies and will focus on how effective the treatments are, as well as their impact on inflammation in the body. The design of the trials will be changed as needed to support the further development of possible treatments for COVID-19 patients. \nPatients will be randomly given:\n•\tNafamostat with standard hospital treatment \n•\tTD139 with standard hospital treatment \n•\tStandard hospital treatment\nBoth Nafamostat and TD139 have been used in patients before and it is hoped they will reduce the effect of COVID-19. Nafamostat inhibits an enzyme in the body serine protease inhibitor and is routinely used to treat patients with a blood clotting disorder. It is given as a continuous infusion through a drip for 7 days. TD139 has been tested in healthy volunteers and patients with a type of lung disease that results in scarring of the lungs. It is given as an inhaler once or twice a day for 14 days. Information on the patient’s condition will be collected throughout the study.
REC name
Scotland A: Adults with Incapacity only
REC reference
20/SS/0066
Date of REC Opinion
23 Jun 2020
REC opinion
Further Information Favourable Opinion