Study Detail

DEFINE

Status: Suspended

Type: Interventional

Funder: not available

Sponsor: not available

CI: not available

IRAS-Number: 282934

CPMS-ID: 46450

Approval Date: 11 May 2020

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. Patients will be randomly given: - Nafamostat with standard hospital treatment - TD139 with standard hospital treatment / Standard hospital treatment. Both 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.

Description:

COVID-19 is a global health emergency with significant mortality and has the potential to devastate regions of the world with poor public health and underdeveloped critical care. The key clinical feature is rapid respiratory failure requiring mechanical ventilation (MV). There are no known treatments for COVID-19. The most vulnerable in society may not survive or be suitable for MV. The pandemic is overwhelming health systems across the globe and has the potential to devastate regions of the world with poor public health and underdeveloped critical care. The anticipated scale of the epidemic is such that hospitals, and particularly intensive care facilities, may be massively overstretched and overwhelmed. This study aims to support the re-purposing of promising pharmaceutical assets with prior use in humans through performing rapid experimental medicine feasibility studies in small groups of COVID-19 patients. The results of these studies will support further evaluation in existing national and international trial networks. The key interception is to prevent the lung damage in patients with COVID-19 that leads to respiratory failure. This programme will be comprised of small studies (detailed in the protocol appendices) and will focus on how effective the treatments are, as well as their impact on key inflammatory pathways in the body. This study will deliver an overarching and adaptive trial design/platform to provide urgent experimental medicine to support the further development / deployment of candidate therapies for COVID-19 patients.

Study URL:

https://www.ed.ac.uk/inflammation-research/clinical-trials/define-covid19

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