PROTECT
Research type
Research Study
Full title
A PROspective, single centre, randomized, controlled phase II clinical Trial investigating the EfficaCy and safety of the P2X7 antagonist JNJ-54175446 in patients with severe Traumatic brain injury
IRAS ID
1005144
Contact name
Antonio Belli
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2021-005565-41
Research summary
Due to traumatic brain injury (TBI), a severe immune reaction can occur in which the body releases too many chemicals that cause inflammation called cytokines into the blood too quickly. Cytokines play an important role in normal immune responses, but having a large amount of them released in the body all at once can be harmful. It is important for the immune system to reduce this cytokine release and help the body recover from injury and fight infections. JNJ-54175446 has been shown to control/reduce this cytokine levels within the body. Patients who consent to take part in the trial will be allocated a place in the trial (randomly assigned by chance by a computer) and will receive either JNJ-54175446 and routine care OR routine care only.
The aim of this trial is to determine if JNJ-54175446 can reduce the cytokine levels within the brain and aid recovery from injury. We will measure the cytokine levels and JNJ-54175446 levels in your blood and monitor the response to the treatment
We will invite 50 patients to take part from a single centre in the UK.
Patients will be closely monitored for any side-effects; for changes in TBI symptoms. At the end of the study, we will hopefully know if JNJ-54175446 is safe and if it is acceptable to TBI patients.
The trial period for patient participation is 28 days. We hope to recruit all 50 patients over a 21 month period (1 year and 9 months). We plan to recruit the first patient in May/June 2022.
Once the last patient has completed the last visit, the data collection will be closed and data analysed. We anticipate a trial report within 12 months of the last patient completing the study. This will be end of quarter one 2025.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0085
Date of REC Opinion
1 Jun 2022
REC opinion
Further Information Unfavourable Opinion