A Pilot, Safety, Efficacy and Feasibility Double-Blind Randomised Controlled Trial of Scp776 for Neuroprotection in Comatose Adults Resuscitated After Out-of-Hospital Cardiac Arrest

INTERVENTION: Eligible patient s will be enrolled as soon as possible after admission to hospital and within 240 minutes of return of spontaneous circulation. A registered nurse or medical doctor delegated by the site principal investigator will administer to two intravenous doses of scp776 100 mg while the participant is admitted to hospital. The first dose of scp776 must be administered within 1 hour of randomisation. The second dose of study drug should be administered at approximately the same time the following day (24 h plus or minus 30 minutes from first dose). A review of medical records will confirm the date and time of study drug administration. CONDITION: Cardiac Arrest; ; Cardiac Arrest Cardiovascular ‐ Other cardiovascular diseases PRIMARY OUTCOME: Volume of brain injury between the scp776 group and the placebo group as calculated by automated assessment of brain magnetic resonance imaging.[As calculated by automated assessment of brain magnetic resonance imaging scan data. Brain magnetic resonance imaging is to be performed between 72 – 96 hours following randomisation and data extracted from the patients electronic medical record.] SECONDARY OUTCOME: Adverse event[Review of clinician‐reported adverse drug events that include episodes of low blood sugar levels of less than 3.3 mmol per litre, tachycardia (defined in our study as a heart rate that exceeds 100 beats/min and requires medical intervention) and bleeding that occurs during the 24 hours after study drug administration. As recorded in the participant electronic medical record occurring in the first seven days from randomisation.] Degree of functional outcome, defined as a score of 4 to 6 using the 6‐point modified Rankin scale ; [modified Rankin scale to assess the degree of functional disability in patients after cardiac arrest. Noting, that the modified Rankin scale has a range of 0 [no symptoms] to ; score of 0 [no symptoms] to 6 [death], with lower scores indicating poorer functional outcome. Assessed at 30‐days and si Xmonths after randomisation.] Degree of neurological outcome, defined as a score of 5 or greater using the 8‐point Glasgow Outcome Scale Extended method [Glasgow Outcome Scale Extended, to assess the degree of neurological disability in patients after cardiac arrest. Noting, the Glasgow Outcome Scale–Extended has a range of 1 [death] to 8 [upper good recovery] , with higher scores indicating better neurologic outcome. As assessed at si Xmonths after randomisation] Health‐related quality of life[EuroQol‐5D‐5L questionnaire As assessed at si Xmonths after randomisation] Serial serum neurofilament light chain concentrations between the scp776 group and the placebo group.[Laboratory analysis Serum blood samples to be obtained at baseline, 24 hours, 48 hours and 72 hours in patients admitted to hospital.] Study drug administration[Medical record audit of study drug administration in participant's electronic medical record As recorded in the participant electronic medical record occurring in the first 48 hours of the participant's admission to hospital.] INCLUSION CRITERIA: Adult age equal to or greater than 18 years of age Out‐of‐hospital cardiac arrest of a presumed cardiac or unknown cause Sustained return of spontaneous circulation defined as 20 minutes with signs of circulation without the need for chest compressions. Unconscious defined as a FOUR‐score motor response of less than 4 which is not able to obey verbal commands after sustained return of spontaneous circulation Eligible for intensive care without restrictions or limitations Within 240 minutes of return of spontaneous circulation