Presymptom Health’s PRECISION trial began recruiting patients on 5 May 2021. The trial, which is led by Dr Paul Schmidt of Queen Alexandra Hospital, Portsmouth, also includes researchers and clinicians from Guy’s & St Thomas’, The Rotherham Foundation Trust, and North Tees & Hartlepool Trust. Additional sites may also soon be included.
As shown below, the trial aims to recruit a total of up to 600 patients by Q3 2022 across the four participating sites. Up to a third of patients will have confirmed COVID disease.
PRECISION is a multi-centre observational cohort study consecutively recruiting patients to two cohorts, COVID-19+ ALTRIs and COVID-19- ALTRIs (Acute Lower Respiratory Tract Infections). Patients provide informed consent to participate in the study. Daily blood sample collection will be conducted for 4 days, starting at admission. Anonymized patient demographic data, all clinical measures and outcome data generated during routine clinical care will be retrospectively collected. Outcomes will be censored to seven days. Clinical adjudicators will review each case to determine if the Sepsis-3 criteria for acute organ dysfunction had occurred and the likely cause. Interim data analysis will be performed after the recruitment of 150 patients (end-Q1, 2022) to improve point estimates of outcomes in order to adjust the required numbers of patients in each cohort.
PRECISION is designed to determine the accuracy of Presymptom Health’s gene host response biomarker signatures to predict organ dysfunction/failure in all ALTRI patients, including both COVID-19+ve patients and COVID-19-ve patients. The study is powered to assess endpoints of clinical deterioration and sepsis. Outcome measures being tracked include intensive care, coronary care, respiratory high care admission, organ support (Organ support (inotropes, ventilation support, renal) and end of life care decisions. Acute organ dysfunction will be identified according to conventional criteria, namely an increase in the Sequential Organ Failure Assessment score (SOFA score) of 2 or more from baseline at the time of recruitment to the study.
It is anticipated that the PRECISION trial will read out in late Q3, 2022.
The PRECISION trial has been reviewed by the Research Ethics Council and the Health Research Authority (REC number: 21/SC/0048).