Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients. BMC Infectious Diseases
Kusejko et al. developed and implemented a trial platform (COVERALL) within the frameworks of the Swiss HIV Cohort Study (SHCS) and the Swiss Transplant Cohort Study (STCS). The platform leverages the well-established data infrastructure of the two cohorts and allows to enroll their participants into randomized trials in a very efficient way with minimal administrative burden.
A trial data collection tool developed with REDCap was connected to the cohort databases, and pre-existing baseline information was then used for automatic patient selection based on user-provided eligibility criteria. Cohort participants were flagged within the cohort data entry tool as potentially eligible for the trial, with trial inclusion of the patient being possible with one click. After inclusion, baseline data from the cohorts were automatically used for the stratified randomization algorithm.
The implementation of the trial platform started in August 2020, and was used to compare the efficacy of the two mRNA vaccines against SARS-CoV-2 (Comirnaty and Spikevax) in individuals with HIV or solid organ transplants. Final ethics approval of the trial protocol was obtained on 15th April 2021, and the first patient was randomized on 19th April. Within four days, 40 individuals were recruited, and the full study population of 380 patients was recruited within 22 days.
Implementing randomized trials within cohorts has many advantages, which include rapid identification of individuals, collection of longitudinal data, which can complement trial analyses, and a low rate of loss to follow-up as individuals remain within the cohort. The COVERALL trial platform allowed the study team to identify and enroll cohort participants into the trial within a matter of weeks and therefore proved to be a highly valuable tool for future trials in the SHCS as well as the STCS.