Journal Article

Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients

Koller, Michael, Kusejko, Katharina, Günthard, Huldrych F., Bucher, Heiner C., Schuhmacher, Julian, Briel, Matthias, Speich, Benjamin, Odermatt, Marc, Chammartin, Frédérique, Smith, Daniel

2022

Overview

Background The rapid course of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic calls for fast implementation of clinical trials to assess the effects of new treatment and prophylactic interventions. Building trial platforms embedded in existing data infrastructures is an ideal way to address such questions within well-defined subpopulations. Methods We developed a trial platform building on the infrastructure of two established national cohort studies: the Swiss human immunodeficiency virus (HIV) Cohort Study (SHCS) and Swiss Transplant Cohort Study (STCS). In a pilot trial, termed Corona VaccinE tRiAL pLatform (COVERALL), we assessed the vaccine efficacy of the first two licensed SARS-CoV-2 vaccines in Switzerland and the functionality of the trial platform. Results Using Research Electronic Data Capture (REDCap), we developed a trial platform integrating the infrastructure of the SHCS and STCS. An algorithm identifying eligible patients, as well as baseline data transfer ensured a fast inclusion procedure for eligible patients. We implemented convenient re-directions between the different data entry systems to ensure intuitive data entry for the participating study personnel. The trial platform, including a randomization algorithm ensuring balance among different subgroups, was continuously adapted to changing guidelines concerning vaccination policies. We were able to randomize and vaccinate the first trial participant the same day we received ethics approval. Time to enroll and randomize our target sample size of 380 patients was 22 days. Conclusion Taking the best of each system, we were able to flag eligible patients, transfer patient information automatically, randomize and enroll the patients in an easy workflow, decreasing the administrative burden usually associated with a trial of this size.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Algorithms / Antibodies / Cardiovascular disease / Clinical trials / Cohort analysis / Coronaviruses / COVID-19 / COVID-19 vaccines / Data capture / Data collection / Data transfer (computers) / HIV / Human immunodeficiency virus / Immunocompromised / Immunocompromised host / Immunocompromised hosts / Infectious Diseases / Informed consent / Infrastructure / Internal Medicine / Laboratories / Medical Microbiology / Medical research / Medicine / Medicine & Public Health / Methods / Nurses / Pandemics / Parasitology / Patients / Public health / REDCap / SARS-CoV-2 / Severe acute respiratory syndrome coronavirus 2 / Subgroups / Subpopulations / Testing / Transplant patients / Transplants & implants / Trial platform / Tropical Medicine / Vaccine efficacy / Vaccines / Viral diseases / Workflow