Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients
Authors: Kusejko Katharina , Chammartin Frédérique , Smith Daniel , Odermatt Marc , Schuhmacher Julian , Koller Michael , Günthard Huldrych F. , Briel Matthias , Bucher Heiner C. , Speich Benjamin ,   the Swiss HIV Cohort Study, Abela I. , Aebi-Popp K. , Anagnostopoulos A. , Battegay M. , Bernasconi E. , Braun D. L. , Bucher H. C. , Calmy A. , Cavassini M. , Ciuffi A. , Dollenmaier G. , Egger M. , Elzi L. , Fehr J. , Fellay J. , Furrer H. , Fux C. A. , Günthard H. F. , Hachfeld A. , Haerry D. , Hasse B. , Hirsch H. H. , Hoffmann M. , Hösli I. , Huber M. , Kahlert C. R. , Kaiser L. , Keiser O. , Klimkait T. , Kouyos R. D. , Kovari H. , Kusejko K. , Martinetti G. , Martinez de Tejada B , Marzolini C. , Metzner K. J. , Müller N. , Nemeth J. , Nicca D. , Paioni P. , Pantaleo G. , Perreau M. , Rauch A. , Schmid P. , Speck R. , Stöckle M. , Tarr P. , Trkola A. , Wandeler G. , Yerly S. ,   Swiss Transplant Cohort Study, Amico Patrizia , Aubert John-David , Banz Vanessa , Beckmann Sonja , Beldi Guido , Berger Christoph , Berishvili Ekaterine , Berzigotti Annalisa , Binet Isabelle , Bochud Pierre-Yves , Branca Sanda , Bucher Heiner , Catana Emmanuelle , Cairoli Anne , Chalandon Yves , De Geest Sabina , De Rougemont Olivier , De Seigneux Sophie , Dickenmann Michael , Dreifuss Joëlle Lynn , Duchosal Michel , Fehr Thomas , Ferrari-Lacraz Sylvie , Garzoni Christian , Golshayan Déla , Goossens Nicolas , Halter Fadi Haidar Jörg , Heim Dominik , Hess Christoph , Hillinger Sven , Hirsch Hans H. , Hirt Patricia , Hofbauer Günther , Huynh-Do Uyen , Immer Franz , Koller Michael , Laager Mirjam , Laesser Bettina , Lamoth Frédéric , Lehmann Roger , Leichtle Alexander , Manuel Oriol , Marti Hans-Peter , Martinelli Michele , McLin Valérie , Mellac Katell , Merçay Aurélia , Mettler Karin , Müller Antonia , Mueller Nicolas J. , Müller-Arndt Ulrike , Müllhaupt Beat , Nägeli Mirjam , Oldani Graziano , Pascual Manuel , Passweg Jakob , Pazeller Rosemarie , Posfay-Barbe Klara , Rick Juliane , Rosselet Anne , Rossi Simona , Rothlin Silvia , Ruschitzka Frank , Schachtner Thomas , Schanz Urs , Schaub Stefan , Scherrer Alexandra , Schnyder Aurelia , Schuurmans Macé , Schwab Simon , Sengstag Thierry , Simonetta Federico , Stampf Susanne , Steiger Jürg , Stirnimann Guido , Stürzinger Ueli , Van Delden Christian , Venetz Jean-Pierre , Villard Jean , Vionnet Julien , Wick Madeleine , Wilhelm Markus , Yerly Patrick 
Published: July 2022

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.