Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients.
Details
Serval ID
serval:BIB_66CD4B7631A4
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients.
Journal
BMC infectious diseases
Working group(s)
Swiss HIV Cohort Study, Swiss Transplant Cohort Study
Contributor(s)
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., Amico P., Aubert J.D., Banz V., Beckmann S., Beldi G., Berger C., Berishvili E., Berzigotti A., Binet I., Bochud P.Y., Branca S., Bucher H., Catana E., Cairoli A., Chalandon Y., De Geest S., De Rougemont O., De Seigneux S., Dickenmann M., Dreifuss J.L., Duchosal M., Fehr T., Ferrari-Lacraz S., Garzoni C., Golshayan D., Goossens N., Halter FHJ, Heim D., Hess C., Hillinger S., Hirsch H.H., Hirt P., Hofbauer G., Huynh-Do U., Immer F., Koller M., Laager M., Laesser B., Lamoth F., Lehmann R., Leichtle A., Manuel O., Marti H.P., Martinelli M., McLin V., Mellac K., Merçay A., Mettler K., Müller A., Mueller N.J., Müller-Arndt U., Müllhaupt B., Nägeli M., Oldani G., Pascual M., Passweg J., Pazeller R., Posfay-Barbe K., Rick J., Rosselet A., Rossi S., Rothlin S., Ruschitzka F., Schachtner T., Schanz U., Schaub S., Scherrer A., Schnyder A., Schuurmans M., Schwab S., Sengstag T., Simonetta F., Stampf S., Steiger J., Stirnimann G., Stürzinger U., Van Delden C., Venetz J.P., Villard J., Vionnet J., Wick M., Wilhelm M., Yerly P.
ISSN
1471-2334 (Electronic)
ISSN-L
1471-2334
Publication state
Published
Issued date
28/07/2022
Peer-reviewed
Oui
Volume
22
Number
1
Pages
654
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Publication Status: epublish
Abstract
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.
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.
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.
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.
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.
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.
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.
Keywords
COVID-19/prevention & control, COVID-19 Vaccines, Cohort Studies, Humans, Immunocompromised Host, SARS-CoV-2, Treatment Outcome, HIV, Immunocompromised, REDCap, Transplant patients, Trial platform
Pubmed
Web of science
Open Access
Yes
Create date
25/08/2022 7:25
Last modification date
26/03/2024 7:10
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