Evidence map›Paper›PMID 35902817›Full record

ArticleBMC infectious diseases2022

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

Katharina Kusejko, Frédérique Chammartin, Daniel Smith, Marc Odermatt, Julian Schuhmacher, Michael Koller, Huldrych F Günthard, Matthias Briel, Heiner C Bucher, Benjamin Speich and 2 more

Registry-linked trialAbstract read
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In one paragraph

Article in BMC infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04805125 (Randomised Controlled Trials to Assess Approved SARS-CoV-2 Vaccines in Immunocompromised Patients), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04805125 phase3completednot on this map

Randomised Controlled Trials to Assess Approved SARS-CoV-2 Vaccines in Immunocompromised Patients: A Master Protocol for the Set-up of a Swiss Cohorts Based Trial Platform

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2021 to 2023Enrolled610ConditionsImmunocompromised PatientsArmsModerna COVID-19 Vaccine, mRNA-1273 (100 μg), Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Katharina KusejkoInstitute of Medical Virology, University of Zurich, Zurich, Switzerland. katharina.kusejko@usz.ch.
Frédérique ChammartinBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Daniel SmithInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Marc OdermattInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Julian SchuhmacherInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Michael KollerBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Huldrych F GünthardInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Matthias BrielBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Heiner C BucherBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Benjamin SpeichBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Swiss HIV Cohort Study
Swiss Transplant Cohort Study

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 31CA30_196245Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 33CS30_177499/201369Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 33CS30_177522/201385
6 · The paper itself

Abstract

backgroundThe 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.

methodsWe 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.

resultsUsing 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.

conclusionTaking 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.

Indexed as

COVID-19COVID-19 VaccinesCohort StudiesHumansImmunocompromised HostSARS-CoV-2Treatment OutcomeCOVID-19 VaccinesHIVImmunocompromisedREDCapSARS-CoV-2Transplant patientsTrial platform

Identifiers

PMID35902817
PMCPMC9330973

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.