Cohort Profile: Post-hospitalisation COVID-19 study (PHOSP-COVID)

Abstract

PHOSP-COVID is a national UK multi-centre cohort study of patients who were hospitalised for COVID-19 and subsequently discharged.

PHOSP-COVID was established to investigate the medium- and long-term sequelae of severe COVID-19 requiring hospitalisation, understand the underlying mechanisms of these sequelae, evaluate the medium- and long-term effects of COVID-19 treatments, and to serve as a platform to enable future studies, including clinical trials.

Data collected covered a wide range of physical measures, biological samples, and Patient Reported Outcome Measures (PROMs).

Participants could join the cohort either in Tier 1 only with remote data collection using hospital records, a PROMs app and postal saliva sample for DNA, or in Tier 2 where they were invited to attend two specific research visits for further data collection and biological research sampling. These research visits occurred at five (range 2-7) months and 12 (range 10-14) months post-discharge. Participants could also participate in specific nested studies (Tier 3) at selected sites.

All participants were asked to consent to further follow-up for 25 years via linkage to their electronic healthcare records and to be re-contacted for further research.

In total, 7935 participants were recruited from 83 UK sites: 5238 to Tier 1 and 2697 to Tier 2, between August 2020 and March 2022.

Cohort data are held in a Trusted Research Environment and samples stored in a central biobank. Data and samples can be accessed upon request and subject to approvals.

Competing Interest Statement

Full COI statement included in the submitted manuscript.

Clinical Protocols

https://www.phosp.org

Funding Statement

This work was supported by a joint funding from the UK Research and Innovation and National Institute of Health Research [grant references: MR/V027859/1 and COV0319]. The views expressed in the publication are those of the author(s) and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health and Social Care.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Leeds West Research Ethics Committee (20/YH/0225) and is registered on the ISRCTN Registry (ISRCTN10980107).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The PHOSP-COVID study website (https://www.phosp.org) contains an overview of the study, resources, information about people involved, and publications. Research activity using the study is organised across a series of Working Groups (Figure 3). These were established at the outset of the study to coordinate research, minimise duplication of efforts, and facilitate communication across research and clinical specialties. Researchers interested in undertaking research using PHOSP-COVID are encouraged to contact the relevant Working Group leads (https://www.phosp.org/working-group/) in the first instance. The data are currently held in the Outbreak Data Analysis Platform (ODAP, https://odap.ac.uk/). Researchers seeking to access these data are directed to https://www.phosp.org/resource/ for information and forms. Correspondence to be directed to Dr Rachael A Evans, the Co-Principal Investigator of PHOSP-COVID study phospleicester.ac.uk.

https://odap.ac.uk/

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