Research Project

Impact of COVID-19 infection in patients with alpha-1 antitrypsin deficiency

Principal Investigator:

David Parr

Center:

University Hospitals of Coventry and Warwickshire

City/Country:

Coventry (UK)

Start date:

June 2020

Status:

Finished, published

Contact E-mail:

david.parr@uhcw.nhs.uk

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Introduction

The evidence available to assess the level of risk and the outcome of infection with COVID-19 in AATD patients is extremely limited. Most patients with AATD have adhered to strict self-isolation and shielding practices, which has limited their exposure to COVID-19 and, as a direct consequence, the incidence of infection in this group of patients appears to have remained low. Sporadic reports of infection with COVID-19 in AATD patients would suggest that the early outcomes are not as poor as the AATD expert community would have predicted.
The IMCA1 study aims to collate information on clinician experience of COVID-19 infection in patients with AATD across the EU countries using a pre-existing consortium of AATD researchers (EARCO) that is supported by the European Respiratory Society.

Objectives

Primary objective
To provide a description of the incidence and outcomes in patients with AATD who are known to have been, or suspected to have been, infected with COVID-19.

Secondary objectives
To establish whether further research is required on the effects of COVID-19 in patients with AATD.

Inclusion criteria

Adult patients (over 18 years of age) with AATD (PiZZ, PiSZ and other rare variants with AAT level <11micromolar) who have been identified by their national / regional AATD centre as having been infected with COVID-19 (either proven with microbiological or serological testing, or with a clinical diagnosis of COVID-19).

Brief summary

Data will be sourced from routine clinical records. There will be no study visits or investigations performed. Anonymised clinical data will be entered into an electronic Case Report Form. Patient identifiable data will only be visible to the direct clinical care team

Patients will be identified by participating centres using audit of clinical coding records and electronic clinical records. AATD patients will self-report to the site coordinator if they have not attended the hospital for management of an episode of COVID-19 infection.

Data will be obtained from assessments obtained as part of routine clinical management. No follow-up will be conducted.