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Article History

Received: 20 August 2020

Accepted: 18 December 2020

First Online: 11 January 2021

Ethics approval and consent to participate

: The study will be conducted in accordance with the protocol, with the current version of the Declaration of Helsinki, ICH-GCP Guideline (International Conference on Harmonization - Good Clinical Practice), and applicable national laws and regulatory requirements.The VIGILung study EudraCT No.: 2019-001770-29Protocol version V03F, dated 05 November 2019 has been approved by the Ethics Committees of the Hannover Medical School, Germany (Nr. 8579_AMG_mono_2019) and the Medical University of Vienna (EK Nr.: 1127/2020) as well as by the German and Austrian Competent Authorities, Bundesinstitut für Arzneimittel und Medizinprodukte (Vorlage Nr. 4043539), and Bundesamt für Sicherheit im Gesundheitswesen BASG, reference 12760630 on 29 April 2020.Any substantial amendments to the protocol will be submitted to the EC in accordance with national requirements. Additional study sites may only recruit patients if the sponsor already obtained approval for the site.Written informed consent will be obtained from all participants in the trial before inclusion. The patient information and consent form was approved by the Ethics Committee of the Hannover Medical School and Medical University of Vienna. All patients after lung transplantation are followed in specialized follow-up clinics in participating centers. During the first visit after discharge from the hospital which is as early as 21 days after the surgical procedure, patients will be approached about the trial by transplant pulmonologists who are investigators of the trial. Informed consent of participants will also be obtained by transplant pulmonologists who are also investigators of the trial. Screening of patients will be discussed before the visit during team meetings. Patients have already been informed by newsletters, flyers in the waiting area, and social media. It is estimated to screen 250 patients to include 144 patients from screening procedures from previous trials. Any ancillary planned studies using patient data will be included in further informed consent forms of the trial. At this point, no ancillary studies are planned so far.

: The ethical approval and patient information include consent to publish the collected data.

: The authors declare to have no competing interests.