Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement

NCT05894616 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-04-01

No results posted yet for this study

Summary

Post-acute COVID syndrome (PACS) /post-acute sequale of COVID-19 (PASC) / post-COVID is a novel clinical syndrome with unknown biological mechanisms, and to date no standard-of-care, routines for follow-up, or evidence-based treatments have been established. In this project, we will employ a systems medicine approach to identify pathways and networks of genes, proteins and metabolites that are critical in disease onset and progression, towards the goal of understanding specific mechanisms in the etiology of PASC.

The objective of the project is to perform clinical and molecular characterization and sub-phenotyping of patients with PASC, (a.k.a. PACS, or post-COVID), into mechanistically relevant groups, with focus on sex differences in patients with lung involvement. Molecular pathways involved in disease etiology will be identified by correlating rigorous clinical phenotyping and longitudinal eHealth data (home-monitoring via App, home spirometer etc), with multi-molecular level omics profiling of samples collected from the lung, integrated with our systems medicine framework. Aim I involves longitudinal home-monitoring at baseline to investigate fluctuations in general wellbeing, and causes thereof, in PASC patients with lung involvement compared to healthy controls. In Aim II, a set of omics technologies will be employed to provide in-depth molecular characterization of samples from the lung, exhaled particles (PExA), blood and urine. In depth clinical characterizations including photon-counting CT will be performed. In Aim III, integrative statistical- and network modeling approaches will be utilized to: i) identify molecularly distinct sub-groups of obstructive lung diseases based on multi-molecular level network-integration, and ii) identify individual mediators and molecular pathways related to clinical phenotype including longitudinal home-monitoring data, prognosis, diagnosis, and disease etiology of the identified sub-groups.

Conditions

Sponsors & Collaborators

  • Michael Runold (Clinical lead), MD, PhD

    collaborator UNKNOWN
  • Kristina Piontkovskaya, MD, PhD

    collaborator UNKNOWN
  • Björn Nordlund, RN, PhD

    collaborator UNKNOWN
  • Angelica Lindén Hirschberg, MD, PhD

    collaborator UNKNOWN
  • Tobias Granberg, MD, PhD

    collaborator UNKNOWN
  • Karolinska University Hospital

    collaborator OTHER
  • Swedish Heart Lung Foundation

    collaborator OTHER
  • The Swedish Research Council

    collaborator OTHER_GOV
  • AsthmaTuner AB

    collaborator UNKNOWN
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Asa M. Wheelock, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2027-12-31
Completion
2037-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894616 on ClinicalTrials.gov