Actively Recruiting
Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement
Led by Karolinska Institutet · Updated on 2025-04-01
100
Participants Needed
1
Research Sites
788 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
M
Michael Runold (Clinical lead), MD, PhD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years
- Verified SARS-CoV-2 infection before 2021-02-28 (PCR or serology before vaccination)
- Symptoms lasting more than 12 weeks after initial illness
- Mild-to-moderate initial COVID-19 not requiring hospitalization
- Disabling persistent symptoms affecting work capacity by at least 50%
- Lung involvement such as air-trapping on HRCT, ground glass changes, airway obstruction, or shortness of breath
- Dyspnea with mMRC score greater than 3 within past 2 weeks
- At least one of the following: lung obstruction (FEV1/FVC >70 or Z-score < -1.64), lung restriction (FEV1 <80% or FVC <80%), air-trapping, or specific HRCT findings
- For healthy controls: confirmed SARS-CoV-2 infection during waves 1 or 2 and full recovery within 12 weeks
You will not qualify if you...
- Chronic diseases other than asthma
- Asthma diagnosis after 2020 allowed only in PASC group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karolinska Institutet/Karolinska University Hospital Solna
Stockholm, Sverige, Sweden, 17176
Actively Recruiting
Research Team
A
Asa M. Wheelock, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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