NCT05894616Recruiting
Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 7 Jun 2023
- Start date
- 21 Nov 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05894616
What you commit to
- Study type: Observational
- Planned participants: 100
- From 21 Nov 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic disease other than asthma. Asthma diagnosis after 2020 allowed in the PASC group.
Other
- \-
Who the study is looking for
- PASC group (n=50): Verified SARS-CoV-2 infections (PCR or serology prior to vaccination) during wave 1 and 2 (prior to 2021-02-28). Symptoms \>12 weeks after initial illness but with mild-to-moderate disease that did not require hospitalization during the initial infection, disabling persistent symptoms that at some point has affect work capacity 50%. Focus in this study will be placed on subject with some level of lung involvement, including but not limited to Air-trapping on HRCT images, ground glass alterations in radiology, airway obstruction, or shortness of breath as defined by CAT. Experience of dyspnea (mMRC\>3 within past 2 weeks) is a required inclusion criteria, with the addition of one of the following: lung obstruction (FEv1/FVC\>70 or Z-score \< -1.64), lung restriction (FEV1\<80% or FVC \< 80%, air-trapping, ground glass- or mosaic attenuation observed by HRCT.
- Health control group (n=50): Confirmed SARS-CoV-2 infection during wave 1 or 2. Fully recovered within 12 weeks of primary infection.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet/Karolinska University Hospital Solna Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.