Home monitoring and molecular profiling of patients with long COVID focusing on lung issues
Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement
This study is testing a mobile app to help people with long COVID and lung problems track their symptoms and understand the biological reasons behind their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Sverige) |
| Trial ID | NCT05894616 on ClinicalTrials.gov |
What this trial studies
This project aims to characterize and sub-phenotype patients suffering from post-acute COVID syndrome (PACS) with a particular emphasis on lung involvement. Utilizing a mobile application called HemCOV, patients will engage in home monitoring through questionnaires and spirometry assessments to gather clinical and molecular data. The study will explore the biological mechanisms underlying PACS by correlating clinical phenotyping with multi-molecular level omics data. The research will also investigate sex differences in patients with lung involvement to better understand the etiology of the condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have experienced verified SARS-CoV-2 infections and have persistent symptoms related to lung involvement for more than 12 weeks.
Not a fit: Patients who had severe COVID-19 requiring hospitalization during their initial infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and targeted treatments for patients suffering from long COVID, particularly those with lung complications.
How similar studies have performed: While the approach of using home monitoring and molecular profiling is innovative, similar studies have shown promise in understanding post-viral syndromes, making this a potentially valuable endeavor.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: Chronic disease other than asthma. Asthma diagnosis after 2020 allowed in the PASC group. \-
Where this trial is running
Stockholm, Sverige
- Karolinska Institutet/Karolinska University Hospital Solna — Stockholm, Sverige, Sweden (Recruiting)
Study contacts
- Principal investigator: Asa M. Wheelock, PhD — Karolinska Institutet
- Study coordinator: Asa M. Wheelock, PhD
- Email: asa.wheelock@ki.se
- Phone: +46702200308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.