Home monitoring and molecular profiling of patients with long COVID focusing on lung issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

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Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.