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

NCT05894616 | Recruiting DMC

• 1 other identifier: 2022-03768-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Long COVID

Outcome Measures

Primary Outcomes (4)

• Home monitoring of health status using the eHealth tool HemCOV

  Home monitoring of symptoms, perceived activity level and actual activity level

  5 weeks

• Asthma evaluation using AsthmaTuner

  Spirometry, reversibility test in clinic, followed by FEV1, PEF and variability evaluation using home spirometry

  2 weeks

• Molecular characterization of particles in exhaled air (PExA)

  Collection of PExA material and evaluation of miRNA and proteomes in PEx material

  2 years

• Molecular characterization of samples from the lung collected through bronchoscopy

  Analysis of mRNA, miRNA, proteomes, metabolomes, oxylipins and microbiomes from several anatomical locations in the lung

  2 years

Study Arms (2)

Post acute sequale of COVID-19 (PASC)

Verified infection with SARS-CoV-2 during wave 1 and 2 (i.e. wild type or alfa variants), prior to 2021-02-28. Diagnosed with post-COVID. 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.

Healthy control recovered from COVID-19

Verified infection with SARS-CoV-2 during wave 1 and 2 (i.e. wild type or alfa variants), prior to 2021-02-28. Fully recovered within 12 weeks of primary infection. No other diagnoses.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

See inclusion and exclusion criteria above.

You may qualify if:

• Health control group (n=50): Confirmed SARS-CoV-2 infection during wave 1 or 2. Fully recovered within 12 weeks of primary infection.

You may not qualify if:

• Chronic disease other than asthma. Asthma diagnosis after 2020 allowed in the PASC group.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Michael Runold (Clinical lead), MD, PhD: collaborator
• Kristina Piontkovskaya, MD, PhD: collaborator
• Björn Nordlund, RN, PhD: collaborator
• Angelica Lindén Hirschberg, MD, PhD: collaborator
• Tobias Granberg, MD, PhD: collaborator
• Karolinska University Hospital: collaborator
• Swedish Heart Lung Foundation: collaborator
• The Swedish Research Council: collaborator
• AsthmaTuner AB: collaborator

Study Sites (1)

Karolinska Institutet/Karolinska University Hospital Solna

Stockholm, Sverige, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Asa M. Wheelock, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asa M. Wheelock, PhD

CONTACT

+46702200308; asa.wheelock@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Respiratory Medicine Unit; PhD in Pharmacology and Toxicology

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 8, 2023
• Study Start: November 21, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2037
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)