Long COVIDHemCOVNCT05894616
Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement
An observational study of Long COVID, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 21 Nov 2022to 31 Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: See inclusion and exclusion criteria above.
Who may be able to join
- 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.
Who cannot join
- Chronic disease other than asthma. Asthma diagnosis after 2020 allowed in the PASC group.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet/Karolinska University Hospital Solna
Stockholm, Sverige, 17176
Asa Wheelock, PhD, +46702200308, asa.wheelock@ki.se
Asa M Wheelock, PhD, asa.wheelock@ki.se
About this study
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.
Read the detailed description
The core of the home monitoring study is a mobile Application recently developed by our research group. The App, termed HemCOV, is developed on the MyCap/REDCap platformed that is GDPR approved, and is installed on the research subjects (RS) own mobile phone during Visit 1 (virtual visit). The RS will also be assisted in initiate a wearable activity monitor. The RS is then triggered by the App first to answer a set of questionnaires related to health both prior to COVID infection, and currently. Given frequent fatigue among PASC patients, the RS is given 3 days to complete this first task. Thereafter the RS is triggered by the App to answer a brief set of questions daily for 1 weeks to establish a baseline of wellbeing. The RS is then called to Visit 2 which entails spirometry, as well as initiation of a 2 week evaluation using AsthmaTuner (AT). AT triggers the RS to perform spirometry with a portable home spirometer daily. The HemCOV and AsthmaTuner Apps are run daily in parallel for a week. The HemCOV App is the reduced to once every 3 days during the rest of the study to avoid cognitive overload. Initiated and developed by B. Nordlund research group at the Karolinska Institute and Astrid Lindgren Children's Hospital, with support from Swedish innovation programs, AsthmaTuner facilitate asthma diagnosis 7. Given that a number of PASC patients report having been diagnosed with asthma after their initial COVID diagnosis without having been properly investigated, this particular aspect of the AsthmaTuner system is of great interest. In addition, it allows us to follow and identify any alterations in lung function associated with reported alterations in wellbeing, energy levels, or worsening of any PASC-associated symptoms such as fatigue, brain fog, shortness of breath etc. The spirometry registers forced expiratory volume in 1 s (FEV1) and FEV6 (an approximation of forced vital capacity [FVC], to enable the calculation of the ratio that is the basis for measuring lung obstruction (FEV1 / FVC). Visit 3 includes a physical exam by physician to assure the RS is fit to undergo bronchoscopy. If CT has not yet been performed, the RS will also undergo a chest X-ray at this point. In week 4, non-invasive sampling of PExA, blood and urine is performed during Visit 4, and finally in Visit 5 two days later the RS will undergo bronchoscopy, which includes sampling of bronchial epithelial cells (BEC), and immune cells and airway exudates through bronchoalveolar lavage (BAL). Blood hormone profiles to allow investigation of hormone related gender differences in PASC are also performed (lead by endocrinologist prof. Angelica Lindén Hirschberg). Finally at Visit 6, the diffusion capacity is determined. All sample workup and storage of biospecimens will be performed in-house under direct supervision of the PI, utilizing standardized operating procedures (SOP) identical to those utilized in our previous studies, where sample integrity and quality has been confirmed for all omics platforms. Following completion of the base study, participants will be invited for follow-ups after 1, 2, 5 and 10 years. The followup visits include the App questions and questionnaires included in the base study, as well as sampling of blood, urine and PExA.
- Conditions
- Long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home monitoring of health status using the eHealth tool HemCOV
Home monitoring of symptoms, perceived activity level and actual activity level
Measured: 5 weeks
Asthma evaluation using AsthmaTuner
Spirometry, reversibility test in clinic, followed by FEV1, PEF and variability evaluation using home spirometry
Measured: 2 weeks
Molecular characterization of particles in exhaled air (PExA)
Collection of PExA material and evaluation of miRNA and proteomes in PEx material
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start21 Nov 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Michael Runold (Clinical lead), MD, PhD, Kristina Piontkovskaya, MD, PhD, Björn Nordlund, RN, PhD, Angelica Lindén Hirschberg, MD, PhD, Tobias Granberg, MD, PhD, Karolinska University Hospital, Swedish Heart Lung Foundation, The Swedish Research Council, AsthmaTuner AB
- Responsible party
- Principal investigator, Asa Wheelock, Karolinska Institutet
- Investigators
- Asa M. Wheelock, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894616
- Sponsor's protocol ID
- 2022-03768-01
- Acronym
- HemCOV
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring and Molecular Phenotyping of Patients With Post-COVID With Focus on Lung Involvement
- ClinicalTrials.gov ID
- NCT05894616
- Acronym / sponsor ID
- HemCOV / 2022-03768-01
- Conditions
- Long COVID
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Michael Runold (Clinical lead), MD, PhD, Kristina Piontkovskaya, MD, PhD, Björn Nordlund, RN, PhD, Angelica Lindén Hirschberg, MD, PhD, Tobias Granberg, MD, PhD, Karolinska University Hospital, Swedish Heart Lung Foundation, The Swedish Research Council, AsthmaTuner AB
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The core of the home monitoring study is a mobile Application recently developed by our research group. The App, termed HemCOV, is developed on the MyCap/REDCap platformed that is GDPR approved, and is installed on the research subjects (RS) own mobile phone during Visit 1 (virtual visit). The RS will also be assisted in initiate a wearable activity monitor. The RS is then triggered by the App first to answer a set of questionnaires related to health both prior to COVID infection, and currently. Given frequent fatigue among PASC patients, the RS is given 3 days to complete this first task. Thereafter the RS is triggered by the App to answer a brief set of questions daily for 1 weeks to establish a baseline of wellbeing. The RS is then called to Visit 2 which entails spirometry, as well as initiation of a 2 week evaluation using AsthmaTuner (AT). AT triggers the RS to perform spirometry with a portable home spirometer daily. The HemCOV and AsthmaTuner Apps are run daily in parallel for a week. The HemCOV App is the reduced to once every 3 days during the rest of the study to avoid cognitive overload. Initiated and developed by B. Nordlund research group at the Karolinska Institute and Astrid Lindgren Children's Hospital, with support from Swedish innovation programs, AsthmaTuner facilitate asthma diagnosis 7. Given that a number of PASC patients report having been diagnosed with asthma after their initial COVID diagnosis without having been properly investigated, this particular aspect of the AsthmaTuner system is of great interest. In addition, it allows us to follow and identify any alterations in lung function associated with reported alterations in wellbeing, energy levels, or worsening of any PASC-associated symptoms such as fatigue, brain fog, shortness of breath etc. The spirometry registers forced expiratory volume in 1 s (FEV1) and FEV6 (an approximation of forced vital capacity [FVC], to enable the calculation of the ratio that is the basis for measuring lung obstruction (FEV1 / FVC). Visit 3 includes a physical exam by physician to assure the RS is fit to undergo bronchoscopy. If CT has not yet been performed, the RS will also undergo a chest X-ray at this point. In week 4, non-invasive sampling of PExA, blood and urine is performed during Visit 4, and finally in Visit 5 two days later the RS will undergo bronchoscopy, which includes sampling of bronchial epithelial cells (BEC), and immune cells and airway exudates through bronchoalveolar lavage (BAL). Blood hormone profiles to allow investigation of hormone related gender differences in PASC are also performed (lead by endocrinologist prof. Angelica Lindén Hirschberg). Finally at Visit 6, the diffusion capacity is determined. All sample workup and storage of biospecimens will be performed in-house under direct supervision of the PI, utilizing standardized operating procedures (SOP) identical to those utilized in our previous studies, where sample integrity and quality has been confirmed for all omics platforms. Following completion of the base study, participants will be invited for follow-ups after 1, 2, 5 and 10 years. The followup visits include the App questions and questionnaires included in the base study, as well as sampling of blood, urine and PExA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- See inclusion and exclusion criteria above.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Chronic disease other than asthma. Asthma diagnosis after 2020 allowed in the PASC group.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Home monitoring of health status using the eHealth tool HemCOV
Time frame: 5 weeks
Home monitoring of symptoms, perceived activity level and actual activity level
Asthma evaluation using AsthmaTuner
Time frame: 2 weeks
Spirometry, reversibility test in clinic, followed by FEV1, PEF and variability evaluation using home spirometry
Molecular characterization of particles in exhaled air (PExA)
Time frame: 2 years
Collection of PExA material and evaluation of miRNA and proteomes in PEx material
Molecular characterization of samples from the lung collected through bronchoscopy
Time frame: 2 years
Analysis of mRNA, miRNA, proteomes, metabolomes, oxylipins and microbiomes from several anatomical locations in the lung
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asa M. Wheelock, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asa M. Wheelock, PhD (+46702200308, asa.wheelock@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home monitoring of health status using the eHealth tool HemCOV (time frame: 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.