COVID-19LAURELNCT04628039
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs
An observational study of COVID-19 and Chronic Lung Diseases, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Chronic Lung Diseases
- How many people
- 622 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 May 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans aged 18 years or older who have a positive SARS-CoV-2 diagnosis (confirmed or presumptive) or who have been discharged home within 2 weeks to 1 year of diagnosis. Those who do not speak English or have cognitive limitations that preclude the ability to communicate and obtain informed consent will be excluded
Who may be able to join
- (Patients in COVID-19 cohort) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
- (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
- (Patients in LRTI cohort) VA patients diagnosed with LRTI and tested negative for COVID-19 (through PCR and/or antigen test)
Who cannot join
- Cognitive limitations that preclude the ability to communicate and obtain informed consent
- Language barriers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Official title: Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)
This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
Read the detailed description
The long-term consequences of COVID 19 are not well understood, particularly in the Veteran population. This study will describe and quantify the long-term consequences of COVID-19, including impairment in physical and psychosocial function and health-related quality of life. Additionally, it will determine the impact of chronic lung disease (CLD) and other comorbidities on severity and recovery after COVID-19 infection and the association of social determinants of health with severity and recovery.
Initially, a retrospective national cohort of VA patients who test positive with SARS2 will be identified. Baseline clinical history will be analyzed with outcomes that include severity of COVID 19, all-cause mortality, and post-discharge events.
Subsequently, a mixed methods, prospective cohort study will include both qualitative (interview) and quantitative components (surveys). The investigators will identify patients with COVID-19 and recruited for qualitative interviews following hospital discharge or diagnosis. Patient caregivers will also be eligible to participate in study interviews. Interviews will occur once at various times ranging 2 weeks to 1 year since a patient's COVID-19 diagnosis. Surveys will be completed at 3 time points, 2-8 weeks after diagnosis or discharge to home, and then 6 months and 12 months later. Surveys will include the EQ-5D-5L profile for health-related quality of life, and the WHODAS 2.0 score for a global assessment of overall physical and psychosocial function. Investigators will also identify a comparator cohort of patients who have been diagnosed with lower respiratory tract infection (LRTI) in the setting of a negative COVID-19 test. Surveys will be administered at the same interval and analysis will determine if COVID-19 has different and more severe health impacts than other causes of lower respiratory tract infection.
- Conditions
- COVID-19, Chronic Lung Diseases
- Keywords
- Chronic Lung Disease, COVID-19, Rehabilitation, Veterans, SARS-CoV-2, COPD
- Medical subject headings
- COVID-19, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| COVID Positive | Veterans aged 18 years or older who have a positive SARS-CoV-2 diagnosis (confirmed or presumptive) or who have been discharged home within 2 weeks to 1 year of diagnosis | |
| COVID Negative and Lower Respiratory Tract Infection (LRTI) | Veterans aged 18 years or older with a negative SARS-CoV-2 test (PCR and/or antigen test) and diagnosis of LRTI after discharge home or after diagnosis if not hospitalized |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score
Profile for health-related quality of life. The investigators will summarize this measure with a visual analog score (VAS). The VAS ranges from 0 to 100mm (where 0="the worst health you can imagine"; 100="the best health you can imagine").
Measured: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Global assessment of overall physical and psychosocial function. The overall score for disability will be calculated using item-response-theory (IRT) based scoring. This scale ranges from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index
Profile for health-related quality of life. We will summarize this measure with an overall utility index. The utility index ranges from less than 0 to 1(where <0="worse than death";1=full health).
Measured: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start27 May 2021
- Primary completion12 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kristina A Crothers, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628039
- Sponsor's protocol ID
- F3666-R
- Other IDs
- 1I01RX003666-01
- Acronym
- LAUREL
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2020
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner AP, Adams SV, Hawkins E, Fan VS, Nikzad R, Kundzins JR, Crothers K. Alcohol Use and COVID-19 Outcomes. Chest. 2025 Sep;168(3):589-601. doi: 10.1016/j.chest.2025.05.039. Epub 2025 Jun 10.
PubMed 40505809Petrova VV, Turner AP, Simons C, Kamiab NA, Crothers K, Sayre GG. Veterans' Experiences with COVID-19 and How Providers Can Shape Care and Perception with Empathy. J Gen Intern Med. 2025 May 15. doi: 10.1007/s11606-025-09557-9. Online ahead of print.
PubMed 40375042Crothers K, Adams SV, Turner AP, Batten L, Nikzad R, Kundzins JR, Fan VS. COVID-19 Severity and Mortality in Veterans with Chronic Lung Disease. Ann Am Thorac Soc. 2024 Jul;21(7):1034-1043. doi: 10.1513/AnnalsATS.202311-974OC.
PubMed 38530061
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)
- ClinicalTrials.gov ID
- NCT04628039
- Acronym / sponsor ID
- LAUREL / F3666-R
- Conditions
- COVID-19, Chronic Lung Diseases
- Keywords
- Chronic Lung Disease, COVID-19, Rehabilitation, Veterans, SARS-CoV-2, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 May 2021 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Nov 2020 (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.
This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
Detailed description
The long-term consequences of COVID 19 are not well understood, particularly in the Veteran population. This study will describe and quantify the long-term consequences of COVID-19, including impairment in physical and psychosocial function and health-related quality of life. Additionally, it will determine the impact of chronic lung disease (CLD) and other comorbidities on severity and recovery after COVID-19 infection and the association of social determinants of health with severity and recovery.
Initially, a retrospective national cohort of VA patients who test positive with SARS2 will be identified. Baseline clinical history will be analyzed with outcomes that include severity of COVID 19, all-cause mortality, and post-discharge events.
Subsequently, a mixed methods, prospective cohort study will include both qualitative (interview) and quantitative components (surveys). The investigators will identify patients with COVID-19 and recruited for qualitative interviews following hospital discharge or diagnosis. Patient caregivers will also be eligible to participate in study interviews. Interviews will occur once at various times ranging 2 weeks to 1 year since a patient's COVID-19 diagnosis. Surveys will be completed at 3 time points, 2-8 weeks after diagnosis or discharge to home, and then 6 months and 12 months later. Surveys will include the EQ-5D-5L profile for health-related quality of life, and the WHODAS 2.0 score for a global assessment of overall physical and psychosocial function. Investigators will also identify a comparator cohort of patients who have been diagnosed with lower respiratory tract infection (LRTI) in the setting of a negative COVID-19 test. Surveys will be administered at the same interval and analysis will determine if COVID-19 has different and more severe health impacts than other causes of lower respiratory tract infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID Positive | – | –Veterans aged 18 years or older who have a positive SARS-CoV-2 diagnosis (confirmed or presumptive) or who have been discharged home within 2 weeks to 1 year of diagnosis |
| COVID Negative and Lower Respiratory Tract Infection (LRTI) | – | –Veterans aged 18 years or older with a negative SARS-CoV-2 test (PCR and/or antigen test) and diagnosis of LRTI after discharge home or after diagnosis if not hospitalized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans aged 18 years or older who have a positive SARS-CoV-2 diagnosis (confirmed or presumptive) or who have been discharged home within 2 weeks to 1 year of diagnosis. Those who do not speak English or have cognitive limitations that preclude the ability to communicate and obtain informed consent will be excluded
Key inclusion criteria (3 listed)
- (Patients in COVID-19 cohort) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
- (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
- (Patients in LRTI cohort) VA patients diagnosed with LRTI and tested negative for COVID-19 (through PCR and/or antigen test)
Key exclusion criteria (2 listed)
- Cognitive limitations that preclude the ability to communicate and obtain informed consent
- Language barriers
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
EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score
Time frame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
Profile for health-related quality of life. The investigators will summarize this measure with a visual analog score (VAS). The VAS ranges from 0 to 100mm (where 0="the worst health you can imagine"; 100="the best health you can imagine").
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
Global assessment of overall physical and psychosocial function. The overall score for disability will be calculated using item-response-theory (IRT) based scoring. This scale ranges from 0 to 100 (where 0 = no disability; 100 = full disability).
EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index
Time frame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12
Profile for health-related quality of life. We will summarize this measure with an overall utility index. The utility index ranges from less than 0 to 1(where <0="worse than death";1=full health).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 40505809Turner AP, Adams SV, Hawkins E, Fan VS, Nikzad R, Kundzins JR, Crothers K. Alcohol Use and COVID-19 Outcomes. Chest. 2025 Sep;168(3):589-601. doi: 10.1016/j.chest.2025.05.039. Epub 2025 Jun 10.
- Derived from this study: PubMed 40375042Petrova VV, Turner AP, Simons C, Kamiab NA, Crothers K, Sayre GG. Veterans' Experiences with COVID-19 and How Providers Can Shape Care and Perception with Empathy. J Gen Intern Med. 2025 May 15. doi: 10.1007/s11606-025-09557-9. Online ahead of print.
- Derived from this study: PubMed 38530061Crothers K, Adams SV, Turner AP, Batten L, Nikzad R, Kundzins JR, Fan VS. COVID-19 Severity and Mortality in Veterans with Chronic Lung Disease. Ann Am Thorac Soc. 2024 Jul;21(7):1034-1043. doi: 10.1513/AnnalsATS.202311-974OC.
- 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. This study is not recruiting at the moment.
Kristina A Crothers, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Chronic Lung Diseases, run by VA Office of Research and Development at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score (time frame: Change in score from 3-8 weeks (after diagnosis or discharge to home) to months 6 and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628039, which also lists 3 linked publications.
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 22 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.