Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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)

Exclusion criteria

Cognitive limitations that preclude the ability to communicate and obtain informed consent
Language barriers

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study)

Acronym: LAUREL

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Nov 13, 2020
Registry last updated: Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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