Quality of Life and Long-term Outcomes After Hospitalization for COVID-19

Study Overview
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Brief Summary
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The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton & Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.

Official Title
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Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study

Conditions
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Quality of Life, Long-term Outcomes, Coronavirus Infection

Intervention / Treatment
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* Other: COVID-19 Severity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years and older Hospitalization due to proven or suspected SARS-CoV-2 infection Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials Exclusion Criteria: Death during the hospitalization Absence of telephone contact Absence of proxy for patients with communication difficulties Refusal or withdrawal of agreement to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 (Coalition I)<br>Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter. | Other: COVID-19 Severity<br>* Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death<br>|
| Cohort 2 (Coalition II)<br>Adult hospitalized patients with proven or suspected SARS-Cov-2 infection needing oxygen supplementation > 4L/min on nasal catheter or HFNC or NIV or MV or ECMO. | Other: COVID-19 Severity<br>* Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death<br>|
| Cohort 3 (Coalition III)<br>Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition | Other: COVID-19 Severity<br>* Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death<br>|
| Cohort 4 (Coalition IV)<br>Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range | Other: COVID-19 Severity<br>* Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death<br>|
| Cohort 5 (Coalition VI)<br>Adult hospitalized patients with proven SARS-Cov-2, needing oxygen supplementation to maintain SpO2 > 93%, and two or more of the following inflammatory tests: D-dimer > 1,000 ng/mL; C reactive protein (CRP) > 5 mg/dL; Ferritin > 300 mg/dL; Lactate dehydrogenase (LDH) > upper limit of normal | Other: COVID-19 Severity<br>* Disease severity characterized by the highest six-level ordinal scale during the hospital stay, which consists of the following categories: a score of 1 indicated not hospitalized; 2, hospitalized and not receiving supplemental oxygen; 3, hospitalized and receiving supplemental oxygen; 4, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 5, hospitalized and receiving mechanical ventilation; and 6, death<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year utility score of health-related quality of life | The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health). | The outcome will be assessed 12 months after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause mortality | Incidence of all-cause mortality. | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Incidence of rehospitalizations | Incidence of all-cause rehospitalizations. | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Percentage of return to work or study | Percentage of return to work or study among patients that were working or studying at the moment of hospitalization. | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Score of Instrumental Activities of Daily Living | The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence). | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Score of dyspnea | The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms. | The outcome will be assessed 3, 6, 9, and 12 months after enrollment. | 
| Percentage of long-term ventilatory support need | Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation. | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Symptoms of anxiety and depression | The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms). | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Symptoms of posttraumatic stress disorder | The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms). | The outcome will be assessed 3, 6, 9 and 12 months after enrollment. | 
| Utility score of health-related quality of life at 3, 6, and 9 months | The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health). | The outcome will be assessed 3, 6, and 9 months after enrollment. | 
| Score of self-rated health | The outcome will be assessed using the visual analogue scale of the Brazilian version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health). | The outcome will be assessed 3, 6, 9, and 12 months after enrollment. |