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

• ClinicalTrials.gov Identifier: NCT04376658
• Recruitment Status: Completed
• First Posted: May 6, 2020
• Last Update Posted: July 6, 2022
• Sponsor: Hospital Moinhos de Vento
• Collaborators: Hospital Israelita Albert Einstein; Hospital Sirio-Libanes; Hospital do Coracao; Hospital Alemão Oswaldo Cruz; Beneficência Portuguesa de São Paulo; Brazilian Clinical Research Institute; Brazilian Research In Intensive Care Network
• Information provided by (Responsible Party): Hospital Moinhos de Vento

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Quality of Life; Long-term Outcomes; Coronavirus Infection	Other: COVID-19 Severity

Study Design

• Study Type: Observational
• Actual Enrollment: 1508 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Health-related Quality of Life and Long-term Outcomes After Hospitalization for COVID-19: A Multicenter Prospective Cohort Study
• Actual Study Start Date: July 15, 2020
• Actual Primary Completion Date: March 11, 2022
• Actual Study Completion Date: March 11, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cohort 1 (Coalition I); 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; 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
Cohort 2 (Coalition II); 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; 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
Cohort 3 (Coalition III); 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; 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
Cohort 4 (Coalition IV); Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range	Other: COVID-19 Severity; 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
Cohort 5 (Coalition VI); 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; 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

Outcome Measures

Primary Outcome Measures :

1. One-year utility score of health-related quality of life [ Time Frame: The outcome will be assessed 12 months after enrollment. ]
   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).

Secondary Outcome Measures :

1. Incidence of all-cause mortality [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   Incidence of all-cause mortality.
2. Incidence of rehospitalizations [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   Incidence of all-cause rehospitalizations.
3. Percentage of return to work or study [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   Percentage of return to work or study among patients that were working or studying at the moment of hospitalization.
4. Score of Instrumental Activities of Daily Living [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   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).
5. Score of dyspnea [ Time Frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment. ]
   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.
6. Percentage of long-term ventilatory support need [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation.
7. Symptoms of anxiety and depression [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   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).
8. Symptoms of posttraumatic stress disorder [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]
   The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms).
9. Utility score of health-related quality of life at 3, 6, and 9 months [ Time Frame: The outcome will be assessed 3, 6, and 9 months after enrollment. ]
   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).
10. Score of self-rated health [ Time Frame: The outcome will be assessed 3, 6, 9, and 12 months after enrollment. ]
    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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection

Criteria

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

Contacts and Locations

Locations

Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande Do Sul, Brazil

Sponsors and Collaborators

Hospital Moinhos de Vento

Hospital Israelita Albert Einstein

Hospital Sirio-Libanes

Hospital do Coracao

Hospital Alemão Oswaldo Cruz

Beneficência Portuguesa de São Paulo

Brazilian Clinical Research Institute

Brazilian Research In Intensive Care Network

More Information

Additional Information:

Study Protocol 

Publications:

Rosa RG, Robinson CC, Veiga VC, Cavalcanti AB, Azevedo LCP, Machado FR, Berwanger O, Avezum A, Lopes RD, Lisboa TC, Teixeira C, Zampieri FG, Tomazini BM, Kawano-Dourado L, Schneider D, Souza D, Santos RDRMD, Silva SSD, Trott G, Gimenes BDP, Souza AP, Barroso BM, Costa LS, Brognoli LG, Pelliccioli MP, Studier NDS, Schardosim RFC, Haubert TA, Pallaoro VEL, Oliveira DM, Velho PI, Medeiros GS, Gazzana MB, Zavascki AP, Pitrez PM, Oliveira RP, Polanczyk CA, Nasi LA, Hammes LS, Falavigna M. Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII). Rev Bras Ter Intensiva. 2021 Jan-Mar;33(1):31-37. doi: 10.5935/0103-507X.20210003.

• Responsible Party: Hospital Moinhos de Vento
• ClinicalTrials.gov Identifier: NCT04376658
• Other Study ID Numbers: Coalition COVID-19: Long-term
• First Posted: May 6, 2020
• Last Update Posted: July 6, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections