Quality of Life and Long-term Outcomes After Hospitalization for COVID-19
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04376658 |
Recruitment Status :
Completed
First Posted : May 6, 2020
Last Update Posted : July 6, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Quality of Life Long-term Outcomes Coronavirus Infection | Other: COVID-19 Severity |
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 |

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 |
- 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).
- 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.
- Incidence of rehospitalizations [ Time Frame: The outcome will be assessed 3, 6, 9 and 12 months after enrollment. ]Incidence of all-cause rehospitalizations.
- 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.
- 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).
- 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.
- 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.
- 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).
- 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).
- 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).
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376658
Brazil | |
Hospital Moinhos de Vento | |
Porto Alegre, Rio Grande Do Sul, Brazil |
Publications:
Responsible Party: | Hospital Moinhos de Vento |
ClinicalTrials.gov Identifier: | NCT04376658 |
Other Study ID Numbers: |
Coalition COVID-19: Long-term |
First Posted: | May 6, 2020 Key Record Dates |
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 |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Virus Diseases Infections |