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

Hospital Moinhos de Vento

Status: Completed

Conditions: Quality of Life; Long-term Outcomes; Coronavirus Infection

Treatments: Other: COVID-19 Severity

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT04376658

Coalition COVID-19: Long-term

Details and patient eligibility

About

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.

Enrollment: 1,508 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,508 participants in 5 patient groups

Cohort 1 (Coalition I)

Description:

Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with up to 4L/minute oxygen supply through nasal catheter.

Treatment:

Other: COVID-19 Severity

Cohort 2 (Coalition II)

Description:

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.

Treatment:

Other: COVID-19 Severity

Cohort 3 (Coalition III)

Description:

Adult hospitalized patients with proven or suspected SARS-Cov-2 infection with moderate or severe ARDS according to the Berlin definition

Treatment:

Other: COVID-19 Severity

Cohort 4 (Coalition IV)

Description:

Adult hospitalized patients with proven SARS-Cov-2 infection and D-dimer above the upper limit of the normal range

Treatment:

Other: COVID-19 Severity

Cohort 5 (Coalition VI)

Description:

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

Treatment:

Other: COVID-19 Severity