Status:
COMPLETED
Lung Function, Exercise Capacity and Health-Related Quality of Life After Severe COVID-19
Lead Sponsor:
Federal University of Rio Grande do Sul
Collaborating Sponsors:
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
COVID-19
SARS-CoV-2 Infection
Eligibility:
All Genders
Brief Summary
Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe disease requiring hospitalization and oxygen suppor...
Detailed Description
Background: Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2) that was first rec...
Eligibility Criteria
Inclusion
- Previous laboratory confirmation of SARS-Cov-2 infection defined as a positive result of reverse polymerase-transcriptase chain reaction test in real-time of a sample taken by nasal and/or pharyngeal swab; and
- Severe pneumonia defined by the presence of fever or suspected lower respiratory infection, plus one of the following criteria: respiratory rate\> 30 movements/min; severe respiratory distress; SpO2≤93% in room air; or pulmonary infiltrates\>50% on chest imaging within 24-48hrs of acute symptoms onset; and/or
- Acute respiratory distress syndrome (ARDS) defined according to COVID-19 operational management guide of World Health Organization and classified as mild (200 mmHg \<PaO2 / FiO2 ≤ 300 mmHg), moderate (100 mmHg \<PaO2 / FiO2 ≤ 200 mmHg) or severe (PaO2 / FiO2 ≤ 100 mmHg). When the PaO2 is not available, SpO2 / FiO2 ≤ 315 suggests ARDS.
Exclusion
- Lack of clinical stability for 2 months before inclusion (including those who remain hospitalized);
- Active respiratory tract infection (of any cause); or
- Any clinical condition that prevents the performance of the study procedures.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04410107
Start Date
May 15 2020
End Date
July 30 2023
Last Update
December 4 2023
Active Locations (5)
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1
Universidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil, 99052-900
2
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
3
Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
4
Univesidade de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170