Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil

COVID-19 Clinical Trial

Official title:

Prospective Study for the Assessment of Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05225194
• Other study ID #: Pos-COVID Brasil 3
• Status: Not yet recruiting
• Start date: February 15, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2022
• Source: Hospital Moinhos de Vento
• Contact: Geraldine Trott, PhD
• Phone: +5551994407117
• Email: geraldine.trott[@]hmv.org.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS).

This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 318
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19

Inclusion Criteria:

• Age =18 years;

• Hospitalization due to COVID-19;

• Positive polymerase chain reaction (PCR) test for SARS-CoV-2;

• Diagnosis of ARDS during hospitalization according to the Berlin definition;

• Expected to survive and be discharged directly home from the hospital.

Exclusion Criteria:

• Severe comorbidity with life expectancy less than 3 months;

• Unavailability to attend the study follow-up appointment;

• Death during hospitalization;

• Absence of proxy for patients with communication difficulties;

• Refusal or withdrawal of agreement to participate.

COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19

Inclusion Criteria:

• Age =18 years;

• Hospitalization;

• Diagnosis of ARDS during hospitalization according to the Berlin definition;

• Expected to survive and be discharged directly home from the hospital.

Exclusion Criteria:

• Severe comorbidity with life expectancy less than 3 months;

• Unavailability to attend the study follow-up appointment;

• Death during hospitalization;

• History of SARS-CoV-2 infection within the last 12 months;

• Absence of proxy for patients with communication difficulties;

• Refusal or withdrawal of agreement to participate.

FAMILY CONTROLS

Inclusion Criteria:

• Age =18 years;

• Family member of a enrolled participant (either from the COVID-19 ARDS cohort or from the non-COVID-19 ARDS cohort)

Exclusion Criteria:

• Severe comorbidity with life expectancy less than 3 months;

• Unavailability to attend the study follow-up appointment;

• History of SARS-CoV-2 infection within the last 12 months;

• History of non-elective hospitalization due to medical condition within the last 12 months;

• Refusal or withdrawal of agreement to participate.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• COVID-19
SARS-CoV-2 infection
• ARDS
Acute respiratory distress syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion capacity for carbon monoxide	Proportion of participants with diffusion capacity for carbon monoxide < 80% of predicted	The outcome will be assessed 6 months after enrollment
Secondary	Physical functional status	Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence)	The outcome will be assessed at 3 and 6 months after enrollment
Secondary	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 at 3 and 6 months after enrollment
Secondary	Muscular function and strength	Muscular function and strength as assessed by Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. Scale scores range from 0 (best) to 10 (worst)	The outcome will be assessed at 3 and 6 months after enrollment
Secondary	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 at 3 and 6 months after enrollment
Secondary	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 at 3 and 6 months after enrollment
Secondary	Radiologic patterns of intersticial lung disease	Radiologic patterns of intersticial lung disease as assessed by high resolution computed tomography chest scan.	The outcome will be assessed at 6 months after enrollment
Secondary	Radiologic patterns of myocarditis sequalae	Radiologic patterns of myocarditis sequalae as assessed by cardiac magnetic resonance imaging	The outcome will be assessed at 6 months after enrollment
Secondary	Radiologic patterns of sarcopenia	Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan.	The outcome will be assessed at 6 months after enrollment
Secondary	Incidence of major cardiovascular events	Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death)	The outcome will be assessed at 3 and 6 months after enrollment
Secondary	Incidence of thromboembolic events	Incidence of thromboembolic events (composite endpoint of pulmonary embolism and deep venous thrombosis)	The outcome will be assessed at 3 and 6 months after enrollment
Secondary	Incidence of all-cause mortality	Incidence of all-cause mortality	The outcome will be assessed at 3 and 6 months after enrollment
Secondary	Percentage of predicted peak oxygen consumption	Percentage of predicted peak oxygen consumption as assessed by treadmill cardiopulmonary exercise cardiopulmonary exercise	The outcome will be assessed at 6 months after enrollment
Secondary	Peak oxygen consumption	Peak oxygen as assessed by treadmill cardiopulmonary exercise	The outcome will be assessed at 6 months after enrollment
Secondary	Peak oxygen pulse	Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise	The outcome will be assessed at 6 months after enrollment
Secondary	Oxygen uptake efficiency slope	Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise	The outcome will be assessed at 6 months after enrollment
Secondary	Minute ventilation/carbon dioxide production slope ratio	Minute ventilation/carbon dioxide production slope as assessed by treadmill cardiopulmonary exercise	The outcome will be assessed at 6 months after enrollment
Secondary	Forced vital capacity	Forced expiratory capacity as assessed by spirometry	The outcome will be assessed at 6 months after enrollment
Secondary	Forced expiratory volume in one second	Forced expiratory volume in one second as assessed by spirometry	The outcome will be assessed at 6 months after enrollment
Secondary	Forced expiratory volume in one second/ Forced vital capacity ratio	Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry	The outcome will be assessed at 6 months after enrollment