Clinical trial NCT05225194: Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
ARDS
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diffusion capacity for carbon monoxide
timeFrame: The outcome will be assessed 6 months after enrollment
Secondary outcomes:
measure: Physical functional status
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Instrumental Activities of Daily Living
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Muscular function and strength
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Score of dyspnea
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Utility score of health related quality of life
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Radiologic patterns of intersticial lung disease
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Radiologic patterns of myocarditis sequalae
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Radiologic patterns of sarcopenia
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Incidence of major cardiovascular events
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Incidence of thromboembolic events
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Incidence of all-cause mortality
timeFrame: The outcome will be assessed at 3 and 6 months after enrollment
measure: Percentage of predicted peak oxygen consumption
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Peak oxygen consumption
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Peak oxygen pulse
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Oxygen uptake efficiency slope
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Minute ventilation/carbon dioxide production slope ratio
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Forced vital capacity
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Forced expiratory volume in one second
timeFrame: The outcome will be assessed at 6 months after enrollment
measure: Forced expiratory volume in one second/ Forced vital capacity ratio
timeFrame: The outcome will be assessed at 6 months after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Moinhos de Vento
name: Regis G Rosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: