## Protocol Section
### Identification Module
**NCT ID:** NCT05165979

**Brief Title:** Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil

**Official Title:** Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil

#### Organization Study ID Info
**ID:** Pos-COVID Brasil 1
#### Organization
**Class:** OTHER
**Full Name:** Hospital Moinhos de Vento
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-03

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12-21

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2021-12-21
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-20
**Study First Submit QC Date:** 2021-12-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Moinhos de Vento

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.

### Conditions Module

**Conditions:**

- COVID-19

- Quality of Life

- Disability Physical

- Disabilities Mental

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 650

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Hospitalized COVID-19 patients

**Intervention Names:**

- Other: Hospitalization due to COVID-19

**Label:** Hospitalized COVID-19 patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hospitalized COVID-19 patients

**Description:** Hospitalization due to COVID-19

**Name:** Hospitalization due to COVID-19

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire.

**Measure:** One-year utility score of health related quality of life

**Time Frame:** The outcome will be assessed 12 months after enrollment.

#### Secondary Outcomes

**Description:** 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).

**Measure:** Utility score of health related quality of life at 3, 6, and 9 months

**Time Frame:** The outcome will be assessed at 3, 6, and 9 months after enrollment.

**Description:** Incidence of all-cause mortality

**Measure:** Incidence of all-cause mortality

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death)

**Measure:** Incidence of major cardiovascular events

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Incidence of all-cause rehospitalizations

**Measure:** Incidence of rehospitalizations

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Prevalence of prolonged COVID-19 symptoms defined as presence of dyspnea, cough, fatigue, muscular weakness, chest discomfort, joint pain, anosmia, hair loss, brain fog, insomnia, among others)

**Measure:** Prevalence of prolonged COVID-19 symptoms

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Prevalence of cognitive dysfunction as assessed by the Telephone Interview for Cognitive Status (TICS-m; scores ranging from 0 to 50 with lower scores indicating worse cognition).

**Measure:** Prevalence of cognitive dysfunction

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Prevalence of anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).

**Measure:** Prevalence of anxiety and depression symptoms

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Prevalence of posttraumatic stress disorder symptoms as assessed by the Impact Event Scale-6 (scores range from 0 to 24 with higher scores indicating worse symptoms).

**Measure:** Prevalence of posttraumatic stress disorder symptoms

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence).

**Measure:** Physical functional status

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** 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).

**Measure:** Instrumental Activities of Daily Living

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Incidence of return to work or study among patients that were working or studying at the moment of hospitalization.

**Measure:** Incidence of return to work or study

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

**Description:** Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection.

**Measure:** Incidence of new symptomatic COVID-19 infection

**Time Frame:** The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥18 years;
* Symptomatic COVID-19 disease within the last 14 days;
* Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
* Need of hospitalization (duration ≥ 48 hours).

Exclusion Criteria:

* Severe comorbidity with life expectancy less than 3 months;
* Death during hospitalization;
* Absence of telephone contact;
* Absence of proxy for patients with communication difficulties;
* Refusal or withdrawal of agreement to participate;
* Previous enrollment in the study.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients survivors of hospitalization due to proven COVID-19 disease.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Belo Horizonte

**Country:** Brazil

**Facility:** Hospital das clínicas da UFMG

**State:** MG

**Location 2:**

**City:** Belo Horizonte

**Country:** Brazil

**Facility:** Hospital Emydio Germano

**State:** MG

**Location 3:**

**City:** Belo Horizonte

**Country:** Brazil

**Facility:** Hospital Metropolitano Célio de Castro

**State:** MG

**Location 4:**

**City:** Belo Horizonte

**Country:** Brazil

**Facility:** Instituto Horizonti

**State:** MG

**Location 5:**

**City:** Campo Grande

**Country:** Brazil

**Facility:** Hospital do Coração de Mato Grosso do Sul

**State:** MS

**Location 6:**

**City:** Curitiba

**Country:** Brazil

**Facility:** Santa Casa de Curitiba

**State:** PR

**Location 7:**

**City:** Londrina

**Country:** Brazil

**Facility:** Hospital Universitário de Londrina

**State:** PR

**Location 8:**

**City:** Ponta Grossa

**Country:** Brazil

**Facility:** Hospital universitário de Ponta Grossa

**State:** PR

**Location 9:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital moinhos de Vento

**State:** Rio Grande Do Sul

**Location 10:**

**City:** Porto Velho

**Country:** Brazil

**Facility:** Cemetron

**State:** RO

**Location 11:**

**City:** Canoas

**Country:** Brazil

**Facility:** Hospital Universitário de Canoas

**State:** RS

**Location 12:**

**City:** Guaíba

**Country:** Brazil

**Facility:** Hospital Nelson Cornetet

**State:** RS

**Location 13:**

**City:** Passo Fundo

**Country:** Brazil

**Facility:** Hospital das Clínicas de Passo Fundo

**State:** RS

**Location 14:**

**City:** Passo Fundo

**Country:** Brazil

**Facility:** Hospital São Vicente de Paulo

**State:** RS

**Location 15:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Fundação Universitária Instituto de Cardiologia

**State:** RS

**Location 16:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital de Clínicas de Porto Alegre

**State:** RS

**Location 17:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital Ernesto Dornelles

**State:** RS

**Location 18:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital Vila Nova

**State:** RS

**Location 19:**

**City:** Itapetininga

**Country:** Brazil

**Facility:** Hospital Leo Orsi

**State:** SP

**Location 20:**

**City:** Ribeirão Preto

**Country:** Brazil

**Facility:** Hospital Beneficência Portuguesa de Ribeirão Preto

**State:** SP

**Location 21:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital Alemão Oswaldo Cruz

**State:** SP

**Location 22:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital Beneficência Portuguesa de São Paulo

**State:** SP

**Location 23:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital do Coração

**State:** SP

**Location 24:**

**City:** São Paulo

**Country:** Brazil

**Facility:** Hospital SEPACO

**State:** SP

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital Moinhos de Vento

**Name:** Regis G Rosa, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Misc Info Module

- Version Holder: 2024-05-24
