Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus

Clinical, Radiological, Lung Function, and Quality of Life Characterization of Patients With Severe/Critical Infection by SARS-COV-2 (COVID-19) Virus, After 6 and 12 Months of Hospital Discharge

A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.

Study Overview

• Status: Enrolling by invitation
• Conditions: Covid19
• Intervention / Treatment: Radiation: chest radiography; Radiation: thoracic computed tomography scan; Diagnostic test: spirometry; Diagnostic test: Diffusing capacity of carbon monoxide; Diagnostic test: 6 minute walk test; Diagnostic test: saint george respiratory questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 112

Contacts and Locations

Study Locations

• Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760001
      • Fundacion Valle del Lili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a severe or critical disease caused by SARS-COV-2 infection who were treated at the ICU of Fundación Valle del Lili and were alive at 6 months of hospital discharge.

Description

Inclusion Criteria:

• ≥ 19 years old who had a positive test for SARS-COV-2 virus
• Patients with a severe and critical disease by SARS-COV-2, who were treated at the ICU of Fundación Valle del Lili, and survived
• Patients with chest radiography or CT scan at admission to the hospital

Exclusion Criteria:

• Patients who do not sign informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Severe and critical COVID-19 survivors; Radiological alterations assessed by chest radiography and/or thoracic computed tomography Lung function alterations assessed by spirometry, diffusing capacity for carbon monoxide, 6 minute walk. Quality of life alterations: saint george respiratory questionnaire

Radiation: chest radiography; 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.; Radiation: thoracic computed tomography scan; 6 and 12 months after hospital discharge, if the patient had a CT scan upon admission to the hospital. If the study is normal at 6 months it will not be repeated at 12 months.; Diagnostic test: spirometry; 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.; Diagnostic test: Diffusing capacity of carbon monoxide; 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.; Diagnostic test: 6 minute walk test; 6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.; Diagnostic test: saint george respiratory questionnaire; 6 and 12 months after hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function	Spirometry in Liters	6 months after hospital discharge
Lung function	Spirometry in Liters	12 months after hospital discharge
Lung function	Diffusing capacity of carbon monoxide (% predicted)	6 months after hospital discharge
Lung function	Diffusing capacity of carbon monoxide (% predicted)	12 months after hospital discharge
Lung function	6 min walk test in Meters	6 months after hospital discharge
Lung function	6 min walk test in Meters	12 months after hospital discharge
Radiological alterations	Alterations in chest radiography	6 months after hospital discharge
Radiological alterations	Alterations in chest radiography	12 months after hospital discharge
Radiological alterations	Alterations in thoracic CT scan	6 months after hospital discharge
Radiological alterations	Alterations in thoracic CT scan	12 months after hospital discharge
Quality of life alterations	Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)	6 months after hospital discharge
Quality of life alterations	Saint George Respiratory questionnaire (from 0 to 100 points, higher levels indicating a major health impairment)	12 months after hospital discharge

Collaborators and Investigators

• Sponsor: Fundacion Clinica Valle del Lili
• Investigators: Principal Investigator: Fernandez, Fundacion Clinica Valle del Lili

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: lung function; quality of life; covid19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: 1631 COVID-LFT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No