Post-acute COVID-19 SyndromeNCT05185674
Sociodemographic, Clinical, Quality of Life and Health Care Conditions in COVID-19 Survivors.
An observational study of Post-acute COVID-19 Syndrome and Long-COVID, run by Javier Eslava at 1 site in Colombia.
Trial summary
Sociodemographic, Clinical, Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to the Intensive Care Unit for COVID-19 at the Hospital Universitario Nacional Between April 2020 and March 2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-acute COVID-19 Syndrome, Long-COVID, COVID-19
- What is being tested?
- Exposure: Coronavirus disease 2019 (COVID-19)
- How many people
- 114 participants
- Where
- 1 siteColombia
- Study dates
- 10 Sep 2021to 15 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: : Patients admitted to the Intensive Care Unit of the Hospital Universitario Nacional de Colombia (Bogotá, Colombia) between April 1, 2020 and March 31, 2021.
Who may be able to join
- Living patients, who presented COVID-19 with admission to the Intensive Care Unit of the National University Hospital of Colombia between April 1, 2020 and March 31, 2021.
- Patients 18 years of age and older
- COVID-19 confirmed by polymerase chain reaction (PCR) test positive for SARS-CoV-19.
- Signature of informed consent
Who cannot join
- Missing data in the database, referring to the variables of interest
- Pregnant patients
- Limitation for communication in Spanish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sociodemographic,Clinical,Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to ICU for COVID-19 at Hospital Universitario Nacional Between April 2020 and March 2021. Bogotá, Colombia
Sociodemographic, Clinical, Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to the Intensive Care Unit for COVID-19 at the Hospital Universitario Nacional Between April 2020 and March 2021. Bogotá, Colombia
The main objective of this study is to characterize the sociodemographic, clinical, quality of life and health care conditions in a cohort of patients who have survived a stay in the Intensive Care Unit of the National University Hospital of Colombia. Secondarily, associations between these findings and sociodemographic and clinical characteristics will be evaluated.
It is expected to contribute to the scientific literature through the characterization and epidemiology of the problem in a sample of patients from a Latin American country. It is planned to contribute not only with clinical data, but also with data on socioeconomic impacts on patients and notions of the health care they are receiving. Through the analyzes to be carried out, associations that will contribute to the evidence for prevention and management of the outcome will be explored.
Read the detailed description
Progressively, the evidence is growing that COVID-19 survivors present persistent or new symptoms and / or alterations in diagnostic studies / functional tests. There is no consensual characterization and denomination for this outcome, proposing names such as "Long-COVID" or "Post-COVID Syndrome", among others. Nor are there homogeneous estimates regarding incidence and prevalence. Most of the population studies and surveys have been conducted in the United States, China, and European countries. It is considered that this problem can have negative effects on the quality of life, the health of patients and a significant burden of disease for the system. Patients may face inequities and barriers in health care.
At the national and global level; it is projected that large numbers of people may present or are exhibiting this "syndrome." Knowing the situation is necessary to formulate and develop responses in terms of prevention, diagnosis, management and rehabilitation.
This study will be carried out with the main purpose of characterizing the sociodemographic, clinical, quality of life and health care conditions in a cohort of patients who have survived a stay in the Intensive Care Unit of the National University Hospital of Colombia. Secondarily, associations between these findings and sociodemographic and clinical characteristics will be evaluated.
The study will be developed with patients who have been admitted to the Intensive Care Unit of the National University Hospital of Colombia for COVID-19. Once the study is explained to the potential participants, doubts are resolved and informed consent is obtained; clinical variables registered in the database will be taken and a remote interview (virtual, telephone) will be carried out with the participant applying the collection instrument that contains questions of own elaboration and validated and recognized scales. No physical, treatment or experimentation interventions will be made. The study period is from April 1, 2020 to March 31, 2021. A pilot test is included to determine the applicability of the collection instrument, average duration of the interview, feasibility of filling out informed consent by electronic means and disposition of the participants to receive the information and be part of the study.
The data is recorded in REDCap and will be taken to the R-Studio statistical program, through which and with the STATA v16.1 program the analysis will be executed.
As a benefit to patients, a copy of their answers to the instrument's medical questions and a medical guidance will be sent to them. It will be explained to the participants that said orientation does not replace a formal medical consultation nor does it correspond to a teleconsultation and medical orders will not be issued.
This study also corresponds to a Master's thesis in Public Health for the Universidad Nacional de Colombia, within the framework of the "Equidad en Salud" Research Group of the Universidad Nacional de Colombia.
- Conditions
- Post-acute COVID-19 Syndrome, Long-COVID, COVID-19, Long COVID, Post-acute Sequelae of SARS-CoV-2 Infection
- Being tested
- Exposure: Coronavirus disease 2019 (COVID-19)
- Keywords
- Sequelae, Quality of Life, Delivery of Health Care, Socioeconomic factors, Mental health, Functional status, Intensive Care Unit, COVID-19, Post-acute COVID-19 syndrome, Long-COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: Coronavirus disease 2019 (COVID-19)Other
Having presented Coronavirus disease 2019 (COVID-19) and stay in the Intensive Care Unit
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 survivors subjects | All patients discharged from the National University Hospital of Colombia (Bogotá, Colombia) who required admission to the Intensive Care Unit of the same institution with a confirmed diagnosis of SARS-CoV-2 disease (COVID-19 disease) between April 1, 2020 and March 31, 2021
* Severe Acute Respiratory Syndrome (SARS)
* Coronavirus (CoV) Receives: Other: Exposure: Coronavirus disease 2019 (COVID-19) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with new or persistent symptoms after COVID-19 Number of participants with new or persistent symptoms after COVID-19
Percentage of Participants with one or more new or persistent symptoms. Assessment of the presence or absence of one or more new or persistent symptoms after having COVID-19, reported as yes or no for each symptom.
If the participant manifests dyspnea, the severity will be evaluated using the Modified Medical Research Council (mMRC) instrument, with scoring options from 0 to 4. The higher score the worse the symptoms.
Measured: Baseline (At the time of the interview and application of the collection instrument)
Health-related quality of life before and after presenting COVID-19
The instrument 12-Item Short-Form Health Survey (SF-12v2) version in Spanish for Colombia will be applied. The valid questionnaire consists of 12 questions about mental and physical health. Questions will be asked for the current moment and also directed to before having COVID-19. Scores ranging from 0 to 100 with higher score indicating better health.
Measured: Baseline (At the time of the interview and application of the collection instrument)
Health care conditions after presenting COVID-19
The participants will be asked questions designed by the researchers in the collection instrument about medical controls that they have received after medical discharge from COVID-19 and mainly for new or persistent symptoms, reported as yes or no medical control. Frequency of each barrier in access to health services (by default in the collection instrument elaborated by researchers).
Measured: Baseline (At the time of the interview and application of the collection instrument)
Socioeconomic impact after presenting COVID-19
Frequency of each economic impact like salary decrease or job loss. The participants will be asked questions designed by the researchers in the collection instrument about possible personal socioeconomic impacts of having fallen ill with COVID-19 and being admitted to the Intensive Care Unit.
Measured: Baseline (At the time of the interview and application of the collection instrument)
Mental health symptoms before and after presenting COVID-19
The researchers use the valid instrument Self-Reporting Questionnaire (SRQ-20) version in Spanish. The scale consists of 20 questions to be answered: yes or no. The score ranges from 0-20, each positive answer add 1 point. Higher score indicating greater possibility of psychological distress.
Measured: Baseline (At the time of the interview and application of the collection instrument)
Functional Independence before and after presenting COVID-19
The Barthel Index, Spanish version, will be applied to assessment functional independence. Scores ranges from 0 to 100, when 100 is better outcome (independence) and 0 is worst outcome (total dependence).
Measured: Baseline (At the time of the interview and application of the collection instrument)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Sep 2021
- Primary completion29 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Eslava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier Eslava, Universidad Nacional de Colombia
- Investigators
- Laura C Loaiza-Fernandez, MD,MSc (c), Principal investigator, Universidad Nacional de ColombiaJairo A Pérez-Cely, MD, ICU, Principal investigator, Hospital Universitario Nacional de Colombia / Universidad Nacional de ColombiaJavier H Eslava-Schamalbach, MD, PhD, Principal investigator, Universidad Nacional de Colombia / Hospital Universitario Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185674
- Sponsor's protocol ID
- 53543 (Hermes)
- Other IDs
- CEI-2021-06-01
- Status last verified
- Sep 2022
- First submitted
- 7 Jan 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are protected by legislation and by ethical standards for research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociodemographic,Clinical,Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to ICU for COVID-19 at Hospital Universitario Nacional Between April 2020 and March 2021. Bogotá, Colombia
- ClinicalTrials.gov ID
- NCT05185674
- Acronym / sponsor ID
- 53543 (Hermes)
- Conditions
- Post-acute COVID-19 Syndrome, Long-COVID, COVID-19, Long COVID, Post-acute Sequelae of SARS-CoV-2 Infection
- Keywords
- Sequelae, Quality of Life, Delivery of Health Care, Socioeconomic factors, Mental health, Functional status, Intensive Care Unit, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Javier EslavaUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sociodemographic, Clinical, Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to the Intensive Care Unit for COVID-19 at the Hospital Universitario Nacional Between April 2020 and March 2021. Bogotá, Colombia
The main objective of this study is to characterize the sociodemographic, clinical, quality of life and health care conditions in a cohort of patients who have survived a stay in the Intensive Care Unit of the National University Hospital of Colombia. Secondarily, associations between these findings and sociodemographic and clinical characteristics will be evaluated.
It is expected to contribute to the scientific literature through the characterization and epidemiology of the problem in a sample of patients from a Latin American country. It is planned to contribute not only with clinical data, but also with data on socioeconomic impacts on patients and notions of the health care they are receiving. Through the analyzes to be carried out, associations that will contribute to the evidence for prevention and management of the outcome will be explored.
Detailed description
Progressively, the evidence is growing that COVID-19 survivors present persistent or new symptoms and / or alterations in diagnostic studies / functional tests. There is no consensual characterization and denomination for this outcome, proposing names such as "Long-COVID" or "Post-COVID Syndrome", among others. Nor are there homogeneous estimates regarding incidence and prevalence. Most of the population studies and surveys have been conducted in the United States, China, and European countries. It is considered that this problem can have negative effects on the quality of life, the health of patients and a significant burden of disease for the system. Patients may face inequities and barriers in health care.
At the national and global level; it is projected that large numbers of people may present or are exhibiting this "syndrome." Knowing the situation is necessary to formulate and develop responses in terms of prevention, diagnosis, management and rehabilitation.
This study will be carried out with the main purpose of characterizing the sociodemographic, clinical, quality of life and health care conditions in a cohort of patients who have survived a stay in the Intensive Care Unit of the National University Hospital of Colombia. Secondarily, associations between these findings and sociodemographic and clinical characteristics will be evaluated.
The study will be developed with patients who have been admitted to the Intensive Care Unit of the National University Hospital of Colombia for COVID-19. Once the study is explained to the potential participants, doubts are resolved and informed consent is obtained; clinical variables registered in the database will be taken and a remote interview (virtual, telephone) will be carried out with the participant applying the collection instrument that contains questions of own elaboration and validated and recognized scales. No physical, treatment or experimentation interventions will be made. The study period is from April 1, 2020 to March 31, 2021. A pilot test is included to determine the applicability of the collection instrument, average duration of the interview, feasibility of filling out informed consent by electronic means and disposition of the participants to receive the information and be part of the study.
The data is recorded in REDCap and will be taken to the R-Studio statistical program, through which and with the STATA v16.1 program the analysis will be executed.
As a benefit to patients, a copy of their answers to the instrument's medical questions and a medical guidance will be sent to them. It will be explained to the participants that said orientation does not replace a formal medical consultation nor does it correspond to a teleconsultation and medical orders will not be issued.
This study also corresponds to a Master's thesis in Public Health for the Universidad Nacional de Colombia, within the framework of the "Equidad en Salud" Research Group of the Universidad Nacional de Colombia.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 survivors subjects | – | Other: Exposure: Coronavirus disease 2019 (COVID-19)All patients discharged from the National University Hospital of Colombia (Bogotá, Colombia) who required admission to the Intensive Care Unit of the same institution with a confirmed diagnosis of SARS-CoV-2 disease (COVID-19 disease) between April 1, 2020 and March 31, 2021 * Severe Acute Respiratory Syndrome (SARS) * Coronavirus (CoV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- : Patients admitted to the Intensive Care Unit of the Hospital Universitario Nacional de Colombia (Bogotá, Colombia) between April 1, 2020 and March 31, 2021.
Key inclusion criteria (4 listed)
- Living patients, who presented COVID-19 with admission to the Intensive Care Unit of the National University Hospital of Colombia between April 1, 2020 and March 31, 2021.
- Patients 18 years of age and older
- COVID-19 confirmed by polymerase chain reaction (PCR) test positive for SARS-CoV-19.
- Signature of informed consent
Key exclusion criteria (3 listed)
- Missing data in the database, referring to the variables of interest
- Pregnant patients
- Limitation for communication in Spanish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: Coronavirus disease 2019 (COVID-19)Having presented Coronavirus disease 2019 (COVID-19) and stay in the Intensive Care Unit | Other | COVID-19 survivors subjects |
Primary outcome
Number of participants with new or persistent symptoms after COVID-19 Number of participants with new or persistent symptoms after COVID-19
Time frame: Baseline (At the time of the interview and application of the collection instrument)
Percentage of Participants with one or more new or persistent symptoms. Assessment of the presence or absence of one or more new or persistent symptoms after having COVID-19, reported as yes or no for each symptom. If the participant manifests dyspnea, the severity will be evaluated using the Modified Medical Research Council (mMRC) instrument, with scoring options from 0 to 4. The higher score the worse the symptoms.
Health-related quality of life before and after presenting COVID-19
Time frame: Baseline (At the time of the interview and application of the collection instrument)
The instrument 12-Item Short-Form Health Survey (SF-12v2) version in Spanish for Colombia will be applied. The valid questionnaire consists of 12 questions about mental and physical health. Questions will be asked for the current moment and also directed to before having COVID-19. Scores ranging from 0 to 100 with higher score indicating better health.
Health care conditions after presenting COVID-19
Time frame: Baseline (At the time of the interview and application of the collection instrument)
The participants will be asked questions designed by the researchers in the collection instrument about medical controls that they have received after medical discharge from COVID-19 and mainly for new or persistent symptoms, reported as yes or no medical control. Frequency of each barrier in access to health services (by default in the collection instrument elaborated by researchers).
Socioeconomic impact after presenting COVID-19
Time frame: Baseline (At the time of the interview and application of the collection instrument)
Frequency of each economic impact like salary decrease or job loss. The participants will be asked questions designed by the researchers in the collection instrument about possible personal socioeconomic impacts of having fallen ill with COVID-19 and being admitted to the Intensive Care Unit.
Mental health symptoms before and after presenting COVID-19
Time frame: Baseline (At the time of the interview and application of the collection instrument)
The researchers use the valid instrument Self-Reporting Questionnaire (SRQ-20) version in Spanish. The scale consists of 20 questions to be answered: yes or no. The score ranges from 0-20, each positive answer add 1 point. Higher score indicating greater possibility of psychological distress.
Functional Independence before and after presenting COVID-19
Time frame: Baseline (At the time of the interview and application of the collection instrument)
The Barthel Index, Spanish version, will be applied to assessment functional independence. Scores ranges from 0 to 100, when 100 is better outcome (independence) and 0 is worst outcome (total dependence).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No. Individual participant data are protected by legislation and by ethical standards for research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura C Loaiza-Fernandez, MD,MSc (c) principal investigator
Universidad Nacional de Colombia
Jairo A Pérez-Cely, MD, ICU principal investigator
Hospital Universitario Nacional de Colombia / Universidad Nacional de Colombia
Javier H Eslava-Schamalbach, MD, PhD principal investigator
Universidad Nacional de Colombia / Hospital Universitario Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-acute COVID-19 Syndrome and Long-COVID, run by Javier Eslava at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with new or persistent symptoms after COVID-19 Number of participants with new or persistent symptoms after COVID-19 (time frame: Baseline (At the time of the interview and application of the collection instrument)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.