COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients (SURVIVOR)

October 26, 2022 updated by: Eric Daniel Tenda MD, DIC, PhD, Indonesia University

Karakteristik Dan Pengaruh Vaksinasi COVID-19 Terhadap Klinis Dan Kualitas Hidup Pasien Long COVID di RSUPN Dr. Cipto Mangunkusumo

Long COVID is defined by the persistence or emergence of symptoms for more than 4 weeks beyond the acute phase of Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) infection. As the number of cases increases and various strains of SARS-CoV-2 emerge, so does the number of long COVID cases. Various multi-organ complications after COVID-19 infection include respiratory, cardiovascular, gastrointestinal, hepatobiliary, metabolic, and neuropsychiatric disorders. The symptoms and characteristics of Long COVID vary in each country.

Vaccination against SARS-CoV-2 has been documented to increase clinical resolution of Long COVID. In Indonesia, current full-dose vaccination coverage had merely reached 15.6% of the national vaccination target. This condition can be predictably associated with a longer duration and higher severity of symptoms in Long COVID patients.

The purpose of this study is to provide an overview of the symptoms and characteristics and determine whether vaccination against SARS-CoV-2 could improve clinical outcomes and quality of life of Long COVID patients at Dr. Cipto Mangunkusumo General Hospital.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective cohort study designed to assess whether vaccination against SARS-CoV-2 could reduce the severity and duration of Long COVID, resulting in changes in quality of life in Long-COVID patients. This study was approved by the Institutional Review Board of Universitas Indonesia and informed consent was obtained before enrollment for patients eligible for this study. Allocation of participants to each group was done via vaccination status data collected before enrollment in this study.

Baseline participant characteristics were collected before enrollment, including age, sex, body mass index, alcohol and smoking consumption, comorbidities, documented vaccination status, detailed history of laboratory-confirmed SARS-CoV-2 infection, Long COVID symptoms, severity, and duration. The Six-Minute Walking Test (6MWT) was performed according to the guidelines of the American Thoracic Society (ATS) to assess functional exercise capacity in each patient, followed by a quality of life assessment using the St George's Respiratory Questionnaire (SGRQ) and the Short Form (SF)-36 Health Survey questionnaire.

The primary outcomes of this study were long-COVID patients' characteristics, symptom phenotype, and changes in quality of life. The investigators anticipated a change in quality of life difference of 20%, with statistical power of 80% and a level of significance of 0.05. The total required sample size was 192 participants. In anticipation of participant drop-out, the investigators planned to recruit a total of 250 participants.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ni N Indira
  • Phone Number: +6281390705913

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Long COVID-19 patients received outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital during the COVID-19 infection anytime before enrollment in this study.

Description

Inclusion Criteria:

  1. Adult patients aged ≥ 18 years
  2. History of laboratory-confirmed SARS-CoV-2 infection via a positive molecular (RT-PCR) or antigen (lateral flow assay) test, receiving outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital, anytime prior to enrollment in this study
  3. Patients with/without comorbidities
  4. Willing to fill-out online Long COVID symptoms follow-up questionnaire
  5. Willing and able to comply with trial protocol (re-visits and physical testing)

Exclusion Criteria:

  1. Patients with no registered medical record number (MRN) at Dr. Cipto Mangunkusumo General Hospital
  2. Refusal to participate in the study or to sign the informed consent form
  3. Any contraindications for 6 Minute Walking Test according to the guidelines of the American Thoracic Society (ATS)
  4. Patients with no access to a smartphone or computer (desktop, laptop, or tablet) to fill out the online screening questionnaire
  5. Patients who died during or before enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who have not received vaccination for COVID-19
This group includes patients who refused or contraindicated to receive vaccination for COVID-19.
Patients who had received first dose of vaccination for COVID-19
Regardless of the type of COVID-19 vaccine used (received before or after laboratory-confirmed SARS-CoV-2 infection).
Biological: COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
Patients who had received second dose vaccination for COVID-19
Regardless of the type of COVID-19 vaccine used, using same type of vaccine as the first dose (received before and/or after laboratory-confirmed SARS-CoV-2 infection).
Biological: COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
Patients who had received third dose/booster vaccination for COVID-19
Complete cycle of vaccination using same type of vaccine for the first and second dose and a same/different type for the third dose/booster (received before and/or after laboratory-confirmed SARS-CoV-2 infection).
Biological: COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long COVID symptoms phenotype
Time Frame: Up to 6 months

Wide range of symptoms associated with Long COVID in which people have persistent or emerging symptoms > 4 weeks after an initial SARS-CoV-2 infection.

In this study symptoms will be reported and analyzed by both symptom clusters and individual symptoms.
Up to 6 months
Change in quality of life (QoL), self-assessed using the St George's Respiratory Questionnaire (SGRQ)
Time Frame: Baseline, 3 and 6 months
SGRQ addresses QoL in the domains of symptoms, activity, impacts within last 4 weeks. Symptoms, activity, impacts and total score are calculated to summarises the impacts of the disease on overall health status. Total score ranges from 100 (worst possible health status) to 0 (best possible health status).
Baseline, 3 and 6 months
Change in quality of life (QoL), self-assessed using the Short Form (SF)-36 Health Survey questionnaire
Time Frame: Baseline, 3 and 6 months
SF-36 Health Survey questionnaire addresses QoL in the domains of vitality, physical functioning, bodily pain, general health perceptions, physical and emotional and social role functioning. The final score ranges from 0 (worse health status) to 100 (better health status).
Baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional exercise capacity, objectively measured using Six-Minute Walking Test (6MWT)
Time Frame: Baseline, 3 and 6 months

Performed according to the guidelines of American Thoracic Society (ATS)

6MWT evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.

During the 6MWT, such data are collected:

  • Pre-post test: blood pressure, oxygen saturation (SpO2), heart rate, dyspnea and overall fatigue score using the Modified Borg scale
  • One time measurement: total distance walked in 6 minutes, symptoms at the end of exercise
Baseline, 3 and 6 months
Change in symptoms severity
Time Frame: Baseline, 3 and 6 months

Subjectively measured using online self-assessed symptoms follow-up questionnaire, disease severity is measured using ordinal scale, with 11 steps ranging from 0 (no symptoms) to 10 (Very severe).

The change in symptom severity will be described by whether participants report that symptoms have become more severe, less severe, or did not change severity.
Baseline, 3 and 6 months
Change in symptoms frequency
Time Frame: Baseline, 3 and 6 months

Subjectively measured using online self-assessed symptoms follow-up questionnaire, symptom frequency is measured using ordinal scale, with 11 steps ranging from 0 (no symptoms) to 10 (All time).

The study outcome will be reported by both symptom clusters and individual symptoms. The change in symptom frequency will be described by whether participants report that symptoms have become more frequent, less frequent, or did not change.
Baseline, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Eric D Tenda, MD, DIC, PhD, Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-10-1101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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