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

COVID-19 Clinical Trial

— SURVIVOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587868
• Other study ID #: 21-10-1101
• Status: Recruiting
• Start date: March 11, 2022
• Est. completion date: May 2023

Study information

• Verified date: October 2022
• Source: Indonesia University
• Contact: Andry Setiadharma, MD
• Phone: +6285714519367
• Email: andrysetiadharma[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS CoV-2 Infection

Intervention

Biological:
• COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.

Locations

Country	Name	City	State
Indonesia	Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long COVID symptoms phenotype	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
Primary	Change in quality of life (QoL), self-assessed using the St George's Respiratory Questionnaire (SGRQ)	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
Primary	Change in quality of life (QoL), self-assessed using the Short Form (SF)-36 Health Survey questionnaire	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	Change in functional exercise capacity, objectively measured using Six-Minute Walking Test (6MWT)	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
Secondary	Change in symptoms severity	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
Secondary	Change in symptoms frequency	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

External Links

•   Long COVID: the NHS plan for 2021/22
•   Satuan Tugas Penanganan COVID-19 - Data Sebaran Indonesia
•   WHO Coronavirus (COVID-19) - Dashboard