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

NCT05587868 | Unknown DMC

• 1 other identifier: 21-10-1101
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; SARS CoV-2 Infection

Keywords

Long COVID; Post COVID-19 Syndrome; Post-Acute Sequelae of SARS-CoV2 Infection (PASC); Chronic COVID-19; Post-Acute COVID-19; Long-haulers; COVID-19 Vaccine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Change in functional exercise capacity, objectively measured using Six-Minute Walking Test (6MWT)

  Baseline, 3 and 6 months

• Change in symptoms severity

  Baseline, 3 and 6 months

• Change in symptoms frequency

  Baseline, 3 and 6 months

Study Arms (4)

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

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

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

Interventions

COVID-19 Vaccine BIOLOGICAL

Mandatory COVID-19 vaccination as part of the the Indonesian national government program.

Patients who had received first dose of vaccination for COVID-19; Patients who had received second dose vaccination for COVID-19; Patients who had received third dose/booster vaccination for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients aged ≥ 18 years
• 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
• Patients with/without comorbidities
• Willing to fill-out online Long COVID symptoms follow-up questionnaire
• Willing and able to comply with trial protocol (re-visits and physical testing)

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

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Related Links

• WHO Coronavirus (COVID-19) - Dashboard
• Long COVID: the NHS plan for 2021/22

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Eric D Tenda, MD, DIC, PhD

  Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andry Setiadharma, MD

CONTACT

+6285714519367; andrysetiadharma@gmail.com

Ni N Indira

CONTACT

+6281390705913

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Staff in Respirology and Critical Illness Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 20, 2022
• Study Start: March 11, 2022
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

ID (1)