COVID-19 Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
| Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
| Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
| Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
| Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
| Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
| Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
| Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
| Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
| Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
| Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
| Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
| Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
| Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
| Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|