Skip to main content
OpenTrials
Completed

NCT Number: NCT05060562

Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population

Background and Objective Persistent symptoms after COVID 19 episodes (or referred to as Long COVID) can appear at a certain period and affect the quality of life of the patients, as well as introduce other comorbidities. It is important to address the associated factors of persistent symptoms after the COVID 19 episode. By identifying these factors, a screening method could be deployed to detect individuals that are prone to persistent COVID 19 symptoms.

Method:

This cohort study recruit COVID 19 patients at all stages in Indonesia (including people who underwent home isolation). Patient-based clinical information is collected from the patient including the demographic information, general health status, COVID 19 vaccination, and COVID 19 treatment. The outcome is the occurrence of persistent COVID 19-related symptoms after being declared as cured. A logistic regression model and Cox Regression are applied to the model to find the associated factors. Machine learning and Deep Learning model will be constructed and deployed into a web-based application for a further screening program.

Hypothesis:

1. There is an association between duration of COVID episode, repeated COVID episode, and the presence of persistent COVID 19 Symptoms 2. Vaccinated individual who was infected with Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV2) will have less persistent COVID 19 symptoms 3. Individuals with comorbidities are prone to persistent COVID 19 Symptoms 4. Appropriate medications (including early administration of antiviral therapy) lead to a lower probability of persistent COVID 19 Symptoms

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Khairun University Faculty of Medicine, Ternate, North Maluku, Indonesia

Loading trial locations.

About this study

Target Population:

As explained in the study population section

Recruitment

  • Snowball technique from the COVID 19 survivor groups
  • Online questionnaire is provided to obtain the data

Data Source:

  • Medical Resume
  • Laboratory Information possessed by individuals
  • Telemedicine observation possessed by individuals

Predictors:

  • Demographic factors (age at diagnosis and current age at data collection, sex at birth, occupation, education, province of domicile, and possession of health insurance during COVID 19 infection)
  • General health status (Body Mass Index, presence of chronic disease and comorbidities, smoking, alcohol drinking, moderate physical activity)
  • History of COVID 19 vaccination (date, type of vaccine, booster dose, side effect, and medication following the vaccination)
  • COVID 19 episode (date of diagnosis, method of diagnosis confirmation, history of suspected SARS COV2 reinfection, Cycle-Threshold (CT) value, the symptoms and duration of the symptoms, medication, oxygen supplementation, hospitalization, or receiving plasma convalescent therapy)

List of persistent COVID 19 symptoms in this study (and not limited to)

  • Neurological and Psychiatric symptoms
  • Anxiety
  • Depression
  • Sleep disturbances
  • PTSD
  • Cognitive impairment
  • Ear Nose Throat symptoms
  • Persistent anosmia
  • Persistent ageusia
  • Tinnitus and other hearing disorders
  • Respiratory Symptoms
  • Chronic cough
  • Shortness of breath
  • Cardiovascular symptoms
  • Peripheral artery disease
  • New onset of arrhythmia
  • Carditis (either pericarditis or myocarditis)
  • Hematological symptoms
  • Thromboembolic event
  • Renal Disorder
  • Reduced filtration function
  • Musculoskeletal disorder
  • Chronic fatigue
  • Joint pain
  • Muscular pain
  • Dermatology disorder
  • Rash
  • Hair loss
  • Gastrointestinal disorder
  • Chronic Diarrhea
  • Irritable Bowel Syndrome

Study Size

  • The one-sample proportion formula
  • Type I error value as 5%.
  • The prevalence of COVID 19 in Indonesia is 1%
  • Absolute value of margin of error set as 0.5%
  • the total sample needed is 1152 participants.

Proposed Statistical Analysis

  • Data cleaning was conducted
  • No imputation to missing data
  • Descriptive statistics and normality tests
  • Logistic regression to analyze the associated factors of each outcome followed by estimating the adjusted odds ratio.
  • The time-to-event analysis for post COVID symptoms was conducted in a certain subgroup of the variables using the cox regression model.
  • Neural Network model and deployment into a web-based application

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years old
  • Diagnosed as Coronavirus Disease 2019 by RT- PCR, or Rapid Antigen

Exclusion criteria

  • Unable to retrieve information regarding the persistent symptoms
  • Died within six months after declared as cured

Treatment and study plan

COVID 19 positive

Other

Diagnosed as COVID 19 patient using Real-Time Polymerase Chain Reaction (RT-PCR) with the nasopharyngeal swab, or Rapid Antigen test of nasopharyngeal swab with suggestive symptoms.

COVID 19 negative

Other

Suspected COVID 19 patients who were tested negative using either Real-Time Polymerase Chain Reaction (RT-PCR) with the nasopharyngeal swab, or Rapid Antigen test of nasopharyngeal swab.

Primary outcomes

  1. Presence of post COVID 19 Symptoms two weeks

    Time frame: within two weeks after declared cured

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

  2. Presence of post COVID 19 Symptoms four weeks

    Time frame: within four weeks after declared cured

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

  3. Presence of post COVID 19 Symptoms eight weeks

    Time frame: within eight weeks after declared cured

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

  4. Presence of post COVID 19 Symptoms twelve weeks

    Time frame: within twelve weeks after declared cured

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

  5. Presence of post COVID 19 Symptoms six months

    Time frame: within six months after declared cured

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

Secondary outcomes

  1. Presence of post COVID 19 Symptoms among vaccinated individual diagnosed with COVID 19

    Time frame: within six months after declared cured

    Any COVID-related symptoms persist after declared cured among vaccinated individual. Defined as a binary response, yes or no

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Collaborators

  • Chulalongkorn University

Registry information

Official study title

Predictors of the Occurrence of Post Coronavirus Disease Syndrome Among COVID-19 Patients in Indonesia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2021
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.