Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population

November 24, 2023 updated by: Bumi Herman, Hasanuddin University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Target Population:

As explained in the study population section

Recruitment

  1. Snowball technique from the COVID 19 survivor groups
  2. Online questionnaire is provided to obtain the data

Data Source:

  1. Medical Resume
  2. Laboratory Information possessed by individuals
  3. Telemedicine observation possessed by individuals

Predictors:

  1. 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)
  2. General health status (Body Mass Index, presence of chronic disease and comorbidities, smoking, alcohol drinking, moderate physical activity)
  3. History of COVID 19 vaccination (date, type of vaccine, booster dose, side effect, and medication following the vaccination)
  4. 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)

  1. Neurological and Psychiatric symptoms

    • Anxiety
    • Depression
    • Sleep disturbances
    • PTSD
    • Cognitive impairment

  2. Ear Nose Throat symptoms

    • Persistent anosmia
    • Persistent ageusia
    • Tinnitus and other hearing disorders

  3. Respiratory Symptoms

    • Chronic cough
    • Shortness of breath

  4. Cardiovascular symptoms

    • Peripheral artery disease
    • New onset of arrhythmia
    • Carditis (either pericarditis or myocarditis)

  5. Hematological symptoms

    • Thromboembolic event

  6. Renal Disorder

    • Reduced filtration function

  7. Musculoskeletal disorder

    • Chronic fatigue
    • Joint pain
    • Muscular pain

  8. Dermatology disorder

    • Rash
    • Hair loss

  9. Gastrointestinal disorder

    • Chronic Diarrhea
    • Irritable Bowel Syndrome

Study Size

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

Proposed Statistical Analysis

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

Study Type

Observational

Enrollment (Actual)

6051

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

Study Locations

  • Indonesia
    • North Maluku
      • Ternate, North Maluku, Indonesia
        • Khairun University Faculty of Medicine
    • South Sulawesi
      • Makasar, South Sulawesi, Indonesia, 90245
        • Hasanuddin University Medical Research Center / HUMRC

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any stage of Coronavirus Disease 2019 patients during the pandemic in Indonesia that are able to provide their clinical information and daily observation with the details as follows

  1. Asymptomatic or mild cases who underwent home isolation with telemedicine
  2. Patient admitted to the field hospital for close monitoring (including asymptomatic or mild cases with comorbidities)
  3. Patient admitted to the general hospital that requires oxygen supplementation, plasma convalescent therapy, or intensive care.

Source of data including :

  1. Daily observation record
  2. Laboratory information
  3. Medical Resume given to the patient

Description

Inclusion criteria

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

Exclusion Criteria

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post COVID 19 symptoms Positive
The presence of persistent COVID-related symptoms after being cured.
Other: COVID 19 positive
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.
Other: COVID 19 negative
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.
Post COVID 19 symptoms Negative
No persistent COVID-related symptoms after cured
Other: COVID 19 positive
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.
Other: COVID 19 negative
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within two weeks after declared cured
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
within four weeks after declared cured
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
within eight weeks after declared cured
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
within twelve weeks after declared cured
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
within six months after declared cured

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within six months after declared cured

Collaborators and Investigators

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

Sponsor

Hasanuddin University

Collaborators

Chulalongkorn University

Investigators

  • Principal Investigator: Bumi Herman, M.D Ph.D, Chulalongkorn University
  • Study Director: Sathirakorn Pongpanich, Ph.D, Chulalongkorn University
  • Principal Investigator: Pramon Viwattanakulvanid, Ph.D, Chulalongkorn University

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)

September 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1407212101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

de-identified data will be shared accordingly

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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