Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population
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ClinicalTrials.gov Identifier: NCT05060562 |
Recruitment Status :
Recruiting
First Posted : September 29, 2021
Last Update Posted : July 20, 2022
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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:
- There is an association between duration of COVID episode, repeated COVID episode, and the presence of persistent COVID 19 Symptoms
- Vaccinated individual who was infected with Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV2) will have less persistent COVID 19 symptoms
- Individuals with comorbidities are prone to persistent COVID 19 Symptoms
- Appropriate medications (including early administration of antiviral therapy) lead to a lower probability of persistent COVID 19 Symptoms
Condition or disease | Intervention/treatment |
---|---|
Covid19 | Other: COVID 19 positive Other: COVID 19 negative |

Study Type : | Observational |
Estimated Enrollment : | 1152 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Predictors of the Occurrence of Post Coronavirus Disease Syndrome Among COVID-19 Patients in Indonesia |
Actual Study Start Date : | September 1, 2021 |
Estimated Primary Completion Date : | December 1, 2022 |
Estimated Study Completion Date : | February 15, 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Post COVID 19 symptoms Positive
The presence of persistent COVID-related symptoms after being cured.
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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
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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. |
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
- Asymptomatic or mild cases who underwent home isolation with telemedicine
- Patient admitted to the field hospital for close monitoring (including asymptomatic or mild cases with comorbidities)
- Patient admitted to the general hospital that requires oxygen supplementation, plasma convalescent therapy, or intensive care.
Source of data including :
- Daily observation record
- Laboratory information
- Medical Resume given to the patient
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05060562
Contact: Bumi Herman, M.D.Ph.D | 0638275008 | bumiherman@med.unhas.ac.id | |
Contact: Pramon Viwattanakulvanid, Ph.D | pramon.v@chula.ac.th |
Indonesia | |
Khairun University Faculty of Medicine | Recruiting |
Ternate, North Maluku, Indonesia | |
Contact: Aryandhito W Nugroho, Ph.D | |
Contact: Nur Upik EN Masrika, MD, M.Biomed | |
Sub-Investigator: Aryandhito W Nugroho, PhD | |
Sub-Investigator: Nur Upik EN Masrika, MD, M.Biomed | |
Hasanuddin University Medical Research Center / HUMRC | Recruiting |
Makasar, South Sulawesi, Indonesia, 90245 | |
Contact: Bumi Herman, M.D, Ph.D bumiherman@med.unhas.ac.id | |
Principal Investigator: Bumi Herman, M.D Ph.D | |
Principal Investigator: Firman Hasan, M.D | |
Principal Investigator: Karina Patricia, M.D | |
Principal Investigator: Muthiah Abustani, M.D | |
Principal Investigator: Allen Aditya, M.D |
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:
Responsible Party: | Bumi Herman, Assistant Lecturer, Hasanuddin University |
ClinicalTrials.gov Identifier: | NCT05060562 |
Other Study ID Numbers: |
1407212101 |
First Posted: | September 29, 2021 Key Record Dates |
Last Update Posted: | July 20, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | de-identified data will be shared accordingly |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID 19 Post COVID 19 symptoms |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |