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 : December 2, 2021

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Sponsor:

Collaborator:

Chulalongkorn University

Information provided by (Responsible Party):

Bumi Herman, Hasanuddin University

Study Description

Brief Summary:

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

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Detailed Description:

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

Study Design

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Study Type :	Observational
Estimated Enrollment :	1152 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
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 :	January 1, 2022
Estimated Study Completion Date :	February 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Groups and Cohorts

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.

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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Contact: Bumi Herman, M.D.Ph.D	0638275008	bumiherman@med.unhas.ac.id
Contact: Pramon Viwattanakulvanid, Ph.D		pramon.v@chula.ac.th

Locations

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Indonesia
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

Sponsors and Collaborators

Hasanuddin University

Chulalongkorn University

Investigators

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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

More Information

Additional Information:

Questionnaire in Indonesian language This link exits the ClinicalTrials.gov site

Publications:

Carfì A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.

Ahmed H, Patel K, Greenwood DC, Halpin S, Lewthwaite P, Salawu A, Eyre L, Breen A, O'Connor R, Jones A, Sivan M. Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J Rehabil Med. 2020 May 31;52(5):jrm00063. doi: 10.2340/16501977-2694.

Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9.

Lam MH, Wing YK, Yu MW, Leung CM, Ma RC, Kong AP, So WY, Fong SY, Lam SP. Mental morbidities and chronic fatigue in severe acute respiratory syndrome survivors: long-term follow-up. Arch Intern Med. 2009 Dec 14;169(22):2142-7. doi: 10.1001/archinternmed.2009.384.

Lee SH, Shin HS, Park HY, Kim JL, Lee JJ, Lee H, Won SD, Han W. Depression as a Mediator of Chronic Fatigue and Post-Traumatic Stress Symptoms in Middle East Respiratory Syndrome Survivors. Psychiatry Investig. 2019 Jan;16(1):59-64. doi: 10.30773/pi.2018.10.22.3. Epub 2019 Jan 7.

Moldofsky H, Patcai J. Chronic widespread musculoskeletal pain, fatigue, depression and disordered sleep in chronic post-SARS syndrome; a case-controlled study. BMC Neurol. 2011 Mar 24;11:37. doi: 10.1186/1471-2377-11-37.

Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026.

Shah W, Hillman T, Playford ED, Hishmeh L. Managing the long term effects of covid-19: summary of NICE, SIGN, and RCGP rapid guideline. BMJ. 2021 Jan 22;372:n136. doi: 10.1136/bmj.n136.

Moreno-Pérez O, Merino E, Leon-Ramirez JM, Andres M, Ramos JM, Arenas-Jiménez J, Asensio S, Sanchez R, Ruiz-Torregrosa P, Galan I, Scholz A, Amo A, González-delaAleja P, Boix V, Gil J; COVID19-ALC research group. Post-acute COVID-19 syndrome. Incidence and risk factors: A Mediterranean cohort study. J Infect. 2021 Mar;82(3):378-383. doi: 10.1016/j.jinf.2021.01.004. Epub 2021 Jan 12.

Jacobs LG, Gourna Paleoudis E, Lesky-Di Bari D, Nyirenda T, Friedman T, Gupta A, Rasouli L, Zetkulic M, Balani B, Ogedegbe C, Bawa H, Berrol L, Qureshi N, Aschner JL. Persistence of symptoms and quality of life at 35 days after hospitalization for COVID-19 infection. PLoS One. 2020 Dec 11;15(12):e0243882. doi: 10.1371/journal.pone.0243882. eCollection 2020.

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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:	December 2, 2021
Last Verified:	November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	de-identified data will be shared accordingly

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Bumi Herman, Hasanuddin University:


COVID 19 Post COVID 19 symptoms

Additional relevant MeSH terms:

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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

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