Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population
NCT ID: NCT05060562
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
6051 participants
OBSERVATIONAL
2021-09-01
2023-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Post COVID 19 symptoms Positive
The presence of persistent COVID-related symptoms after being cured.
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.
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
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosed as Coronavirus Disease 2019 by RT- PCR, or Rapid Antigen
Exclusion Criteria
2. Died within six months after declared as cured
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chulalongkorn University
OTHER
Hasanuddin University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bumi Herman
Assistant Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bumi Herman, M.D Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Sathirakorn Pongpanich, Ph.D
Role: STUDY_DIRECTOR
Chulalongkorn University
Pramon Viwattanakulvanid, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Khairun University Faculty of Medicine
Ternate, North Maluku, Indonesia
Hasanuddin University Medical Research Center / HUMRC
Makassar, South Sulawesi, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Carfi 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. doi: 10.1136/thx.2004.030205.
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. No abstract available.
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. No abstract available.
Moreno-Perez O, Merino E, Leon-Ramirez JM, Andres M, Ramos JM, Arenas-Jimenez J, Asensio S, Sanchez R, Ruiz-Torregrosa P, Galan I, Scholz A, Amo A, Gonzalez-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.
Herman B, Wong MCS, Chantharit P, Hannanu FF, Viwattanakulvanid P. Longitudinal study of disease severity and external factors in cognitive failure after COVID-19 among Indonesian population. Sci Rep. 2023 Nov 8;13(1):19405. doi: 10.1038/s41598-023-46334-2.
Herman B, Bruni A, Zain E, Dzulhadj A, Oo AC; Viwattanakulvanid. Post-COVID depression and its multiple factors, does Favipiravir have a protective effect? A longitudinal study of indonesia COVID-19 patients. PLoS One. 2022 Dec 30;17(12):e0279184. doi: 10.1371/journal.pone.0279184. eCollection 2022.
Related Links
Access external resources that provide additional context or updates about the study.
Questionnaire in Indonesian language
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1407212101
Identifier Type: -
Identifier Source: org_study_id