Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05060562
• Other study ID #: 1407212101
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2023
• Source: Hasanuddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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: 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6051
• Est. completion date: November 15, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Hasanuddin University Medical Research Center / HUMRC	Makasar	South Sulawesi
Indonesia	Khairun University Faculty of Medicine	Ternate	North Maluku

Sponsors (2)

Lead Sponsor	Collaborator
Hasanuddin University	Chulalongkorn University

Country where clinical trial is conducted

Indonesia, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: BMJ. 2022 Jan 19;376:o126. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of post COVID 19 Symptoms two weeks	Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no	within two weeks after declared cured
Primary	Presence of post COVID 19 Symptoms four weeks	Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no	within four weeks after declared cured
Primary	Presence of post COVID 19 Symptoms eight weeks	Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no	within eight weeks after declared cured
Primary	Presence of post COVID 19 Symptoms twelve weeks	Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no	within twelve weeks after declared cured
Primary	Presence of post COVID 19 Symptoms six months	Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no	within six months after declared cured
Secondary	Presence of post COVID 19 Symptoms among vaccinated individual diagnosed with COVID 19	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

External Links

•   Questionnaire in Indonesian language