Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population

NCT05060562 | Completed DMC

• 1 other identifier: 1407212101
• Study Type: observational
• Target: 6,051
• Locations: 1 country
• Sites: 2

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:

1. 1.There is an association between duration of COVID episode, repeated COVID episode, and the presence of persistent COVID 19 Symptoms
2. 2.Vaccinated individual who was infected with Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV2) will have less persistent COVID 19 symptoms
3. 3.Individuals with comorbidities are prone to persistent COVID 19 Symptoms
4. 4.Appropriate medications (including early administration of antiviral therapy) lead to a lower probability of persistent COVID 19 Symptoms

Conditions

Covid19

Keywords

COVID 19; Post COVID 19 symptoms

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Presence of post COVID 19 Symptoms among vaccinated individual diagnosed with COVID 19

  within six months after declared cured

Study Arms (2)

Post COVID 19 symptoms Positive

The presence of persistent COVID-related symptoms after being cured.

Other: COVID 19 positive; Other: COVID 19 negative

Post COVID 19 symptoms Negative

No persistent COVID-related symptoms after cured

Other: COVID 19 positive; Other: COVID 19 negative

Interventions

COVID 19 positive OTHER

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.

Post COVID 19 symptoms Negative; Post COVID 19 symptoms Positive

COVID 19 negative OTHER

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; Post COVID 19 symptoms Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hasanuddin University: lead
• Chulalongkorn University: collaborator

Study Sites (2)

Khairun University Faculty of Medicine

Ternate, North Maluku, Indonesia

Location

Hasanuddin University Medical Research Center / HUMRC

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (13)

• 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.

  PMID: 32644129 BACKGROUND

• 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.

  PMID: 33428867 BACKGROUND

• 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.

  PMID: 32449782 BACKGROUND

• 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.

  PMID: 15860716 BACKGROUND

• 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.

  PMID: 20008700 BACKGROUND

• 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.

  PMID: 30605995 BACKGROUND

• 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.

  PMID: 21435231 BACKGROUND

• 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.

  PMID: 32784198 BACKGROUND

• 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.

  PMID: 33483331 BACKGROUND

• 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.

  PMID: 33450302 BACKGROUND

• 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.

  PMID: 33306721 BACKGROUND

• 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.

  PMID: 37938599 DERIVED

• 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.

  PMID: 36584099 DERIVED

Related Links

• Questionnaire in Indonesian language

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bumi Herman, M.D Ph.D

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Sathirakorn Pongpanich, Ph.D

  Chulalongkorn University

  STUDY DIRECTOR

• Pramon Viwattanakulvanid, Ph.D

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: November 15, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

ID (2)