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Covid19NCT05060562

Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population

An observational study of Covid19, run by Hasanuddin University at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
COVID 19 positive and COVID 19 negative
How many people
6,051 participants
Where
2 sitesIndonesia
Study dates
1 Sep 2021to 15 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Hasanuddin University Medical Research Center / HUMRC

    Makassar, South Sulawesi, 90245

  • Khairun University Faculty of Medicine

    Ternate, North Maluku

Other trials in Indonesia

About this study

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

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:

Read more

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
Read the detailed 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
  1. Ear Nose Throat symptoms
  • Persistent anosmia
  • Persistent ageusia
  • Tinnitus and other hearing disorders
  1. Respiratory Symptoms
  • Chronic cough
  • Shortness of breath
  1. Cardiovascular symptoms
  • Peripheral artery disease
  • New onset of arrhythmia
  • Carditis (either pericarditis or myocarditis)
  1. Hematological symptoms
  • Thromboembolic event
  1. Renal Disorder
  • Reduced filtration function
  1. Musculoskeletal disorder
  • Chronic fatigue
  • Joint pain
  • Muscular pain
  1. Dermatology disorder
  • Rash
  • Hair loss
  1. 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
Covid19
Being tested
COVID 19 positive, COVID 19 negative
Keywords
COVID 19, Post COVID 19 symptoms
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID 19 positiveOther

    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 negativeOther

    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.

Study groups in NCT05060562
Study groupRoleWhat they receive
Post COVID 19 symptoms PositiveThe presence of persistent COVID-related symptoms after being cured.
Receives: Other: COVID 19 positive; Other: COVID 19 negative
Post COVID 19 symptoms NegativeNo persistent COVID-related symptoms after cured
Receives: Other: COVID 19 positive; Other: COVID 19 negative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of post COVID 19 Symptoms two weeks

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

    Measured: within two weeks after declared cured

  2. Presence of post COVID 19 Symptoms four weeks

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

    Measured: within four weeks after declared cured

  3. Presence of post COVID 19 Symptoms eight weeks

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

    Measured: within eight weeks after declared cured

  4. Presence of post COVID 19 Symptoms twelve weeks

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

    Measured: within twelve weeks after declared cured

  5. Presence of post COVID 19 Symptoms six months

    Any COVID-related symptoms persist after declared cured. Defined as a binary response, yes or no

    Measured: within six months after declared cured

Secondary outcomes (1)

  1. 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

    Measured: within six months after declared cured

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Sep 2023
  4. Study completion15 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,051 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060562
Sponsor's protocol ID
1407212101
Status last verified
Nov 2023
First submitted
20 Sep 2021
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: de-identified data will be shared accordingly

Publications

  • 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.

    PubMed 32644129

  • 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.

    PubMed 33428867

  • 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.

    PubMed 32449782

  • 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.

    PubMed 15860716

  • 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.

    PubMed 20008700

  • 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.

    PubMed 30605995

  • 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.

    PubMed 21435231

  • 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.

    PubMed 32784198

  • 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.

    PubMed 33483331

  • 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.

    PubMed 33450302

  • 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.

    PubMed 33306721

  • 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.

    PubMed 37938599

  • 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.

    PubMed 36584099

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Hasanuddin University at 2 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of post COVID 19 Symptoms two weeks (time frame: within two weeks after declared cured). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05060562, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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