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Post Coronavirus Disease (COVID-19) Syndrome Indonesian Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05060562
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : December 2, 2021
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Bumi Herman, Hasanuddin University

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. 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

Condition or disease Intervention/treatment
Covid19 Other: COVID 19 positive Other: COVID 19 negative

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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


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 :
  1. 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



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

  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
Criteria

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

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
Additional Information:
Publications:

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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