COVID-19SURVIVORNCT05587868
COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients
An observational study of COVID-19 and SARS CoV-2 Infection, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Long COVID is defined by the persistence or emergence of symptoms for more than 4 weeks beyond the acute phase of Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) infection. As the number of cases increases and various strains of SARS-CoV-2 emerge, so does the number of long COVID cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS CoV-2 Infection
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 250 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Mar 2022to May 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: Long COVID-19 patients received outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital during the COVID-19 infection anytime before enrollment in this study.
Who may be able to join
- Adult patients aged ≥ 18 years
- History of laboratory-confirmed SARS-CoV-2 infection via a positive molecular (RT-PCR) or antigen (lateral flow assay) test, receiving outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital, anytime prior to enrollment in this study
- Patients with/without comorbidities
- Willing to fill-out online Long COVID symptoms follow-up questionnaire
- Willing and able to comply with trial protocol (re-visits and physical testing)
Who cannot join
- Patients with no registered medical record number (MRN) at Dr. Cipto Mangunkusumo General Hospital
- Refusal to participate in the study or to sign the informed consent form
- Any contraindications for 6 Minute Walking Test according to the guidelines of the American Thoracic Society (ATS)
- Patients with no access to a smartphone or computer (desktop, laptop, or tablet) to fill out the online screening questionnaire
- Patients who died during or before enrollment in the study
Trial locations and contacts
1 site in 1 country.
Ni N Indira contact
Indonesia1 site, 1 recruiting
- Recruiting
Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Karakteristik Dan Pengaruh Vaksinasi COVID-19 Terhadap Klinis Dan Kualitas Hidup Pasien Long COVID di RSUPN Dr. Cipto Mangunkusumo
Long COVID is defined by the persistence or emergence of symptoms for more than 4 weeks beyond the acute phase of Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) infection. As the number of cases increases and various strains of SARS-CoV-2 emerge, so does the number of long COVID cases. Various multi-organ complications after COVID-19 infection include respiratory, cardiovascular, gastrointestinal, hepatobiliary, metabolic, and neuropsychiatric disorders. The symptoms and characteristics of Long COVID vary in each country.
Vaccination against SARS-CoV-2 has been documented to increase clinical resolution of Long COVID. In Indonesia, current full-dose vaccination coverage had merely reached 15.6% of the national vaccination target. This condition can be predictably associated with a longer duration and higher severity of symptoms in Long COVID patients.
The purpose of this study is to provide an overview of the symptoms and characteristics and determine whether vaccination against SARS-CoV-2 could improve clinical outcomes and quality of life of Long COVID patients at Dr. Cipto Mangunkusumo General Hospital.
Read the detailed description
The study is a prospective cohort study designed to assess whether vaccination against SARS-CoV-2 could reduce the severity and duration of Long COVID, resulting in changes in quality of life in Long-COVID patients. This study was approved by the Institutional Review Board of Universitas Indonesia and informed consent was obtained before enrollment for patients eligible for this study. Allocation of participants to each group was done via vaccination status data collected before enrollment in this study.
Baseline participant characteristics were collected before enrollment, including age, sex, body mass index, alcohol and smoking consumption, comorbidities, documented vaccination status, detailed history of laboratory-confirmed SARS-CoV-2 infection, Long COVID symptoms, severity, and duration. The Six-Minute Walking Test (6MWT) was performed according to the guidelines of the American Thoracic Society (ATS) to assess functional exercise capacity in each patient, followed by a quality of life assessment using the St George's Respiratory Questionnaire (SGRQ) and the Short Form (SF)-36 Health Survey questionnaire.
The primary outcomes of this study were long-COVID patients' characteristics, symptom phenotype, and changes in quality of life. The investigators anticipated a change in quality of life difference of 20%, with statistical power of 80% and a level of significance of 0.05. The total required sample size was 192 participants. In anticipation of participant drop-out, the investigators planned to recruit a total of 250 participants.
- Conditions
- COVID-19, SARS CoV-2 Infection
- Being tested
- COVID-19 Vaccine
- Keywords
- Long COVID, Post COVID-19 Syndrome, Post-Acute Sequelae of SARS-CoV2 Infection (PASC), Chronic COVID-19, Post-Acute COVID-19, Long-haulers, COVID-19 Vaccine
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have not received vaccination for COVID-19 | This group includes patients who refused or contraindicated to receive vaccination for COVID-19. | |
| Patients who had received first dose of vaccination for COVID-19 | Regardless of the type of COVID-19 vaccine used (received before or after laboratory-confirmed SARS-CoV-2 infection). Receives: Biological: COVID-19 Vaccine | |
| Patients who had received second dose vaccination for COVID-19 | Regardless of the type of COVID-19 vaccine used, using same type of vaccine as the first dose (received before and/or after laboratory-confirmed SARS-CoV-2 infection). Receives: Biological: COVID-19 Vaccine | |
| Patients who had received third dose/booster vaccination for COVID-19 | Complete cycle of vaccination using same type of vaccine for the first and second dose and a same/different type for the third dose/booster (received before and/or after laboratory-confirmed SARS-CoV-2 infection). Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long COVID symptoms phenotype
Wide range of symptoms associated with Long COVID in which people have persistent or emerging symptoms > 4 weeks after an initial SARS-CoV-2 infection.
In this study symptoms will be reported and analyzed by both symptom clusters and individual symptoms.
Measured: Up to 6 months
Change in quality of life (QoL), self-assessed using the St George's Respiratory Questionnaire (SGRQ)
SGRQ addresses QoL in the domains of symptoms, activity, impacts within last 4 weeks. Symptoms, activity, impacts and total score are calculated to summarises the impacts of the disease on overall health status. Total score ranges from 100 (worst possible health status) to 0 (best possible health status).
Measured: Baseline, 3 and 6 months
Change in quality of life (QoL), self-assessed using the Short Form (SF)-36 Health Survey questionnaire
SF-36 Health Survey questionnaire addresses QoL in the domains of vitality, physical functioning, bodily pain, general health perceptions, physical and emotional and social role functioning. The final score ranges from 0 (worse health status) to 100 (better health status).
Measured: Baseline, 3 and 6 months
Secondary outcomes (3)
Change in functional exercise capacity, objectively measured using Six-Minute Walking Test (6MWT)
Performed according to the guidelines of American Thoracic Society (ATS)
6MWT evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.
During the 6MWT, such data are collected:
- Pre-post test: blood pressure, oxygen saturation (SpO2), heart rate, dyspnea and overall fatigue score using the Modified Borg scale
- One time measurement: total distance walked in 6 minutes, symptoms at the end of exercise
Measured: Baseline, 3 and 6 months
Change in symptoms severity
Subjectively measured using online self-assessed symptoms follow-up questionnaire, disease severity is measured using ordinal scale, with 11 steps ranging from 0 (no symptoms) to 10 (Very severe).
The change in symptom severity will be described by whether participants report that symptoms have become more severe, less severe, or did not change severity.
Measured: Baseline, 3 and 6 months
Change in symptoms frequency
Subjectively measured using online self-assessed symptoms follow-up questionnaire, symptom frequency is measured using ordinal scale, with 11 steps ranging from 0 (no symptoms) to 10 (All time).
The study outcome will be reported by both symptom clusters and individual symptoms. The change in symptom frequency will be described by whether participants report that symptoms have become more frequent, less frequent, or did not change.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start11 Mar 2022
- Primary completionNov 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Daniel Tenda MD, DIC, PhD, Universitas Indonesia
- Investigators
- Eric D Tenda, MD, DIC, PhD, Principal investigator, Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587868
- Sponsor's protocol ID
- 21-10-1101
- Acronym
- SURVIVOR
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
PubMed 33753937Chopra V, Flanders SA, O'Malley M, Malani AN, Prescott HC. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. 2021 Apr;174(4):576-578. doi: 10.7326/M20-5661. Epub 2020 Nov 11. No abstract available.
PubMed 33175566Carfi 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 32644129Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
PubMed 33692530Arnold DT, Milne A, Samms E, Stadon L, Maskell NA, Hamilton FW. Are Vaccines Safe in Patients with Long COVID? A prospective Observational Study. medRxiv. 2021; 03.11.21253225
Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
PubMed 32087114Gupta A, Madhavan MV, Sehgal K, Nair N, Mahajan S, Sehrawat TS, Bikdeli B, Ahluwalia N, Ausiello JC, Wan EY, Freedberg DE, Kirtane AJ, Parikh SA, Maurer MS, Nordvig AS, Accili D, Bathon JM, Mohan S, Bauer KA, Leon MB, Krumholz HM, Uriel N, Mehra MR, Elkind MSV, Stone GW, Schwartz A, Ho DD, Bilezikian JP, Landry DW. Extrapulmonary manifestations of COVID-19. Nat Med. 2020 Jul;26(7):1017-1032. doi: 10.1038/s41591-020-0968-3. Epub 2020 Jul 10.
PubMed 32651579Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.
PubMed 32853602Shang J, Ye G, Shi K, Wan Y, Luo C, Aihara H, Geng Q, Auerbach A, Li F. Structural basis of receptor recognition by SARS-CoV-2. Nature. 2020 May;581(7807):221-224. doi: 10.1038/s41586-020-2179-y. Epub 2020 Mar 30.
PubMed 32225175Goertz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.
PubMed 33257910Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
PubMed 34308300Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA, Cuapio A, Villapol S. More than 50 Long-term effects of COVID-19: a systematic review and meta-analysis. medRxiv [Preprint]. 2021 Jan 30:2021.01.27.21250617. doi: 10.1101/2021.01.27.21250617.
PubMed 33532785Udwadia ZF, Koul PA, Richeldi L. Post-COVID lung fibrosis: The tsunami that will follow the earthquake. Lung India. 2021 Mar;38(Supplement):S41-S47. doi: 10.4103/lungindia.lungindia_818_20.
PubMed 33686978Wang Y, Dong C, Hu Y, Li C, Ren Q, Zhang X, Shi H, Zhou M. Temporal Changes of CT Findings in 90 Patients with COVID-19 Pneumonia: A Longitudinal Study. Radiology. 2020 Aug;296(2):E55-E64. doi: 10.1148/radiol.2020200843. Epub 2020 Mar 19.
PubMed 32191587Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun.
PubMed 32381497
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karakteristik Dan Pengaruh Vaksinasi COVID-19 Terhadap Klinis Dan Kualitas Hidup Pasien Long COVID di RSUPN Dr. Cipto Mangunkusumo
- ClinicalTrials.gov ID
- NCT05587868
- Acronym / sponsor ID
- SURVIVOR / 21-10-1101
- Conditions
- COVID-19, SARS CoV-2 Infection
- Keywords
- Long COVID, Post COVID-19 Syndrome, Post-Acute Sequelae of SARS-CoV2 Infection (PASC), Chronic COVID-19, Post-Acute COVID-19, Long-haulers, COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long COVID is defined by the persistence or emergence of symptoms for more than 4 weeks beyond the acute phase of Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) infection. As the number of cases increases and various strains of SARS-CoV-2 emerge, so does the number of long COVID cases. Various multi-organ complications after COVID-19 infection include respiratory, cardiovascular, gastrointestinal, hepatobiliary, metabolic, and neuropsychiatric disorders. The symptoms and characteristics of Long COVID vary in each country.
Vaccination against SARS-CoV-2 has been documented to increase clinical resolution of Long COVID. In Indonesia, current full-dose vaccination coverage had merely reached 15.6% of the national vaccination target. This condition can be predictably associated with a longer duration and higher severity of symptoms in Long COVID patients.
The purpose of this study is to provide an overview of the symptoms and characteristics and determine whether vaccination against SARS-CoV-2 could improve clinical outcomes and quality of life of Long COVID patients at Dr. Cipto Mangunkusumo General Hospital.
Detailed description
The study is a prospective cohort study designed to assess whether vaccination against SARS-CoV-2 could reduce the severity and duration of Long COVID, resulting in changes in quality of life in Long-COVID patients. This study was approved by the Institutional Review Board of Universitas Indonesia and informed consent was obtained before enrollment for patients eligible for this study. Allocation of participants to each group was done via vaccination status data collected before enrollment in this study.
Baseline participant characteristics were collected before enrollment, including age, sex, body mass index, alcohol and smoking consumption, comorbidities, documented vaccination status, detailed history of laboratory-confirmed SARS-CoV-2 infection, Long COVID symptoms, severity, and duration. The Six-Minute Walking Test (6MWT) was performed according to the guidelines of the American Thoracic Society (ATS) to assess functional exercise capacity in each patient, followed by a quality of life assessment using the St George's Respiratory Questionnaire (SGRQ) and the Short Form (SF)-36 Health Survey questionnaire.
The primary outcomes of this study were long-COVID patients' characteristics, symptom phenotype, and changes in quality of life. The investigators anticipated a change in quality of life difference of 20%, with statistical power of 80% and a level of significance of 0.05. The total required sample size was 192 participants. In anticipation of participant drop-out, the investigators planned to recruit a total of 250 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients who have not received vaccination for COVID-19 | – | –This group includes patients who refused or contraindicated to receive vaccination for COVID-19. |
| Patients who had received first dose of vaccination for COVID-19 | – | Biological: COVID-19 VaccineRegardless of the type of COVID-19 vaccine used (received before or after laboratory-confirmed SARS-CoV-2 infection). |
| Patients who had received second dose vaccination for COVID-19 | – | Biological: COVID-19 VaccineRegardless of the type of COVID-19 vaccine used, using same type of vaccine as the first dose (received before and/or after laboratory-confirmed SARS-CoV-2 infection). |
| Patients who had received third dose/booster vaccination for COVID-19 | – | Biological: COVID-19 VaccineComplete cycle of vaccination using same type of vaccine for the first and second dose and a same/different type for the third dose/booster (received before and/or after laboratory-confirmed SARS-CoV-2 infection). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Long COVID-19 patients received outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital during the COVID-19 infection anytime before enrollment in this study.
Key inclusion criteria (5 listed)
- Adult patients aged ≥ 18 years
- History of laboratory-confirmed SARS-CoV-2 infection via a positive molecular (RT-PCR) or antigen (lateral flow assay) test, receiving outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital, anytime prior to enrollment in this study
- Patients with/without comorbidities
- Willing to fill-out online Long COVID symptoms follow-up questionnaire
- Willing and able to comply with trial protocol (re-visits and physical testing)
Key exclusion criteria (5 listed)
- Patients with no registered medical record number (MRN) at Dr. Cipto Mangunkusumo General Hospital
- Refusal to participate in the study or to sign the informed consent form
- Any contraindications for 6 Minute Walking Test according to the guidelines of the American Thoracic Society (ATS)
- Patients with no access to a smartphone or computer (desktop, laptop, or tablet) to fill out the online screening questionnaire
- Patients who died during or before enrollment in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccineMandatory COVID-19 vaccination as part of the the Indonesian national government program. | Biological | Patients who had received first dose of vaccination for COVID-19, Patients who had received second dose vaccination for COVID-19, Patients who had received third dose/booster vaccination for COVID-19 |
Primary outcome
Long COVID symptoms phenotype
Time frame: Up to 6 months
Wide range of symptoms associated with Long COVID in which people have persistent or emerging symptoms > 4 weeks after an initial SARS-CoV-2 infection. In this study symptoms will be reported and analyzed by both symptom clusters and individual symptoms.
Change in quality of life (QoL), self-assessed using the St George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline, 3 and 6 months
SGRQ addresses QoL in the domains of symptoms, activity, impacts within last 4 weeks. Symptoms, activity, impacts and total score are calculated to summarises the impacts of the disease on overall health status. Total score ranges from 100 (worst possible health status) to 0 (best possible health status).
Change in quality of life (QoL), self-assessed using the Short Form (SF)-36 Health Survey questionnaire
Time frame: Baseline, 3 and 6 months
SF-36 Health Survey questionnaire addresses QoL in the domains of vitality, physical functioning, bodily pain, general health perceptions, physical and emotional and social role functioning. The final score ranges from 0 (worse health status) to 100 (better health status).
3 secondary outcomes
Change in functional exercise capacity, objectively measured using Six-Minute Walking Test (6MWT)
Time frame: Baseline, 3 and 6 months
Change in symptoms severity
Time frame: Baseline, 3 and 6 months
Change in symptoms frequency
Time frame: Baseline, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Background: PubMed 33753937Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
- Background: PubMed 33175566Chopra V, Flanders SA, O'Malley M, Malani AN, Prescott HC. Sixty-Day Outcomes Among Patients Hospitalized With COVID-19. Ann Intern Med. 2021 Apr;174(4):576-578. doi: 10.7326/M20-5661. Epub 2020 Nov 11. No abstract available.
- Background: PubMed 32644129Carfi 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.
- Background: PubMed 33692530Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
- BackgroundArnold DT, Milne A, Samms E, Stadon L, Maskell NA, Hamilton FW. Are Vaccines Safe in Patients with Long COVID? A prospective Observational Study. medRxiv. 2021; 03.11.21253225
- Background: PubMed 32087114Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32651579Gupta A, Madhavan MV, Sehgal K, Nair N, Mahajan S, Sehrawat TS, Bikdeli B, Ahluwalia N, Ausiello JC, Wan EY, Freedberg DE, Kirtane AJ, Parikh SA, Maurer MS, Nordvig AS, Accili D, Bathon JM, Mohan S, Bauer KA, Leon MB, Krumholz HM, Uriel N, Mehra MR, Elkind MSV, Stone GW, Schwartz A, Ho DD, Bilezikian JP, Landry DW. Extrapulmonary manifestations of COVID-19. Nat Med. 2020 Jul;26(7):1017-1032. doi: 10.1038/s41591-020-0968-3. Epub 2020 Jul 10.
- Background: PubMed 32853602Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.
- Background: PubMed 32225175Shang J, Ye G, Shi K, Wan Y, Luo C, Aihara H, Geng Q, Auerbach A, Li F. Structural basis of receptor recognition by SARS-CoV-2. Nature. 2020 May;581(7807):221-224. doi: 10.1038/s41586-020-2179-y. Epub 2020 Mar 30.
- Background: PubMed 33257910Goertz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.
- Background: PubMed 34308300Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
- Background: PubMed 33532785Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA, Cuapio A, Villapol S. More than 50 Long-term effects of COVID-19: a systematic review and meta-analysis. medRxiv [Preprint]. 2021 Jan 30:2021.01.27.21250617. doi: 10.1101/2021.01.27.21250617.
- WHO Coronavirus (COVID-19) - DashboardLink provided by the sponsor.
- Long COVID: the NHS plan for 2021/22Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Post-Acute COVID-19 Syndrome
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ni N Indira contact
Eric D Tenda, MD, DIC, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS CoV-2 Infection, run by Universitas Indonesia at 1 site 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andry Setiadharma, MD (+6285714519367, andrysetiadharma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long COVID symptoms phenotype (time frame: Up to 6 months). The study lists 3 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 NCT05587868, which also lists 25 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 28 Oct 2022.