COVID-19NCT05242185
Long Term Sequelae of COVID-19: Follow-up Study in Dhaka, Bangladesh
An observational study of COVID-19, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
COVID-19 or coronavirus disease 2019 is an emerging infectious disease. The disease was first identified in China and then spread worldwide; hence, declared as a global pandemic on March 11, 2020 by World Health Organization (WHO). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Observational study
- How many people
- 398 participants
- Where
- 1 siteBangladesh
- Study dates
- 8 Feb 2021to 4 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will include all patients who have SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR) following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU
Who may be able to join
- Age ≥ 18 years
- Participants categorized as mild, moderate and severe/critical disease according to the classification of WHO and the national guideline on COVID-19 case management published by the DGHS [28], Bangladesh and discharged from the hospital or outpatient clinic
- Participants residing within Dhaka city corporation area
- Willing to participate in this study
- Same as exposed group except that they are not exposed to SARS-CoV-2 infection as evident by negative RT-PCR test. Other criteria for comparison group are given below.
- Participants will be included if the RT-PCR test is negative during enrollment
Show all 9Show fewer
- Age ≥ 18 years
- Participants residing within Dhaka city corporation area
- Willing to participate in this study
Who cannot join
- Participants will be excluded if they have a history mental illness before COVID-19
- Participants with RT-PCR-confirmed SARS-CoV-2 infections but without any relevant clinical symptoms in the preceding fourteen days will be excluded.
- Participants residing outside the Dhaka city corporation area and not willing to participate in the study
- Participants with any known co morbidities including obesity will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Sequelae of COVID-19: a Longitudinal Follow-up Study in Dhaka, Bangladesh
COVID-19 or coronavirus disease 2019 is an emerging infectious disease. The disease was first identified in China and then spread worldwide; hence, declared as a global pandemic on March 11, 2020 by World Health Organization (WHO). The pandemic is posing formidable challenges to healthcare systems and humanities worldwide resulting in morbidities and mortalities unthought of. Rapidly accumulating clinical evidence on COVID-19 paved the way for an extensive and prompt characterization of the acute phase of the disease. The clinical presentation is generally that of a respiratory infection with a symptom severity ranging from a mild common cold-like illness, to a severe viral pneumonia leading to acute respiratory distress syndrome that is potentially fatal. Characteristic symptoms include fever, cough, and dyspnoea, although some patients may be asymptomatic. Complications of severe disease include, but are not limited to, multi-organ failure, septic shock, and acute respiratory distress syndrome. The COVID-19 infection fatality rate is between 0.5 and 1 percent and the remaining affected patients will mostly recover but need convalescent care. However, discharge should not be considered as the final point of overcoming coronavirus and till date evidence on sequelae of the COVID-19 recovered patients is very limited. COVID-19 is a complex multisystem disease that affects pulmonary function, as well as renal, cardiovascular, and neuropsychiatric health, metabolic derangement; and nutritional status. The extent to which these alterations may persist remains obscure, till date evidence on long term sequelae of the COVID-19 recovered patients is very limited. Some of the aftereffects of it may have a profound impact on 'recovered' patients in the future.
Long-term morbidities were observed in survivors of severe acute respiratory syndrome but it is unidentified whether experience from SARS is applicable to COVID-19. The SARS-CoV-2 infection is severe in older, immune deficient people and who have any pre-existing medical conditions. Hence, it is imperative to comprehend the possible long-term sequelae of the COVID-19 recovered patients, and if they will develop any other harmful illnesses. This study would help us to understand the in-depth prognosis and sequelae of the disease, as well as help to uncover to what extent would COVID-19 recovered patients require post-acute care to recuperate from any further infections or multi-organ damage.
Read the detailed description
Coronavirus disease 2019 (COVID-19) is caused by a novel coronavirus, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). From December 2019, it has rapidly spread across China and many other countries. COVID-19 pandemic is posing formidable challenges to healthcare systems and humanities worldwide resulting in morbidities and mortalities unthought of.
The first case of COVID-19 was officially detected in Bangladesh on March 8, 2020. As of December 10, 2020, according to the Institute of Epidemiology, Disease Control and Research (IEDCR), there are 485,965confirmed COVID-19 cases in Bangladesh with 6,967 related deaths and the Case Fatality Rate (CFR) is 1.38%. The overall attack rate is 1,639 per 1 million.
Regarding age distribution, 27% of cases were between 31 and 40 years old, 21% in the age group of 21 and 30 years, 19% were between 41 and 50 years, and 15% were in the age group of 51 and 60 years Regarding geographical distribution, 64% of reported confirmed cases were from the Dhaka district, followed by 5.7%in Chattagram district. Case doubling time is 5 days for both the Dhaka and Chattagram district.
COVID-19 is a complex multisystem disease that affects pulmonary function, as well as renal, cardiovascular, and neuropsychiatric health, coagulation derangement as well as nutritional status A significant proportion of patients who survive from COVID-19 may have the possibility to get impairment in their overall health status after their recovery. The extent to which these alterations may persist remains obscure. Some of the aftereffects of it may have a profound impact on 'recovered' patients in the future This study would help us to understand the in-depth prognosis and sequelae of the disease, as well as help to uncover to what extent would COVID-19 recovered patients require post-acute care to recuperate from any further infections or multi-organ damage.
This is a prospective cohort study which will be done in Dhaka hospital of icddr,b and BSMMU. We will include all patients aged ≥ 18 years who have COVID-19, confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR), following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU. Baseline data of prognostic importance, including demographic, social information, lifestyle factors, medical history, underlying comorbidities, anthropometric measurements, clinical, laboratory, imaging and treatment records will be collected using a standard case report form. A detailed clinical examination including measurement of vital signs, blood pressure, pulse oximetry, anthropometric measurements, neurological, pulmonary, cardiovascular system examination will be performed by trained research physicians at enrollment and at each follow-up visit. We will perform routine laboratory assays including complete blood count (CBC), serum alanine transaminase (ALT), serum creatinine, fasting capillary blood glucose using glucometer and urine routine examination. We will also perform ECG, echocardiography, chest X-ray and pulmonary function test. Additional tests will be done as and when required such as RT-PCR test in nasopharyngeal specimen, as well as fasting blood sugar, glycated haemoglobin, MRI/CT scan of brain etc. Thyroid function tests such as FT4, FT3 and TSH and C peptide will be performed at 5 month follow-up time point along with other routine investigations. Participants will be followed up at at 3,5,9,12 ,18 ,24-month time points following discharge from hospital or OPD, and at any time they have a complain.
- Conditions
- COVID-19
- Being tested
- Observational study
- Keywords
- COVID-19, long term sequelae
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Also called Follow- up
- Baseline data of prognostic importance, including demographic, social information, lifestyle factors, medical history, underlying comorbidities, anthropometric measurements, clinical, laboratory, imaging and treatment records will be collected using a standard case report form. A detailed clinical examination including measurement of vital signs, blood pressure, pulse oximetry, anthropometric measurements, neurological, pulmonary, cardiovascular system examination, mental and fuctional status assessment. routine laboratory assays including complete blood count (CBC), serum alanine transaminase (ALT), serum creatinine, fasting capillary blood glucose using glucometer and urine routine examination, ECG, echocardiography, chest X-ray and pulmonary function test. Additional tests when required such as fasting blood sugar, glycated haemoglobin, MRI/CT scan of brain, Thyroid function tests such as FT4, FT3 and TSH and C peptide etc
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 survivors | All patients age 18years and more who have SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR) following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point will be the prevalence and incidence of long term sequelae of COVID-19
- Incidence and prevalence of long-term sequelae
- Persistence or development of symptoms at different time-points of follow-up in mild, moderate or severe disease symptoms like
- dyspnea,
- fatigue,
- cough,
- fever,
- thoracic pain,
- nausea,
- diarrhea,
- headache
Measured: 24 months
Secondary outcomes (1)
Prevalence and incidence of long term (after 6 weeks) sequelae among OPD and hospitalized group COVID-19
- Incidence of long term (after 6 weeks) sequelae among survivors of COVID-19
- Incidence of abnormal mental health evident by having PTSD as diagnosed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) or having a MMSE score of ≤24 (out of 30) or neurological sequelae
- Abnormal pulmonary function: Presence of dyspnea as evident by ≥1 score in modified Medical Research Council (mMRC) scale or reduced six-minute walk distance (<580 m men and <500 m for women) or abnormal pulmonary function test.
- Cardiovascular sequelae: echocardiographic evidence of pulmonary hypertension and left ventricular dysfunction
- New onset diabetes or worsening glycemic control
- Incidence of undernutrition, overweight or obesity
- Association between demographic, social, lifestyle factors, medical history, underlying comorbidities and persistence of COVID-19 related symptoms and sequelae
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start8 Feb 2021
- Primary completion4 Apr 2022 (estimated)
- Study completion4 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242185
- Sponsor's protocol ID
- PR-20128
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Sequelae of COVID-19: a Longitudinal Follow-up Study in Dhaka, Bangladesh
- ClinicalTrials.gov ID
- NCT05242185
- Acronym / sponsor ID
- PR-20128
- Conditions
- COVID-19
- Keywords
- COVID-19, long term sequelae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 4 Apr 2022 (estimated)
- Study completion
- 4 Apr 2022 (estimated)
- First posted
- 16 Feb 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.
COVID-19 or coronavirus disease 2019 is an emerging infectious disease. The disease was first identified in China and then spread worldwide; hence, declared as a global pandemic on March 11, 2020 by World Health Organization (WHO). The pandemic is posing formidable challenges to healthcare systems and humanities worldwide resulting in morbidities and mortalities unthought of. Rapidly accumulating clinical evidence on COVID-19 paved the way for an extensive and prompt characterization of the acute phase of the disease. The clinical presentation is generally that of a respiratory infection with a symptom severity ranging from a mild common cold-like illness, to a severe viral pneumonia leading to acute respiratory distress syndrome that is potentially fatal. Characteristic symptoms include fever, cough, and dyspnoea, although some patients may be asymptomatic. Complications of severe disease include, but are not limited to, multi-organ failure, septic shock, and acute respiratory distress syndrome. The COVID-19 infection fatality rate is between 0.5 and 1 percent and the remaining affected patients will mostly recover but need convalescent care. However, discharge should not be considered as the final point of overcoming coronavirus and till date evidence on sequelae of the COVID-19 recovered patients is very limited. COVID-19 is a complex multisystem disease that affects pulmonary function, as well as renal, cardiovascular, and neuropsychiatric health, metabolic derangement; and nutritional status. The extent to which these alterations may persist remains obscure, till date evidence on long term sequelae of the COVID-19 recovered patients is very limited. Some of the aftereffects of it may have a profound impact on 'recovered' patients in the future.
Long-term morbidities were observed in survivors of severe acute respiratory syndrome but it is unidentified whether experience from SARS is applicable to COVID-19. The SARS-CoV-2 infection is severe in older, immune deficient people and who have any pre-existing medical conditions. Hence, it is imperative to comprehend the possible long-term sequelae of the COVID-19 recovered patients, and if they will develop any other harmful illnesses. This study would help us to understand the in-depth prognosis and sequelae of the disease, as well as help to uncover to what extent would COVID-19 recovered patients require post-acute care to recuperate from any further infections or multi-organ damage.
Detailed description
Coronavirus disease 2019 (COVID-19) is caused by a novel coronavirus, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). From December 2019, it has rapidly spread across China and many other countries. COVID-19 pandemic is posing formidable challenges to healthcare systems and humanities worldwide resulting in morbidities and mortalities unthought of.
The first case of COVID-19 was officially detected in Bangladesh on March 8, 2020. As of December 10, 2020, according to the Institute of Epidemiology, Disease Control and Research (IEDCR), there are 485,965confirmed COVID-19 cases in Bangladesh with 6,967 related deaths and the Case Fatality Rate (CFR) is 1.38%. The overall attack rate is 1,639 per 1 million.
Regarding age distribution, 27% of cases were between 31 and 40 years old, 21% in the age group of 21 and 30 years, 19% were between 41 and 50 years, and 15% were in the age group of 51 and 60 years Regarding geographical distribution, 64% of reported confirmed cases were from the Dhaka district, followed by 5.7%in Chattagram district. Case doubling time is 5 days for both the Dhaka and Chattagram district.
COVID-19 is a complex multisystem disease that affects pulmonary function, as well as renal, cardiovascular, and neuropsychiatric health, coagulation derangement as well as nutritional status A significant proportion of patients who survive from COVID-19 may have the possibility to get impairment in their overall health status after their recovery. The extent to which these alterations may persist remains obscure. Some of the aftereffects of it may have a profound impact on 'recovered' patients in the future This study would help us to understand the in-depth prognosis and sequelae of the disease, as well as help to uncover to what extent would COVID-19 recovered patients require post-acute care to recuperate from any further infections or multi-organ damage.
This is a prospective cohort study which will be done in Dhaka hospital of icddr,b and BSMMU. We will include all patients aged ≥ 18 years who have COVID-19, confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR), following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU. Baseline data of prognostic importance, including demographic, social information, lifestyle factors, medical history, underlying comorbidities, anthropometric measurements, clinical, laboratory, imaging and treatment records will be collected using a standard case report form. A detailed clinical examination including measurement of vital signs, blood pressure, pulse oximetry, anthropometric measurements, neurological, pulmonary, cardiovascular system examination will be performed by trained research physicians at enrollment and at each follow-up visit. We will perform routine laboratory assays including complete blood count (CBC), serum alanine transaminase (ALT), serum creatinine, fasting capillary blood glucose using glucometer and urine routine examination. We will also perform ECG, echocardiography, chest X-ray and pulmonary function test. Additional tests will be done as and when required such as RT-PCR test in nasopharyngeal specimen, as well as fasting blood sugar, glycated haemoglobin, MRI/CT scan of brain etc. Thyroid function tests such as FT4, FT3 and TSH and C peptide will be performed at 5 month follow-up time point along with other routine investigations. Participants will be followed up at at 3,5,9,12 ,18 ,24-month time points following discharge from hospital or OPD, and at any time they have a complain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 survivors | – | Other: Observational studyAll patients age 18years and more who have SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR) following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will include all patients who have SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR) following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Participants categorized as mild, moderate and severe/critical disease according to the classification of WHO and the national guideline on COVID-19 case management published by the DGHS [28], Bangladesh and discharged from the hospital or outpatient clinic
- Participants residing within Dhaka city corporation area
- Willing to participate in this study
- Same as exposed group except that they are not exposed to SARS-CoV-2 infection as evident by negative RT-PCR test. Other criteria for comparison group are given below.
Key exclusion criteria (4 listed)
- Participants will be excluded if they have a history mental illness before COVID-19
- Participants with RT-PCR-confirmed SARS-CoV-2 infections but without any relevant clinical symptoms in the preceding fourteen days will be excluded.
- Participants residing outside the Dhaka city corporation area and not willing to participate in the study
- Participants with any known co morbidities including obesity will be excluded
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 |
|---|---|---|
| Observational studyAlso: Follow- up- Baseline data of prognostic importance, including demographic, social information, lifestyle factors, medical history, underlying comorbidities, anthropometric measurements, clinical, laboratory, imaging and treatment records will be collected using a standard case report form. A detailed clinical examination including measurement of vital signs, blood pressure, pulse oximetry, anthropometric measurements, neurological, pulmonary, cardiovascular system examination, mental and fuctional status assessment. routine laboratory assays including complete blood count (CBC), serum alanine transaminase (ALT), serum creatinine, fasting capillary blood glucose using glucometer and urine routine examination, ECG, echocardiography, chest X-ray and pulmonary function test. Additional tests when required such as fasting blood sugar, glycated haemoglobin, MRI/CT scan of brain, Thyroid function tests such as FT4, FT3 and TSH and C peptide etc | Other | COVID-19 survivors |
Primary outcome
The primary end point will be the prevalence and incidence of long term sequelae of COVID-19
Time frame: 24 months
1. Incidence and prevalence of long-term sequelae 2. Persistence or development of symptoms at different time-points of follow-up in mild, moderate or severe disease symptoms like * dyspnea, * fatigue, * cough, * fever, * thoracic pain, * nausea, * diarrhea, * headache
1 secondary outcome
Prevalence and incidence of long term (after 6 weeks) sequelae among OPD and hospitalized group COVID-19
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 9 inclusion and 4 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 11 Apr 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 Bangladesh. 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?
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?
The primary end point will be the prevalence and incidence of long term sequelae of COVID-19 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.