Covid19COVID-19NCT04874792
Clinical Characteristics of Deceased With COVID-19
An observational study of Covid19, run by Dhaka Medical College at 1 site in Bangladesh.
Trial summary
This study aims to describe the clinical characteristics of patients who died from COVID-19 in the largest hospital in Bangladesh to understand the risk associated with COVID-19 related mortality in this region. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Covid19
- How many people
- 282 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2020to 31 Dec 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients died from COVID-19 in Dhaka Medical College Hospital confirmed by Real-Time reverse transcription Polymerase Chain Reaction during the period from 3rd May 2020 to 31st August 2020.
Who may be able to join
- All Patients died from COVID-19 confirmed with rt PCR for SARS-CoV-2
Who cannot join
- Suspected COVID-19 patients negative for rt PCR for SARS-CoV-2 and
- Age less than 14 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics of Deceased With COVID-19: Review of Medical Records in a Referral Hospital Dedicated for COVID-19
This study aims to describe the clinical characteristics of patients who died from COVID-19 in the largest hospital in Bangladesh to understand the risk associated with COVID-19 related mortality in this region. This is a retrospective study where a review of hospital records of patients will be done who died from COVID-19 in Dhaka Medical College Hospital from 3rd May to 31 August 2020. All available demographic, clinical, laboratory information, radiological feature, and patients' management will be retrieved from the record section to be analyzed and described.
Read the detailed description
In this retrospective observational study, every consecutive patient who died and tested positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Dhaka Medical College Hospital from 2nd May 2020 to 31 August 2020 were included. The paper files of patients were retrieved from the record section of the hospital as only a paper-based recording is maintained in the hospital. Patients with suspected COVID-19 were excluded from the study who tested negative for Reverse Transcriptase Polymerase Chain Reaction (RT PCR for SARS-CoV-2).
A preformed case record form (CRF) was used to collect all available demographic, clinical information including presentation, investigation, and treatment from hospital paper file from the record section. The severity of disease for COVID-19 was classified according to National Guidelines on Clinical Management of COVID-19 Version 8.0, 5 November 2020. The mild disease was defined as an individual with COVID-19 with prodromal symptoms without dyspnea and radiological abnormality. The moderate disease was defined as abnormal chest imaging with the saturation of oxygen ≥ 90% and severe disease was denied as saturation of oxygen less than 90%. All data were summarized, analyzed with SPPS 26.
RT PCR for SARS-CoV-2 assay is done in the virology department of Dhaka Medical College to detect SARS-Cov-2 RNA from samples taken from suspected patients. Nasopharyngeal swabs and the oropharyngeal swab were taken from patients. Biochemical, hematological investigations are done in the clinical pathology department of the hospital and paper reports are sent to respective patients' files. Laboratory measurements were collected for analysis which is available in the file of deceased patients in the record section.
- Conditions
- Covid19
- Keywords
- COVID19, Clinical Characteristics, Deceased
- Medical subject headings
- COVID-19, Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Characteristics
Demography, Clinical presentation, Treatment
Measured: 03/05/2020 to 31/08/20
Secondary outcomes (1)
Duration from admission to death
Duration of Hospitalization from admission to death in different comorbidity and disease severity
Measured: 03/05/2020 to 31/08/20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jul 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhaka Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Mahfuzul Hoque, Dhaka Medical College
- Investigators
- Mohammad M Hoque, FCPS, Principal investigator, Assistant Professor of Medicine, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874792
- Sponsor's protocol ID
- ERC-DMC-ECC/2020/142
- Acronym
- COVID-19
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Deceased With COVID-19: Review of Medical Records in a Referral Hospital Dedicated for COVID-19
- ClinicalTrials.gov ID
- NCT04874792
- Acronym / sponsor ID
- COVID-19 / ERC-DMC-ECC/2020/142
- Conditions
- Covid19
- Keywords
- COVID19, Clinical Characteristics, Deceased
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Dhaka Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 May 2021 (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.
This study aims to describe the clinical characteristics of patients who died from COVID-19 in the largest hospital in Bangladesh to understand the risk associated with COVID-19 related mortality in this region. This is a retrospective study where a review of hospital records of patients will be done who died from COVID-19 in Dhaka Medical College Hospital from 3rd May to 31 August 2020. All available demographic, clinical, laboratory information, radiological feature, and patients' management will be retrieved from the record section to be analyzed and described.
Detailed description
In this retrospective observational study, every consecutive patient who died and tested positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Dhaka Medical College Hospital from 2nd May 2020 to 31 August 2020 were included. The paper files of patients were retrieved from the record section of the hospital as only a paper-based recording is maintained in the hospital. Patients with suspected COVID-19 were excluded from the study who tested negative for Reverse Transcriptase Polymerase Chain Reaction (RT PCR for SARS-CoV-2).
A preformed case record form (CRF) was used to collect all available demographic, clinical information including presentation, investigation, and treatment from hospital paper file from the record section. The severity of disease for COVID-19 was classified according to National Guidelines on Clinical Management of COVID-19 Version 8.0, 5 November 2020. The mild disease was defined as an individual with COVID-19 with prodromal symptoms without dyspnea and radiological abnormality. The moderate disease was defined as abnormal chest imaging with the saturation of oxygen ≥ 90% and severe disease was denied as saturation of oxygen less than 90%. All data were summarized, analyzed with SPPS 26.
RT PCR for SARS-CoV-2 assay is done in the virology department of Dhaka Medical College to detect SARS-Cov-2 RNA from samples taken from suspected patients. Nasopharyngeal swabs and the oropharyngeal swab were taken from patients. Biochemical, hematological investigations are done in the clinical pathology department of the hospital and paper reports are sent to respective patients' files. Laboratory measurements were collected for analysis which is available in the file of deceased patients in the record section.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients died from COVID-19 in Dhaka Medical College Hospital confirmed by Real-Time reverse transcription Polymerase Chain Reaction during the period from 3rd May 2020 to 31st August 2020.
Key inclusion criteria (1 listed)
- All Patients died from COVID-19 confirmed with rt PCR for SARS-CoV-2
Key exclusion criteria (2 listed)
- Suspected COVID-19 patients negative for rt PCR for SARS-CoV-2 and
- Age less than 14 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Characteristics
Time frame: 03/05/2020 to 31/08/20
Demography, Clinical presentation, Treatment
1 secondary outcome
Duration from admission to death
Time frame: 03/05/2020 to 31/08/20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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.
Mohammad M Hoque, FCPS principal investigator
Assistant Professor of Medicine, Dhaka Medical College
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 Covid19, run by Dhaka Medical College 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 1 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 6 May 2021. 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?
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?
Clinical Characteristics (time frame: 03/05/2020 to 31/08/20). 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 6 May 2021.