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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04874792
Other study ID # ERC-DMC-ECC/2020/142
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2020

Study information

Verified date May 2021
Source Dhaka Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date December 31, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - All Patients died from COVID-19 confirmed with rt PCR for SARS-CoV-2 Exclusion Criteria: - Suspected COVID-19 patients negative for rt PCR for SARS-CoV-2 and - Age less than 14 year

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Bangladesh Dhaka Medical College Hospital Dhaka

Sponsors (1)

Lead Sponsor Collaborator
Dhaka Medical College

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Characteristics Demography, Clinical presentation, Treatment 03/05/2020 to 31/08/20
Secondary Duration from admission to death Duration of Hospitalization from admission to death in different comorbidity and disease severity 03/05/2020 to 31/08/20
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