Clinical Characteristics of Deceased With COVID-19

Sponsor
Dhaka Medical College (Other)
Overall Status
Completed
CT.gov ID
NCT04874792
Collaborator
(none)
282
1
6
46.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    282 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Characteristics of Deceased With COVID-19: Review of Medical Records in a Referral Hospital Dedicated for COVID-19
    Actual Study Start Date :
    Jul 1, 2020
    Actual Primary Completion Date :
    Nov 30, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Characteristics [03/05/2020 to 31/08/20]

      Demography, Clinical presentation, Treatment

    Secondary Outcome Measures

    1. Duration from admission to death [03/05/2020 to 31/08/20]

      Duration of Hospitalization from admission to death in different comorbidity and disease severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dhaka Medical College Hospital Dhaka Bangladesh

    Sponsors and Collaborators

    • Dhaka Medical College

    Investigators

    • Principal Investigator: Mohammad M Hoque, FCPS, Assistant Professor of Medicine, Dhaka Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammad Mahfuzul Hoque, Assistant Professor, Dhaka Medical College
    ClinicalTrials.gov Identifier:
    NCT04874792
    Other Study ID Numbers:
    • ERC-DMC-ECC/2020/142
    First Posted:
    May 6, 2021
    Last Update Posted:
    May 6, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohammad Mahfuzul Hoque, Assistant Professor, Dhaka Medical College
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2021