Association of Comorbidities With COVID19

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04459390
Collaborator
(none)
100
1
4
24.7

Study Details

Study Description

Brief Summary

Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive care, invasive ventilation or death.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: realtime PCR

Detailed Description

COVID19 is a new emerging, rapidly disseminating disease that consuming most of resources of efficient healthcare systems, and several hospitals, worldwide, are currently experiencing a shortage of ICU beds for critically ill patients with COVID-19 pneumonia.

A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need hospital and/or ICU admission.

One of the most alarming clinical parameters in general is the presence comorbidities. The underlying diseases including hypertension, diabetes mellitus, respiratory system disease and cardiovascular disease, may be risk factors for severe COVID-19 patients with adverse outcomes compared with non-severe patients. Obesity is also a risk factor for COVID-19 severity with increased need to mechanical ventilation.

Chronic diseases share several features with infectious disorders, such as the proinflammatory state, and the attenuation of the innate immune response which may be linked etiologically to its pathogenesis.

Aim of the study:to assess the impact of comorbidities in patients with diagnosis of Covid-19 on outcome, in order to find the predictors of prolonged hospital stay, need for ICU admission or poor outcome

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Impact of Comorbidities on COVID19 Outcome
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Oct 20, 2020
Anticipated Study Completion Date :
Nov 20, 2020

Arms and Interventions

Arm Intervention/Treatment
COVID19 with comorbidities

Patients with COVID19 with at least one of the following comorbidities: Hypertension Diabetes Cardiovascular disease Chronic pulmonary disease Obesity Chronic liver disease Chronic kidney disease Collagen vascular disease Autoimmune disease Malignancy

Diagnostic Test: realtime PCR
Detection of SARS-CoV-2 genes by realtime PCR

COVID19 without comorbidities

Patients with COVID19 without any of the previously mentioned comorbidities

Diagnostic Test: realtime PCR
Detection of SARS-CoV-2 genes by realtime PCR

Outcome Measures

Primary Outcome Measures

  1. Rate of recovery/ ICU admission/ need for mechanical ventilation [Baseline]

    The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.

  2. Time to improvement [Baseline]

    Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.
Exclusion Criteria:
  • no exclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hebatallah Hassan, dr, Assiut University
ClinicalTrials.gov Identifier:
NCT04459390
Other Study ID Numbers:
  • COVID19
First Posted:
Jul 7, 2020
Last Update Posted:
Aug 6, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2020