Association of Comorbidities With COVID19

• Conditions: COVID19
• Interventions: Diagnostic Test: realtime PCR

• Registration Number: NCT04459390
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-05
• Study First Submitted QC: 2020-07-05
• Study First Posted: 2020-07-07
• Study Start: 2020-07-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06
• Primary Completion: 2020-10-20
• Study Completion: 2020-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.

Exclusion Criteria

• no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID19 with comorbidities	realtime PCR	Patients with COVID19 with at least one of the following comorbidities: 1. Hypertension 2. Diabetes 3. Cardiovascular disease 4. Chronic pulmonary disease 5. Obesity 6. Chronic liver disease 7. Chronic kidney disease 8. Collagen vascular disease 9. Autoimmune disease 10. Malignancy
COVID19 without comorbidities	realtime PCR	Patients with COVID19 without any of the previously mentioned comorbidities

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt