Association of Comorbidities With COVID19

COVID19 Clinical Trial

Official title:

Impact of Comorbidities on COVID19 Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459390
• Other study ID #: COVID19
• Status: Recruiting
• Start date: July 20, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Hebatallah Hassan
• Phone: 01022182086
• Email: heba.ismailhassan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no exclusion criteria

Related Conditions & MeSH terms

• COVID19

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Badawi A, Ryoo SG. Prevalence of comorbidities in the Middle East respiratory syndrome coronavirus (MERS-CoV): a systematic review and meta-analysis. Int J Infect Dis. 2016 Aug;49:129-33. doi: 10.1016/j.ijid.2016.06.015. Epub 2016 Jun 21. Review. — View Citation

Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10. — View Citation

Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recovery/ ICU admission/ need for mechanical ventilation	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.	Baseline
Primary	Time to improvement	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.	Baseline