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Comorbidities And Complications Associated With Covid-19 Infection

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ClinicalTrials.gov Identifier: NCT04563442
Recruitment Status : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Gamal Hussein, Assiut University

Brief Summary:
To evaluate the spectrum of comorbidities and complications and its impact on the clinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).

Condition or disease Intervention/treatment
Covid19 Other: complication

Detailed Description:

Severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) is a coronavirus with human infection designated as COVID-19 by the World Health Organization. Bats and birds serve as the typical coronavirus hosts, with zoonotic spread and a long-documented history of animal-animal-human transmission. [1] Since November 2019, the rapid outbreak of coronavirus disease 2019 (COVID-19), which arose from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has recently become a public health emergency of international concern [2]. COVID-19 has contributed to an enormous adverse impact globally.

As of 10 March 2020 there have been 113702 laboratory confirmed cases and 4012 deaths globally [3].

According to the latest reports, the clinical manifestations of COVID-19 are heterogeneous [4-6]. On admission, 20-51% of patients were reported as having at least one comorbidity, with diabetes (10-20%), hypertension (10-15%) and other cardiovascular and cerebrovascular diseases (7-40%) being most common [4, 5, 7]. Previous studies have demonstrated that the presence of any comorbidity has been associated with a 3.4-fold increased risk of developing acute respiratory distress syndrome in patients with H7N9 infection [8]. As with influenza [9, 10], SARS-CoV [11] and Middle East Respiratory Syndrome coronavirus (MERS-CoV) [12], COVID-19 is more readily predisposed to respiratory failure and death in susceptible patients [5, 6].

Although it is well documented that COVID-19 is primarily manifested as a respiratory tract infection, emerging data indicate that it should be regarded as a systemic disease involving multiple systems, including cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune system. [13] Mortality rates of COVID-19 are lower than SARS and Middle East Respiratory Syndrome (MERS) [14]; however, COVID-19 is more lethal than seasonal flu.

Older people and those with comorbidities are at increased risk of death from COVID-19, but younger people without major underlying diseases may also present with potentially lethal complications such as fulminant myocarditis and disseminated intravascular coagulopathy (DIC) [15].

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Comorbidities And Complications Associated With Covid-19 Infection
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : February 25, 2023

Group/Cohort Intervention/treatment
covid 19
complications and comorbidities
Other: complication
complication co morbidities




Primary Outcome Measures :
  1. Identifying different co-morbidities and complications of covid-19 infection. [ Time Frame: baseline ]
    Identifying and management of different co-morbidities and complications of covid-19 infection.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
200 patients confirmed to have covid 19 infection
Criteria

Inclusion Criteria:

Patients presented by respiratory symptom and admitted to Assuit university hospitals in wards and intensive care units due to COVID-19 according to WHO and Egyptian Ministry of Health and Population (MOH) definitions with positive PCR result.

Exclusion Criteria:

  • Negative PCR result for suspicious cases of Covid-19,
  • Patients refusing to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563442


Contacts
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Contact: Mahmoud Gamal hussein 01004025057 memog919@gmail.com
Contact: Gamal Mohamed Rabee 01221729476 Gamalagmy135@gmail.com

Sponsors and Collaborators
Assiut University
Publications of Results:

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Responsible Party: Mahmoud Gamal Hussein, Assiut University
ClinicalTrials.gov Identifier: NCT04563442    
Other Study ID Numbers: covid 19
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection