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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

Tracking Information
First Submitted Date September 23, 2020
First Posted Date September 24, 2020
Last Update Posted Date September 24, 2020
Estimated Study Start Date October 15, 2020
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 23, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comorbidities And Complications Associated With Covid-19 Infection
Official Title Comorbidities And Complications Associated With Covid-19 Infection
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).
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].

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 200 patients confirmed to have covid 19 infection
Condition Covid19
Intervention Other: complication
complication co morbidities
Study Groups/Cohorts covid 19
complications and comorbidities
Intervention: Other: complication
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 23, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 25, 2023
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mahmoud Gamal hussein 01004025057 memog919@gmail.com
Contact: Gamal Mohamed Rabee 01221729476 Gamalagmy135@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04563442
Other Study ID Numbers covid 19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mahmoud Gamal Hussein, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date September 2020