Comorbidities And Complications Associated With Covid-19 Infection

Covid19 Clinical Trial

Official title:

Comorbidities And Complications Associated With Covid-19 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04563442
• Other study ID #: covid 19
• Status: Not yet recruiting
• Start date: August 25, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: June 2022
• Source: Assiut University
• Contact: Mahmoud Gamal hussein
• Phone: 01004025057
• Email: memog919[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

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. 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.

According to the latest reports, the clinical manifestations of COVID-19 are heterogeneous. 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. 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. As with influenza, SARS-CoV and Middle East Respiratory Syndrome coronavirus (MERS-CoV), COVID-19 is more readily predisposed to respiratory failure and death in susceptible patients.

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. Mortality rates of COVID-19 are lower than SARS and Middle East Respiratory Syndrome (MERS); 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 25, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• complication
complication co morbidities

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Booth CM, Matukas LM, Tomlinson GA, Rachlis AR, Rose DB, Dwosh HA, Walmsley SL, Mazzulli T, Avendano M, Derkach P, Ephtimios IE, Kitai I, Mederski BD, Shadowitz SB, Gold WL, Hawryluck LA, Rea E, Chenkin JS, Cescon DW, Poutanen SM, Detsky AS. Clinical feat — View Citation

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15 — View Citation

Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, — View Citation

Gao HN, Lu HZ, Cao B, Du B, Shang H, Gan JH, Lu SH, Yang YD, Fang Q, Shen YZ, Xi XM, Gu Q, Zhou XM, Qu HP, Yan Z, Li FM, Zhao W, Gao ZC, Wang GF, Ruan LX, Wang WH, Ye J, Cao HF, Li XW, Zhang WH, Fang XC, He J, Liang WF, Xie J, Zeng M, Wu XZ, Li J, Xia Q, — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 20 — View Citation

Layton DS, Choudhary A, Bean AGD. Breaking the chain of zoonoses through biosecurity in livestock. Vaccine. 2017 Oct 20;35(44):5967-5973. doi: 10.1016/j.vaccine.2017.07.110. Epub 2017 Aug 18. Review. — View Citation

Mauskopf J, Klesse M, Lee S, Herrera-Taracena G. The burden of influenza complications in different high-risk groups: a targeted literature review. J Med Econ. 2013;16(2):264-77. doi: 10.3111/13696998.2012.752376. Epub 2012 Dec 4. Review. — View Citation

Placzek HE, Madoff LC. Association of age and comorbidity on 2009 influenza A pandemic H1N1-related intensive care unit stay in Massachusetts. Am J Public Health. 2014 Nov;104(11):e118-25. doi: 10.2105/AJPH.2014.302197. Epub 2014 Sep 11. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):106 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of different comorbidities and covid-19 infection' complications on patient's outcome	Identifying characters of patients with covid-19 whose are susceptible to have different complications during the course of the disease.	baseline