Clinical trial NCT04860232: Risks and Outcomes Among COVID-19 Patients Admitted to Assiut University Hospital.
Official title: Risks and Outcomes Among COVID-19 Patients Admitted to Assiut University Hospital.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Cases aged 18 years and over. Cases diagnosed as COVID-19 by radiology or with positive PCR. Cases admitted to Assiut University Hospitals.

Brief summary: The aim of this study is to assess risks and outcomes among COVID-19 patients admitted to Assiut University Hospitals.

Detailed description: Corona Virus comprises a large group of viruses, that are common in human beings as well animals. There are seven different strains of corona virus, one of them is SARS-COV-2 (the novel coronavirus that causes coronavirus disease 2019, COVID-19) \[1\].

On 11th March 2020. The World Health Organization declared the international spread of COVID-19 considering it a global pandemic. On 3rd July 2020. WHO declared the total number of confirmed cases of COVID-19 patients is 10,720,450 and number of deaths is 517,340 cases worldwide while in Egypt number of confirmed cases is 71,299 and number of deaths is 3,120 \[2\].

The largest disparity found was by age. People who were 80 or older were seventy times more likely to die than those under 40. Higher in males than females. Higher in those living in deprived area than those living in the least deprived and higher in Black, Asian and Minority Ethnic groups than in White ethnic groups \[3\].

It was found that Demographic Characteristics, underlying health state and clinical presentation affect outcome of COVID-19 patients. For example, incidence highest among people aged \> 80 years. Hospitalization is six times higher among patients with reported underlying comorbidity (45.4%) than those without reported underlying comorbidity (7.6%). Deaths were 12 times higher in patients with reported underlying comorbidity (19.5%) compared to those without underlying comorbidity (1.6%) \[4,5\].

Human to human transmission occurs via droplets, contaminated hands or surfaces with Incubation Period 2-14 days after exposure to virus. clinical presentation include: fever, cough, shortness of breath, new loss of taste and smell, body ache, headache, sore throat and diarrhea \[6\].

Real time PCR used as diagnostic tool for COVID-19, other laboratory findings include leukopenia, lymphopenia, elevated CRP, elevated D-Dimer, high cytokine levels (IL-2R, IL-6, IL-10, and TNF-α), and high lactate dehydrogenase level were significantly associated with severe COVID-19 on admission \[7\]\[8\].

Computed Tomography (CT Chest) used for assessment severity of lung affection and follow up. Typical CT findings include Ground Glass Opacities: bilateral, subpleural and peripheral, crazy paving appearance (GGO and inter-/intra-lobular septal thickening), Air space consolidation and bronchovascular thickenings \[9\].

The main therapies used in treatment include Home Isolation, drugs: antibiotic, antiviral, corticosteroids, multivitamins and anticoagulants, O2 therapy, non invasive intervention e.g.: CPAP and invasive intervention e.g.: Mechanical Ventilation. Outcome of patients depend on several factors e.g.: comorbidities, previous lung state, early diagnosis and start of treatment \[10\].

Eligibility criteria: Inclusion Criteria:

* Cases aged 18 years and over. Cases diagnosed as COVID-19 by radiology or with positive PCR. Cases admitted to Assiut University Hospitals.

Exclusion Criteria:

* Cases less than 18 years old. Cases diagnosed as COVID-19 and discharged from emergency department for Home Isolation. Cases express a dissent from the use of their data in this study.

Primary outcomes:
measure: study relation between age and infection with covid 19 amd mortality rate
timeFrame: baseline
Secondary outcomes:
measure: study relation between sex and infection with covid 19 amd mortality rate
timeFrame: baseline
measure: study relation between previous comorbidties and infection with covid 19 amd mortality rate
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Maha k Ghanem, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: hoda A makhlouf, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ali A hassan, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Asmaa M soliman, assistant prof
role: STUDY_DIRECTOR
References:
citation: CDC COVID-19 Response Team. Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) - United States, February 12-March 16, 2020. MMWR Morb Mortal Wkly Rep. 2020 Mar 27;69(12):343-346. doi: 10.15585/mmwr.mm6912e2.
citation: Garg S, Kim L, Whitaker M, O'Halloran A, Cummings C, Holstein R, Prill M, Chai SJ, Kirley PD, Alden NB, Kawasaki B, Yousey-Hindes K, Niccolai L, Anderson EJ, Openo KP, Weigel A, Monroe ML, Ryan P, Henderson J, Kim S, Como-Sabetti K, Lynfield R, Sosin D, Torres S, Muse A, Bennett NM, Billing L, Sutton M, West N, Schaffner W, Talbot HK, Aquino C, George A, Budd A, Brammer L, Langley G, Hall AJ, Fry A. Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 - COVID-NET, 14 States, March 1-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):458-464. doi: 10.15585/mmwr.mm6915e3.
citation: Zhai P, Ding Y, Wu X, Long J, Zhong Y, Li Y. The epidemiology, diagnosis and treatment of COVID-19. Int J Antimicrob Agents. 2020 May;55(5):105955. doi: 10.1016/j.ijantimicag.2020.105955. Epub 2020 Mar 28.
citation: Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.
citation: Lu Xuefong, Gong Wei, Wang Li, Li Liang, Xie Baojun. Clinical features and high resolution CT imaging findings of Preliminary diagnosis novel coronavirus pneumonia. Chin J Radiol 2020,54.
citation: Li X, Xu S, Yu M, Wang K, Tao Y, Zhou Y, Shi J, Zhou M, Wu B, Yang Z, Zhang C, Yue J, Zhang Z, Renz H, Liu X, Xie J, Xie M, Zhao J. Risk factors for severity and mortality in adult COVID-19 inpatients in Wuhan. J Allergy Clin Immunol. 2020 Jul;146(1):110-118. doi: 10.1016/j.jaci.2020.04.006. Epub 2020 Apr 12.