Covid19NCT04860245
Risks and Outcomes Among COVID-19 Patients Admitted to Assiut University Hospitals.
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to assess risks and outcomes among COVID-19 patients admitted to Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Covid19
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Cases aged 18 years and over. Cases diagnosed as COVID-19 by radiology or with positive PCR. Cases admitted to Assiut University Hospitals.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Maha K. Ghanem, professor contact
About this study
The aim of this study is to assess risks and outcomes among COVID-19 patients admitted to Assiut University Hospitals.
Read the 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].
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between age and INFECTION WITH COVID19 mortality rate of covid19
ANALYSIS AGE OF PEOPLE GET INFECTED WITH COVID 19 AND MORTALITY RATE
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Moustafa, Assiut University
- Investigators
- Maha Kamel Ghanem, professor, Study director, Assiut Universityhoda A. makhlouf, professor, Study director, Assiut UniversityAli A. hassan, professor, Study director, Assiut UniversityAsmaa M. soliman, assistant prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860245
- Sponsor's protocol ID
- Risks and Outcomes ofCOVID-
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
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.
PubMed 32234468Li 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.
PubMed 32294485CDC 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.
PubMed 32214079Garg 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.
PubMed 32298251
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks and Outcomes Among COVID-19 Patients Admitted to Assiut University Hospitals.
- ClinicalTrials.gov ID
- NCT04860245
- Acronym / sponsor ID
- Risks and Outcomes ofCOVID-
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Cases aged 18 years and over. Cases diagnosed as COVID-19 by radiology or with positive PCR. Cases admitted to Assiut University Hospitals.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relation between age and INFECTION WITH COVID19 mortality rate of covid19
Time frame: baseline
ANALYSIS AGE OF PEOPLE GET INFECTED WITH COVID 19 AND MORTALITY RATE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- BackgroundLu 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.
- Background: PubMed 32234468Zhai 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.
- Background: PubMed 32294485Li 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.
- Background: PubMed 32214079CDC 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.
- Background: PubMed 32298251Garg 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.
- World Health Organization Coronavirus Disease (COVID-19) Dashboard.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha K. Ghanem, professor contact
Maha Kamel Ghanem, professor study director
Assiut University
hoda A. makhlouf, professor study director
Assiut University
Ali A. hassan, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamd M. Moustafa, resident (2001023420225, mohamedmamdouh15794@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between age and INFECTION WITH COVID19 mortality rate of covid19 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860245, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.