Covid19NCT04488588
Survival and 30-days Hospital Outcome in COVID-19 Patients in Upper Egypt
An observational study of Covid19 and Coronavirus Disease, run by Assiut University at 2 sites in Egypt.
Trial summary
Through history, there have been plenty of pandemics however; the social response to corona virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals are living in social segregation during this mother of all pandemics. Read more about this study
- Who is it for?
- Ages 36 to 63 years
- Conditions the study is for
- Covid19, Coronavirus Disease, SARS-CoV-2
- What is being tested?
- Kaplan Meier analysis
- How many people
- 1,064 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Mar 2020to 1 Jul 2020
- 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 36 to 63 years
- All sexes
- Adult
Study population: All cases had confirmed COVID-19 infection (based on PCR, chest HRCT, CBC, CRP, Ferritin levels) and received standardized treatment protocols of Ministry of Health and Population based on disease severity.
Who may be able to join
- This study included 1064 patients consecutively admitted to isolation hospitals in Upper Egypt during the period from 22 March to 23 June 2020
Who cannot join
- only hospitalized confirmed cases of COVID-19 were included.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Survival and 30-days Hospital Outcome in Hospitalized COVID-19 Patients in Upper Egypt: Multi-center Study
Through history, there have been plenty of pandemics however; the social response to corona virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals are living in social segregation during this mother of all pandemics.
Initially described in China in December 2019, severe acute respiratory syndrome caused by corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new pandemic is injuring not only health organizations of several countries but also the financial prudence universal.
Defining the clinical features and associated outcomes of patients diagnosed with coronavirus disease (COVID-19) is fundamental to improving our understanding and adequate management of this illness. Several articles have recently been published, describing the clinical features and outcomes of retrospective individuals with COVID-19
- Conditions
- Covid19, Coronavirus Disease, SARS-CoV-2
- Being tested
- Kaplan Meier analysis
- Keywords
- COVID-19, Survival, 30- Days Hospital outcome, outcome
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaplan Meier analysisOther
Kaplan Meier survival analysis was conducted to calculate the cumulative overall survival rates using Log Rank test for comparison between age groups
What is being measured
The primary outcome is the main question the study is designed to answer.
number of co-morbidities in hospitalized patients with COVID-19
Determinants of survival in studied covid-19 patients admitted to hospitals
Measured: one month
causes of ICU admission
Determinants of ICU admission in hospitalized patients with COVID-19
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start15 Mar 2020
- Primary completion1 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 1,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
- Investigators
- Aliae Mohamed-Hussein, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488588
- Sponsor's protocol ID
- AssiutU17
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and 30-days Hospital Outcome in Hospitalized COVID-19 Patients in Upper Egypt: Multi-center Study
- ClinicalTrials.gov ID
- NCT04488588
- Acronym / sponsor ID
- AssiutU17
- Conditions
- Covid19, Coronavirus Disease, SARS-CoV-2
- Keywords
- COVID-19, Survival, 30- Days Hospital outcome, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,064 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 28 Jul 2020 (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.
Through history, there have been plenty of pandemics however; the social response to corona virus disease (COVID-19) is unparalleled. It is assessed that almost four billion individuals are living in social segregation during this mother of all pandemics.
Initially described in China in December 2019, severe acute respiratory syndrome caused by corona virus 2 (SARS-CoV-2) has spread all over the world and by 18th July 2020- there was an emergent figure of 13,824,739 confirmed cases and 591.666 losses reported to the WHO. To date, Egypt reported slightly over 82,000 confirmed COVID-19 cases with 3858 deaths. The new pandemic is injuring not only health organizations of several countries but also the financial prudence universal.
Defining the clinical features and associated outcomes of patients diagnosed with coronavirus disease (COVID-19) is fundamental to improving our understanding and adequate management of this illness. Several articles have recently been published, describing the clinical features and outcomes of retrospective individuals with COVID-19
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 36 to 63 years
- Sex
- All
- Age groups
- Adult
- Study population
- All cases had confirmed COVID-19 infection (based on PCR, chest HRCT, CBC, CRP, Ferritin levels) and received standardized treatment protocols of Ministry of Health and Population based on disease severity.
Key inclusion criteria (1 listed)
- This study included 1064 patients consecutively admitted to isolation hospitals in Upper Egypt during the period from 22 March to 23 June 2020
Key exclusion criteria (1 listed)
- only hospitalized confirmed cases of COVID-19 were included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaplan Meier analysisKaplan Meier survival analysis was conducted to calculate the cumulative overall survival rates using Log Rank test for comparison between age groups | Other | – |
Primary outcome
number of co-morbidities in hospitalized patients with COVID-19
Time frame: one month
Determinants of survival in studied covid-19 patients admitted to hospitals
causes of ICU admission
Time frame: one month
Determinants of ICU admission in hospitalized patients with COVID-19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Aliae Mohamed-Hussein, MD principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Coronavirus Disease, run by Assiut University at 2 sites 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: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of co-morbidities in hospitalized patients with COVID-19 (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.