Coronavirus Disease (COVID-19)NCT04584606
Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients
An observational study of Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
Trial summary
COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- Lab workup (on admission and regularly during follow up).
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jun 2020to 30 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
Who may be able to join
- Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
- Standard of care arm of the ongoing clinical trials will be included in our study.
Who cannot join
- mild cases who don't need hospitalization
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
Fatma Soliman E Ebeid, 01095569596, dr.fatma_ebeid@yahoo.com
About this study
Official title: Ain Shams University Experience: Clinical Characteristics and Outcome Determinants of Hospitalized Covid-19 Patients at Ain Shams University Obour Hospital
COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome
Read the detailed description
Investigators will convey the Ain Shams University experience as the first university in Egypt to designate one of its hospitals (Ain Shams University Obour Hospital) for management of confirmed COVID19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. It is a retrospective observational cohort study at Ain Shams University Obour Hospital. All adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2)will be included.
Clinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- Lab workup (on admission and regularly during follow up).
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab workup (on admission and regularly during follow up).Diagnostic test
Also called culture, imaging
Complete blood count with differential leucocytic count. Absolute lymphocytic and neutrophilic count. Liver functions: Aspartate transaminase and Alanine transaminase . Renal functions: Blood urea nitrogen, serum Creatinine. HbA1C. C-reactive protein (quantitative). Serum ferritin level. D - dimer level (quantitative). Coagulation profile (Prothrombin time/ Partial thromboplastin time/ International normalized ratio).
Troponin level. Arterial blood gases when needed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery
Recovery defined as resolution of fever without the use of antipyretics, improvement of respiratory symptoms (e.g., cough, dyspnea) and no need for supplemental oxygen
Measured: Until patient is discharged or up to 12 weeks whichever comes first
Mortality
All cause mortality
Measured: Until patient is discharged or up to 12 weeks whichever comes first
Secondary outcomes (3)
Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative.
Detected by Polymerase Chain Reaction (PCR) test for nasopharyngeal swab
Measured: Until patient is discharged or up to 12 weeks whichever comes first
Radiological progression of the COVID 19 disease
detected by measuring the extent of pulmonary lesion in high resolution computed tomography (HRCT) of the chest
Measured: Until patient is discharged or up to 12 weeks whichever comes first
Functional progression of the COVID 19 disease
increase oxygen demands detected by arterial blood gases analysis and/or pulse oximeter
Measured: Until patient is discharged or up to 12 weeks whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start27 Jun 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf A Elmaraghy, Ain Shams University
- Investigators
- Ashraf Elmaraghy, Principal investigator, Ain Shams University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584606
- Sponsor's protocol ID
- FMASU P30/ 2020
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ain Shams University Experience: Clinical Characteristics and Outcome Determinants of Hospitalized Covid-19 Patients at Ain Shams University Obour Hospital
- ClinicalTrials.gov ID
- NCT04584606
- Acronym / sponsor ID
- FMASU P30/ 2020
- Conditions
- Coronavirus Disease (COVID-19)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 14 Oct 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.
COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome
Detailed description
Investigators will convey the Ain Shams University experience as the first university in Egypt to designate one of its hospitals (Ain Shams University Obour Hospital) for management of confirmed COVID19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. It is a retrospective observational cohort study at Ain Shams University Obour Hospital. All adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2)will be included.
Clinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
Key inclusion criteria (2 listed)
- Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
- Standard of care arm of the ongoing clinical trials will be included in our study.
Key exclusion criteria (1 listed)
- mild cases who don't need hospitalization
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 |
|---|---|---|
| Lab workup (on admission and regularly during follow up).Also: culture, imagingComplete blood count with differential leucocytic count. Absolute lymphocytic and neutrophilic count. Liver functions: Aspartate transaminase and Alanine transaminase . Renal functions: Blood urea nitrogen, serum Creatinine. HbA1C. C-reactive protein (quantitative). Serum ferritin level. D - dimer level (quantitative). Coagulation profile (Prothrombin time/ Partial thromboplastin time/ International normalized ratio). Troponin level. Arterial blood gases when needed. | Diagnostic test | – |
Primary outcome
Recovery
Time frame: Until patient is discharged or up to 12 weeks whichever comes first
Recovery defined as resolution of fever without the use of antipyretics, improvement of respiratory symptoms (e.g., cough, dyspnea) and no need for supplemental oxygen
Mortality
Time frame: Until patient is discharged or up to 12 weeks whichever comes first
All cause mortality
3 secondary outcomes
Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative.
Time frame: Until patient is discharged or up to 12 weeks whichever comes first
Radiological progression of the COVID 19 disease
Time frame: Until patient is discharged or up to 12 weeks whichever comes first
Functional progression of the COVID 19 disease
Time frame: Until patient is discharged or up to 12 weeks whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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.
Ashraf Elmaraghy principal investigator
Ain Shams University, Faculty of Medicine
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 Coronavirus Disease (COVID-19), run by Ain Shams 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 2 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 14 Oct 2020. 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 Ashraf Elmaraghy (+20 100 177 0703, ashrafelmaraghy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery (time frame: Until patient is discharged or up to 12 weeks whichever comes first). 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 14 Oct 2020.