Characteristics DiseasesCOVID-19NCT04339322
Characteristics and Outcome of Coronavirus Disease 2019 (COVID-19) in Egypt
An observational study of Characteristics Diseases and Outcome, Fatal, run by Assiut University.
Trial summary
The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Egypt is one of the countries that has been infected by Covid-19. The characteristics of clinical presentation, laboratory and radiological data are not yet studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Characteristics Diseases, Outcome, Fatal
- What is being tested?
- Follow up
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 30 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with clinical presentation and confirmed as Covid-19 according to the definition of Egyptian Ministry of Health.
Who may be able to join
- Patients with diagnosis of Covid-19 .
Who cannot join
- Patients refuse to participate in the study
About this study
Official title: Characteristics and Outcome of COVID-19 Among Egyptian Patients
The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Egypt is one of the countries that has been infected by Covid-19. The characteristics of clinical presentation, laboratory and radiological data are not yet studied. Outcomes of covid-19 in Egypt also have not been described yet.
Read the detailed description
Patients admitted to Assiut University hospital, Al Rajhi liver hospital and other covid-19 Quarantine hospitals will be included. The characteristics of patients will be described such as demographic data; age, sex,history of contact to COVID-19 patients or traveling abroad and their clinical manifestation such as fever,cough,shortness of breath, sore throat, diarrhea. Laboratory data will also be included such as blood picture,D-Dimer, serum ferritin, creatinine, liver enzymes, oxygen saturation and covid-19 polymerase chain reaction (PCR). Radiological data will be described as regarding chest X-ray and/or computed tomography.
Patients will be followed until complications, improvement, transfer to another hospital or death and their outcome will be described.
- Conditions
- Characteristics Diseases, Outcome, Fatal
- Being tested
- Follow up
- Keywords
- Covid-19, characteristics, Outcome, Egypt
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
Follow up to assess the outcome until complications, improvement, death or being transferred to another quarantine hospital.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Covid-19 | Patients with clinical presentation and confirmed as Covid-19 according to the definition of Egyptian Ministry of Health Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics of Coronavirus Disease 2019 (COVID-19) in the cohort group
Sheet recording age, sex, co-morbidity,history of contact
Measured: 2 months
Clinical manifestations of Coronavirus Disease 2019 (COVID-19)
Sheet recording symptoms and signs
Measured: 2 month
Laboratory data of included Coronavirus Disease 2019 (COVID-19) cohort
blood picture,D-Dimer, creatinine, liver enzymes
Measured: 2 months
Radiological features of Coronavirus Disease 2019 (COVID-19) cohort
Chest x-ray and/or Computed tomography
Measured: 2 month
Secondary outcomes (1)
outcomes of Coronavirus Disease 2019 (COVID-19) infection in the cohort group
Data recording of the outcomes of treatment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Characteristics DiseasesStudies 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, Haidi Karam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339322
- Sponsor's protocol ID
- COVID-19 in Egypt
- Acronym
- COVID-19
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data prescribed in the study
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcome of COVID-19 Among Egyptian Patients
- ClinicalTrials.gov ID
- NCT04339322
- Acronym / sponsor ID
- COVID-19 / COVID-19 in Egypt
- Conditions
- Characteristics Diseases, Outcome, Fatal
- Keywords
- Covid-19, characteristics, Outcome, Egypt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 9 Apr 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.
The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Egypt is one of the countries that has been infected by Covid-19. The characteristics of clinical presentation, laboratory and radiological data are not yet studied. Outcomes of covid-19 in Egypt also have not been described yet.
Detailed description
Patients admitted to Assiut University hospital, Al Rajhi liver hospital and other covid-19 Quarantine hospitals will be included. The characteristics of patients will be described such as demographic data; age, sex,history of contact to COVID-19 patients or traveling abroad and their clinical manifestation such as fever,cough,shortness of breath, sore throat, diarrhea. Laboratory data will also be included such as blood picture,D-Dimer, serum ferritin, creatinine, liver enzymes, oxygen saturation and covid-19 polymerase chain reaction (PCR). Radiological data will be described as regarding chest X-ray and/or computed tomography.
Patients will be followed until complications, improvement, transfer to another hospital or death and their outcome will be described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Covid-19 | – | Other: Follow upPatients with clinical presentation and confirmed as Covid-19 according to the definition of Egyptian Ministry of Health |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with clinical presentation and confirmed as Covid-19 according to the definition of Egyptian Ministry of Health.
Key inclusion criteria (1 listed)
- Patients with diagnosis of Covid-19 .
Key exclusion criteria (1 listed)
- Patients refuse to participate in the study
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 |
|---|---|---|
| Follow upFollow up to assess the outcome until complications, improvement, death or being transferred to another quarantine hospital. | Other | Patients with Covid-19 |
Primary outcome
Demographics of Coronavirus Disease 2019 (COVID-19) in the cohort group
Time frame: 2 months
Sheet recording age, sex, co-morbidity,history of contact
Clinical manifestations of Coronavirus Disease 2019 (COVID-19)
Time frame: 2 month
Sheet recording symptoms and signs
Laboratory data of included Coronavirus Disease 2019 (COVID-19) cohort
Time frame: 2 months
blood picture,D-Dimer, creatinine, liver enzymes
Radiological features of Coronavirus Disease 2019 (COVID-19) cohort
Time frame: 2 month
Chest x-ray and/or Computed tomography
1 secondary outcome
outcomes of Coronavirus Disease 2019 (COVID-19) infection in the cohort group
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No. The data prescribed in the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Characteristics Diseases and Outcome, Fatal, run by Assiut University.
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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Demographics of Coronavirus Disease 2019 (COVID-19) in the cohort group (time frame: 2 months). The study lists 4 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 9 Apr 2020.