Covid19NCT04765254
COVID-19 Infection in Diabetic Patients
An observational study of Covid19 and Diabete Type 2, run by Cairo University at 1 site in Egypt.
Trial summary
It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Covid19, Diabete Type 2, Non Diabetic Patients
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 10 Apr 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients infected with COVID-19 either diabetic or have no comorbidities, inpatients
Who may be able to join
- Patients infected with COVID-19 male or female 30 years old or more inpatients
Who cannot join
- have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University teaching hospitals
Cairo, Kasr Al Ainy, 11311
Amal Ahmed, PhD, +201224847367, amalahmedhcp@yahoo.com
Dalia Zaafar, PhD, +201117922833, dr.moda88@gmail.com
About this study
Official title: Clinical Features of Diabetic Patients With COVID-19 Infection
It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients
Read the detailed description
Diabetic patients infected with SAR-COV-19 were reported to have worse prognosis and faster deterioration in addition to higher rate for ICU admission when compared to other infected patients. In this study authors aim to investigate the certain cause for their case deterioration to be modified for better prognosis
- Conditions
- Covid19, Diabete Type 2, Non Diabetic Patients, Chest CT Scan
- Being tested
- no intervention as it is an observational study
- Keywords
- COVID-19, prognosis, mortality rate, Diabetes Mellitus
- Medical subject headings
- COVID-19, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention as it is an observational studyOther
both groups will be monitored for the disease progress or deterioration and mortality rate
| Study group | Role | What they receive |
|---|---|---|
| control group | COVID-19 infected patients with no other comorbidities and they take the routine protocol from the Egyptian ministry of health Receives: Other: no intervention as it is an observational study | |
| diabetic group | COVID-19 infected patients with diabetes comorbidity and they receive the routine protocol for covid treatment in addition to their hypoglycemic drugs Receives: Other: no intervention as it is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of bad prognosis cause for covid-19 diabetic patients
number of diabetic patients with deteriorated case and to find the best hypoglycemic drug used for diabetic patients with covid-19 infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 Feb 2021
- Primary completion20 Mar 2021 (estimated)
- Study completion10 Apr 2021 (estimated)
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 Cairo 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia K. Zaafar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765254
- Sponsor's protocol ID
- ITH00131
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features of Diabetic Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04765254
- Acronym / sponsor ID
- ITH00131
- Conditions
- Covid19, Diabete Type 2, Non Diabetic Patients, Chest CT Scan
- Keywords
- COVID-19, prognosis, mortality rate, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Mar 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 21 Feb 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.
It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients
Detailed description
Diabetic patients infected with SAR-COV-19 were reported to have worse prognosis and faster deterioration in addition to higher rate for ICU admission when compared to other infected patients. In this study authors aim to investigate the certain cause for their case deterioration to be modified for better prognosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: no intervention as it is an observational studyCOVID-19 infected patients with no other comorbidities and they take the routine protocol from the Egyptian ministry of health |
| diabetic group | – | Other: no intervention as it is an observational studyCOVID-19 infected patients with diabetes comorbidity and they receive the routine protocol for covid treatment in addition to their hypoglycemic drugs |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients infected with COVID-19 either diabetic or have no comorbidities, inpatients
Key inclusion criteria (1 listed)
- Patients infected with COVID-19 male or female 30 years old or more inpatients
Key exclusion criteria (1 listed)
- have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old
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 |
|---|---|---|
| no intervention as it is an observational studyboth groups will be monitored for the disease progress or deterioration and mortality rate | Other | control group, diabetic group |
Primary outcome
Investigation of bad prognosis cause for covid-19 diabetic patients
Time frame: 30 days
number of diabetic patients with deteriorated case and to find the best hypoglycemic drug used for diabetic patients with covid-19 infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
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 and Diabete Type 2, run by Cairo 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 21 Feb 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 Dalia Zaafar, PhD (+201117922833, dr.moda88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of bad prognosis cause for covid-19 diabetic patients (time frame: 30 days). 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 21 Feb 2021.