COVID19NCT04459390
Association of Comorbidities With COVID19
An observational study of COVID19, run by Assiut University at 1 site in Egypt.
Trial summary
Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive care, invasive ventilation or death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID19
- What is being tested?
- realtime PCR
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2020to 20 Nov 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. All patients will be subjected to full clinical assessment, some laboratory investigations which are potential marker of disease severity. Another studies include chest X ray and CT chest.
Who may be able to join
- Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Comorbidities on COVID19 Outcome
Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive care, invasive ventilation or death.
Read the detailed description
COVID19 is a new emerging, rapidly disseminating disease that consuming most of resources of efficient healthcare systems, and several hospitals, worldwide, are currently experiencing a shortage of ICU beds for critically ill patients with COVID-19 pneumonia.
A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need hospital and/or ICU admission.
One of the most alarming clinical parameters in general is the presence comorbidities. The underlying diseases including hypertension, diabetes mellitus, respiratory system disease and cardiovascular disease, may be risk factors for severe COVID-19 patients with adverse outcomes compared with non-severe patients. Obesity is also a risk factor for COVID-19 severity with increased need to mechanical ventilation.
Chronic diseases share several features with infectious disorders, such as the proinflammatory state, and the attenuation of the innate immune response which may be linked etiologically to its pathogenesis.
Aim of the study:to assess the impact of comorbidities in patients with diagnosis of Covid-19 on outcome, in order to find the predictors of prolonged hospital stay, need for ICU admission or poor outcome
- Conditions
- COVID19
- Being tested
- realtime PCR
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
realtime PCRDiagnostic test
Detection of SARS-CoV-2 genes by realtime PCR
| Study group | Role | What they receive |
|---|---|---|
| COVID19 with comorbidities | Patients with COVID19 with at least one of the following comorbidities:
1. Hypertension
2. Diabetes
3. Cardiovascular disease
4. Chronic pulmonary disease
5. Obesity
6. Chronic liver disease
7. Chronic kidney disease
8. Collagen vascular disease
9. Autoimmune disease
10. Malignancy Receives: Diagnostic Test: realtime PCR | |
| COVID19 without comorbidities | Patients with COVID19 without any of the previously mentioned comorbidities Receives: Diagnostic Test: realtime PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recovery/ ICU admission/ need for mechanical ventilation
The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.
Measured: Baseline
Time to improvement
Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start20 Jul 2020
- Primary completion20 Oct 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459390
- Sponsor's protocol ID
- COVID19
- Status last verified
- Aug 2020
- First submitted
- 5 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
PubMed 32173574Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10.
PubMed 32271993Badawi A, Ryoo SG. Prevalence of comorbidities in the Middle East respiratory syndrome coronavirus (MERS-CoV): a systematic review and meta-analysis. Int J Infect Dis. 2016 Aug;49:129-33. doi: 10.1016/j.ijid.2016.06.015. Epub 2016 Jun 21.
PubMed 27352628
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Comorbidities on COVID19 Outcome
- ClinicalTrials.gov ID
- NCT04459390
- Acronym / sponsor ID
- COVID19
- Conditions
- COVID19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 7 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.
Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive care, invasive ventilation or death.
Detailed description
COVID19 is a new emerging, rapidly disseminating disease that consuming most of resources of efficient healthcare systems, and several hospitals, worldwide, are currently experiencing a shortage of ICU beds for critically ill patients with COVID-19 pneumonia.
A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need hospital and/or ICU admission.
One of the most alarming clinical parameters in general is the presence comorbidities. The underlying diseases including hypertension, diabetes mellitus, respiratory system disease and cardiovascular disease, may be risk factors for severe COVID-19 patients with adverse outcomes compared with non-severe patients. Obesity is also a risk factor for COVID-19 severity with increased need to mechanical ventilation.
Chronic diseases share several features with infectious disorders, such as the proinflammatory state, and the attenuation of the innate immune response which may be linked etiologically to its pathogenesis.
Aim of the study:to assess the impact of comorbidities in patients with diagnosis of Covid-19 on outcome, in order to find the predictors of prolonged hospital stay, need for ICU admission or poor outcome
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19 with comorbidities | – | Diagnostic Test: realtime PCRPatients with COVID19 with at least one of the following comorbidities: 1. Hypertension 2. Diabetes 3. Cardiovascular disease 4. Chronic pulmonary disease 5. Obesity 6. Chronic liver disease 7. Chronic kidney disease 8. Collagen vascular disease 9. Autoimmune disease 10. Malignancy |
| COVID19 without comorbidities | – | Diagnostic Test: realtime PCRPatients with COVID19 without any of the previously mentioned comorbidities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. All patients will be subjected to full clinical assessment, some laboratory investigations which are potential marker of disease severity. Another studies include chest X ray and CT chest.
Key inclusion criteria (1 listed)
- Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| realtime PCRDetection of SARS-CoV-2 genes by realtime PCR | Diagnostic test | COVID19 with comorbidities, COVID19 without comorbidities |
Primary outcome
Rate of recovery/ ICU admission/ need for mechanical ventilation
Time frame: Baseline
The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.
Time to improvement
Time frame: Baseline
Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 32173574Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
- Background: PubMed 32271993Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10.
- Background: PubMed 27352628Badawi A, Ryoo SG. Prevalence of comorbidities in the Middle East respiratory syndrome coronavirus (MERS-CoV): a systematic review and meta-analysis. Int J Infect Dis. 2016 Aug;49:129-33. doi: 10.1016/j.ijid.2016.06.015. Epub 2016 Jun 21.
- 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.
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 6 Aug 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 Hebatallah Hassan (01022182086, heba.ismailhassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recovery/ ICU admission/ need for mechanical ventilation (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT04459390, which also lists 3 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 6 Aug 2020.