COVID-19 DiseaseNCT04757792
Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU
An observational study of COVID-19 Disease, run by Benha University at 1 site in Egypt.
Trial summary
Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 Disease
- What is being tested?
- File inquiry
- How many people
- 475 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2020to 11 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with diagnosis of COVID-19
Who may be able to join
- assured diagnosis of COVID-19 by RT-PCR
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients.
Read the detailed description
The data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of NSAID as maintenance therapy or its recent administration before diagnosis of COVID-19 disease, presenting manifestations, laboratory and CT findings, applied therapies or interventions. Outcomes will be categorized as survival and non-survival outcome. Survivors will be subdivided as complete recovery or recovery with getting new morbidities. Mortality was subdivided as total hospital and ICU mortality. Data will be statistically analyzed in relation to outcomes
- Conditions
- COVID-19 Disease
- Being tested
- File inquiry
- Keywords
- COVID-19, NSAID, Aspirin, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
File inquiryOther
Also called No interventions
Data extraction out of file registry
| Study group | Role | What they receive |
|---|---|---|
| No NSAID | included patients who did not receive NSAID prior to having COVID-19 disease Receives: Other: File inquiry | |
| Apsirin | included patients who received acetylsalicylic acid (ASA) prior to having COVID-19 disease Receives: Other: File inquiry | |
| Celecoxib | included patients who received celecoxib (CEL) prior to having COVID-19 disease Receives: Other: File inquiry | |
| Miscellaneous | included patients who received miscellaneous NSAID other than ASA or CEL prior to having COVID-19 disease Receives: Other: File inquiry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
number of patients who were died secondary to COVID-19 disease or its complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start6 Jun 2020
- Primary completion1 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
- More trials run by Benha 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
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University, Cairo University
- Responsible party
- Principal investigator, Adel F. Alkholy, Benha University
- Investigators
- Adel Alkholy, Prof, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757792
- Sponsor's protocol ID
- RC1-2-2021
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol data will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU
- ClinicalTrials.gov ID
- NCT04757792
- Acronym / sponsor ID
- RC1-2-2021
- Conditions
- COVID-19 Disease
- Keywords
- COVID-19, NSAID, Aspirin, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Tanta University, Cairo University
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 17 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.
Retrospective multicenter study to evaluate the data of COVID-19 patients who were admitted to university hospitals in relation to their recent administration or maintenance on non-steroidal anti-inflammatory drugs (NSAID) prior to have COVID-19 disease and to analyze it in relation to outcome of these patients.
Detailed description
The data contained in hospital registry were collected, categorized into demographic, previous medical history, the use of NSAID as maintenance therapy or its recent administration before diagnosis of COVID-19 disease, presenting manifestations, laboratory and CT findings, applied therapies or interventions. Outcomes will be categorized as survival and non-survival outcome. Survivors will be subdivided as complete recovery or recovery with getting new morbidities. Mortality was subdivided as total hospital and ICU mortality. Data will be statistically analyzed in relation to outcomes
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No NSAID | – | Other: File inquiryincluded patients who did not receive NSAID prior to having COVID-19 disease |
| Apsirin | – | Other: File inquiryincluded patients who received acetylsalicylic acid (ASA) prior to having COVID-19 disease |
| Celecoxib | – | Other: File inquiryincluded patients who received celecoxib (CEL) prior to having COVID-19 disease |
| Miscellaneous | – | Other: File inquiryincluded patients who received miscellaneous NSAID other than ASA or CEL prior to having COVID-19 disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with diagnosis of COVID-19
Key inclusion criteria (1 listed)
- assured diagnosis of COVID-19 by RT-PCR
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| File inquiryAlso: No interventionsData extraction out of file registry | Other | Apsirin, Celecoxib, Miscellaneous, No NSAID |
Primary outcome
Mortality rate
Time frame: 6 months
number of patients who were died secondary to COVID-19 disease or its complications
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 17 Feb 2021.
- Individual participant dataSharing planned: Yes. Protocol data will be available on request
Related trials for COVID-19 Disease
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.
Adel Alkholy, Prof principal investigator
Benha University
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 COVID-19 Disease, run by Benha 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: finished, as of the sponsor's last update on 17 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?
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?
Mortality rate (time frame: 6 months). 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 17 Feb 2021.