COVID-19NCT05249751
Copeptin in COVID-19
An observational study of COVID-19, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to investigate the change in serum level of copeptin, a neuroendocrine biomarker, in differentiation between mild-moderate and severe COVID-19 cases on admission time and to find its diagnostic potential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Assessement of serum copeptin by ELISA technique
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2021to 10 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptian patients recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt
Who may be able to join
- Adult patients > 18 years with the positive result of real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) for SARS-CoV-2 RNA.
- Severity stratification is based on the guidance of the Egyptian MOH protocol.
Who cannot join
- Pregnant COVID-19 patients. COVID-19 patients with morbid obesity, malignancy, autoimmune diseases and those who received immunomodulators or began COVID-19 treatment protocol.
- Also, patients with a history of recurrent COVID-19 will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Copeptin; A Neuroendocrine Biomarker of COVID-19 Severity
This study aimed to investigate the change in serum level of copeptin, a neuroendocrine biomarker, in differentiation between mild-moderate and severe COVID-19 cases on admission time and to find its diagnostic potential.
Read the detailed description
This prospective study enrolled 160 individuals with confirmed COVID-19 infection using PCR. They were recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt, which was specifically designated for the isolation of SARS-CoV-2 positive patients. According to the Egyptian ministry of health and population's (MOHP) recommendations, patients were divided into 80 mild-moderate COVID-19 patients and 80 severe COVID-19 patients. Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), while severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). All participants or their corresponding companions signed a free informed consent form. The study was approved by the research ethics committee of Al-Azhar University's Faculty of Medicine (Girls), Cairo, Egypt, with approval number (202106884), and adhered to the Helsinki Declaration's precepts. Pregnancy, COVID-19 patients with morbid obesity, cancer, or autoimmune disease, and those who took immunomodulators or initiated the COVID-19 treatment programme were excluded. Additionally, patients having a history of recurrent COVID-19 infection were excluded from the study.
- Conditions
- COVID-19
- Being tested
- Assessement of serum copeptin by ELISA technique
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessement of serum copeptin by ELISA techniqueDiagnostic test
Assessement of serum copeptin by ELISA technique
| Study group | Role | What they receive |
|---|---|---|
| mild-moderate | Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), Receives: Diagnostic Test: Assessement of serum copeptin by ELISA technique | |
| Severe | severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). Receives: Diagnostic Test: Assessement of serum copeptin by ELISA technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of Copeptin in severity stratification of CoVID-19
to determine the effect of COVID-19 severity on the serum copeptin level, which serves as a stress indicator for infection-related complications. Additionally, to link this effect with that of COVID-19's other inflammatory biomarkers, including C-reactive protein (CRP), ferritin, and D-dimer. Additionally, to investigate its utility as a differentiating factor amongst COVID-19 severity classes.
Measured: By the end of the study (September 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start20 Jun 2021
- Primary completion31 Aug 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshafei, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249751
- Sponsor's protocol ID
- Al-Azhar Pharmacy
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Through the published research article
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin; A Neuroendocrine Biomarker of COVID-19 Severity
- ClinicalTrials.gov ID
- NCT05249751
- Acronym / sponsor ID
- Al-Azhar Pharmacy
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 22 Feb 2022 (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.
This study aimed to investigate the change in serum level of copeptin, a neuroendocrine biomarker, in differentiation between mild-moderate and severe COVID-19 cases on admission time and to find its diagnostic potential.
Detailed description
This prospective study enrolled 160 individuals with confirmed COVID-19 infection using PCR. They were recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt, which was specifically designated for the isolation of SARS-CoV-2 positive patients. According to the Egyptian ministry of health and population's (MOHP) recommendations, patients were divided into 80 mild-moderate COVID-19 patients and 80 severe COVID-19 patients. Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), while severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). All participants or their corresponding companions signed a free informed consent form. The study was approved by the research ethics committee of Al-Azhar University's Faculty of Medicine (Girls), Cairo, Egypt, with approval number (202106884), and adhered to the Helsinki Declaration's precepts. Pregnancy, COVID-19 patients with morbid obesity, cancer, or autoimmune disease, and those who took immunomodulators or initiated the COVID-19 treatment programme were excluded. Additionally, patients having a history of recurrent COVID-19 infection were excluded from the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild-moderate | – | Diagnostic Test: Assessement of serum copeptin by ELISA techniqueCases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), |
| Severe | – | Diagnostic Test: Assessement of serum copeptin by ELISA techniquesevere cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt
Key inclusion criteria (2 listed)
- Adult patients > 18 years with the positive result of real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) for SARS-CoV-2 RNA.
- Severity stratification is based on the guidance of the Egyptian MOH protocol.
Key exclusion criteria (2 listed)
- Pregnant COVID-19 patients. COVID-19 patients with morbid obesity, malignancy, autoimmune diseases and those who received immunomodulators or began COVID-19 treatment protocol.
- Also, patients with a history of recurrent COVID-19 will be excluded.
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 |
|---|---|---|
| Assessement of serum copeptin by ELISA techniqueAssessement of serum copeptin by ELISA technique | Diagnostic test | Severe, mild-moderate |
Primary outcome
The role of Copeptin in severity stratification of CoVID-19
Time frame: By the end of the study (September 2021)
to determine the effect of COVID-19 severity on the serum copeptin level, which serves as a stress indicator for infection-related complications. Additionally, to link this effect with that of COVID-19's other inflammatory biomarkers, including C-reactive protein (CRP), ferritin, and D-dimer. Additionally, to investigate its utility as a differentiating factor amongst COVID-19 severity classes.
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 22 Feb 2022.
- Individual participant dataSharing planned: No. Through the published research article
Related trials for COVID-19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
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.
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, run by Al-Azhar 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 2 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 22 Feb 2022. 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?
The role of Copeptin in severity stratification of CoVID-19 (time frame: By the end of the study (September 2021)). 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 22 Feb 2022.