COVID19 PneumoniaNCT04487951
N-terminal Pro B-type Natriuretic Peptide and Vitamin D Levels as Prognostic Markers in COVID-19 Pneumonia
An observational study of COVID19 Pneumonia, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill category compared to those who did not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19 Pneumonia
- What is being tested?
- Pro BNP , Vitamin D
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Jan 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
- Adult, Older adult
Study population: The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to moderate cases (lung shadows without hypoxia and oxygen saturation >92%) who progressed to severe illness characterized by hypoxia necessitating oxygen therapy, or critical illness characterized by respiratory failure necessitating mechanical ventilation either invasive or non-invasive within their hospital stay. Group (2): 50 mild to moderate cases who did not show clinical progression and were discharged.
Who may be able to join
- All cases will be diagnosed with COVID-19 by RT-PCR • Group (1) Critically ill patients: Respiratory Rate > 30/min SaO2 < 92% at room temperature Chest radiology showing more than 50% lesion or progressive lesion within 24 to 48 hours • Group (2) moderate cases: Patients has pneumonia manifestations on radiology associated with symptoms \&/or leucopenia or lymphopenia.
Who cannot join
- Other causes of pneumonia other than infection with SARS-CoV-2.
- Concomitant heart failure.
- Hypoxic patients on hospital admission.
- Arrhythmia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy Cairo University
Cairo, Giza Governorate, 11562
Noha A. Radwan, Lecturer, 01152003668, nohakhaled11@gmail.com
Noha Radwan, Lecturer, 01152003668, nohakhaled11@gmail.com
About this study
This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection.
Read the detailed description
On 30 January 2020, World Health Organization (WHO) officially declared the COVID-19 epidemic as a public health emergency of international concern. An acute respiratory disease, caused by a novel coronavirus (SARS-CoV-2, previously known as 2019-nCoV), the coronavirus disease 2019 (COVID-19) has spread throughout China and received worldwide attention (Guo et al., 2020).
As an emerging acute respiratory infectious disease, COVID-19 primarily spreads through the respiratory tract, by droplets, respiratory secretions, and direct contact (Li et al., 2020). Based on current epidemiological investigation, the incubation period is 1-14 days, mostly 3-7 days and the COVID-19 is contagious during the latency period (Jin et al., 2020). The common clinical manifestations included fever (88.7%), cough (67.8%), fatigue (38.1%), sputum production (33.4%), shortness of breath (18.6%), sore throat (13.9%), and headache (13.6%) [16]. In addition, a part of patients manifested gastrointestinal symptoms, with diarrhea (3.8%) and vomiting (5.0%) (Guan et al., 2020).
B-type Natriuretic Peptide (BNP) is mainly synthesized and secreted by myocytes in the left ventricle (LV) as a response to myocytes stretched by pressure overload or volume expansion of the ventricle (Cao et al., 2019). In patients with Community Acquired Peumonia (CAP), NT-pro BNP levels are powerful predictors of adverse cardiac events. For patients with systemic inflammatory response syndrome (SIRS), Chen et al found that compared with non-SIRS patients, subjects with SIRS had a markedly higher level of B-type natriuretic peptide (BNP). Additionally, BNP level of more than 113 pg/mL was independent predictor of all-cause mortality in septic patients. Additionally, in 302 CAP patients, Christ-Crain et al confirmed that BNP levels increased with rising disease severity as classified by the pulmonary severity index (PSI) (p=0.01). Li et al confirmed that BNP could be used as a biomarker for evaluating the severity of CAP. They recommended BNP level of 299.0 pg/mL in predicting in-hospital mortality (sensitivity 67.5%, specificity 81.6%) (Zhang et al., 2016).
In respiratory system conditions, such as influenza, vitamin D has wide-ranging and fundamental roles, including through: gene transcription via COVID-19 relevant VDR (Vitamin D Receptor) pathways; wider immune function; and airway epithelial cell tight-junction function and integrity. Further, studies suggest vitamin D supplementation may be protective in respiratory conditions, the effect being highly significant in 'D' deficient persons. It is hypothesized by Watkins, 2020 and Grant et al., 2020 that vitamin D insufficiency may significantly compromise, respiratory immune response function, greatly increasing risk of COVID-19 severity and mortality (Brown and Sarkar, 2020).
Primary outcomes: This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
Secondary outcomes: Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection.
The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to moderate cases (lung shadows without hypoxia and oxygen saturation >92%) who progressed to severe illness characterized by hypoxia necessitating oxygen therapy, or critical illness characterized by respiratory failure necessitating mechanical ventilation either invasive or non-invasive within their hospital stay.
Group (2): 50 mild to moderate cases who did not show clinical progression and were discharged.
- Conditions
- COVID19 Pneumonia
- Being tested
- Pro BNP , Vitamin D
- Keywords
- NT-pro-BNP, Vitamin D, COVID-19 Pneumonia, HPLC/UV Diode array
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro BNP , Vitamin DOther
This study is designed to assess the difference between level of NT-pro-BNP, and Vitamin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
| Study group | Role | What they receive |
|---|---|---|
| Moderate | Moderate: moderate COVID -19 pneumonia Receives: Other: Pro BNP , Vitamin D | |
| Severe | _severe COVID-19 pneumonia Receives: Other: Pro BNP , Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-pro-BNP and Vitamin D
level of NT-pro-BNP, and Vitamin D
Measured: 6 month
Secondary outcomes (1)
Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection
Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Jul 2020
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19 PneumoniaStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Noha A. Radwan, Cairo University
- Investigators
- Akram Abdelbary, Prof., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487951
- Sponsor's protocol ID
- 2020-7-1
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-terminal Pro B-type Natriuretic Peptide and Vitamin D Levels as Prognostic Markers in COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04487951
- Acronym / sponsor ID
- 2020-7-1
- Conditions
- COVID19 Pneumonia
- Keywords
- NT-pro-BNP, Vitamin D, COVID-19 Pneumonia, HPLC/UV Diode array
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 27 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.
This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection.
Detailed description
On 30 January 2020, World Health Organization (WHO) officially declared the COVID-19 epidemic as a public health emergency of international concern. An acute respiratory disease, caused by a novel coronavirus (SARS-CoV-2, previously known as 2019-nCoV), the coronavirus disease 2019 (COVID-19) has spread throughout China and received worldwide attention (Guo et al., 2020).
As an emerging acute respiratory infectious disease, COVID-19 primarily spreads through the respiratory tract, by droplets, respiratory secretions, and direct contact (Li et al., 2020). Based on current epidemiological investigation, the incubation period is 1-14 days, mostly 3-7 days and the COVID-19 is contagious during the latency period (Jin et al., 2020). The common clinical manifestations included fever (88.7%), cough (67.8%), fatigue (38.1%), sputum production (33.4%), shortness of breath (18.6%), sore throat (13.9%), and headache (13.6%) [16]. In addition, a part of patients manifested gastrointestinal symptoms, with diarrhea (3.8%) and vomiting (5.0%) (Guan et al., 2020).
B-type Natriuretic Peptide (BNP) is mainly synthesized and secreted by myocytes in the left ventricle (LV) as a response to myocytes stretched by pressure overload or volume expansion of the ventricle (Cao et al., 2019). In patients with Community Acquired Peumonia (CAP), NT-pro BNP levels are powerful predictors of adverse cardiac events. For patients with systemic inflammatory response syndrome (SIRS), Chen et al found that compared with non-SIRS patients, subjects with SIRS had a markedly higher level of B-type natriuretic peptide (BNP). Additionally, BNP level of more than 113 pg/mL was independent predictor of all-cause mortality in septic patients. Additionally, in 302 CAP patients, Christ-Crain et al confirmed that BNP levels increased with rising disease severity as classified by the pulmonary severity index (PSI) (p=0.01). Li et al confirmed that BNP could be used as a biomarker for evaluating the severity of CAP. They recommended BNP level of 299.0 pg/mL in predicting in-hospital mortality (sensitivity 67.5%, specificity 81.6%) (Zhang et al., 2016).
In respiratory system conditions, such as influenza, vitamin D has wide-ranging and fundamental roles, including through: gene transcription via COVID-19 relevant VDR (Vitamin D Receptor) pathways; wider immune function; and airway epithelial cell tight-junction function and integrity. Further, studies suggest vitamin D supplementation may be protective in respiratory conditions, the effect being highly significant in 'D' deficient persons. It is hypothesized by Watkins, 2020 and Grant et al., 2020 that vitamin D insufficiency may significantly compromise, respiratory immune response function, greatly increasing risk of COVID-19 severity and mortality (Brown and Sarkar, 2020).
Primary outcomes: This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
Secondary outcomes: Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection.
The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to moderate cases (lung shadows without hypoxia and oxygen saturation >92%) who progressed to severe illness characterized by hypoxia necessitating oxygen therapy, or critical illness characterized by respiratory failure necessitating mechanical ventilation either invasive or non-invasive within their hospital stay.
Group (2): 50 mild to moderate cases who did not show clinical progression and were discharged.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate | – | Other: Pro BNP , Vitamin DModerate: moderate COVID -19 pneumonia |
| Severe | – | Other: Pro BNP , Vitamin D_severe COVID-19 pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to moderate cases (lung shadows without hypoxia and oxygen saturation >92%) who progressed to severe illness characterized by hypoxia necessitating oxygen therapy, or critical illness characterized by respiratory failure necessitating mechanical ventilation either invasive or non-invasive within their hospital stay. Group (2): 50 mild to moderate cases who did not show clinical progression and were discharged.
Key inclusion criteria (1 listed)
- All cases will be diagnosed with COVID-19 by RT-PCR • Group (1) Critically ill patients: Respiratory Rate > 30/min SaO2 < 92% at room temperature Chest radiology showing more than 50% lesion or progressive lesion within 24 to 48 hours • Group (2) moderate cases: Patients has pneumonia manifestations on radiology associated with symptoms \&/or leucopenia or lymphopenia.
Key exclusion criteria (4 listed)
- Other causes of pneumonia other than infection with SARS-CoV-2.
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 |
|---|---|---|
| Pro BNP , Vitamin DThis study is designed to assess the difference between level of NT-pro-BNP, and Vitamin D in moderate cases who progressed to severe or critically ill category compared to those who did not. | Other | Moderate, Severe |
Primary outcome
NT-pro-BNP and Vitamin D
Time frame: 6 month
level of NT-pro-BNP, and Vitamin D
1 secondary outcome
Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Akram Abdelbary, Prof. principal investigator
Cairo 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 COVID19 Pneumonia, 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 4 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 27 Jul 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 Noha A. Radwan, Lecturer of Chemical pathology (01152003668, nohakhaled11@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-pro-BNP and Vitamin D (time frame: 6 month). 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 27 Jul 2020.