N-terminal Pro B-type Natriuretic Peptide and Vitamin D Levels as Prognostic Markers in COVID-19 Pneumonia

NCT ID: NCT04487951

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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

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COVID19 Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Moderate

Moderate: moderate COVID -19 pneumonia

Pro BNP , Vitamin D

Intervention Type OTHER

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.

Severe

\_severe COVID-19 pneumonia

Pro BNP , Vitamin D

Intervention Type OTHER

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.

Interventions

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Pro BNP , Vitamin D

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Other causes of pneumonia other than infection with SARS-CoV-2.

* Concomitant heart failure.
* Hypoxic patients on hospital admission.
* Arrhythmia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha A. Radwan

Lecturer of Clinical and Chemical Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akram Abdelbary, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Alainy Cairo University

Cairo, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Noha A. Radwan, Lecturer of Chemical pathology

Role: CONTACT

01152003668

Yasmine Elshiwy, Ass. Prof.

Role: CONTACT

+201005002408

Facility Contacts

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Noha A. Radwan, Lecturer

Role: primary

01152003668

Noha Radwan, Lecturer

Role: backup

01152003668

Other Identifiers

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2020-7-1

Identifier Type: -

Identifier Source: org_study_id

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