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Clinical Trials/NCT04487951
NCT04487951
Unknown
Not Applicable

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

Cairo University1 site in 1 country100 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID19 Pneumonia
Sponsor
Cairo University
Enrollment
100
Locations
1
Primary Endpoint
NT-pro-BNP and Vitamin D
Last Updated
5 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha A. Radwan

Lecturer of Clinical and Chemical Pathology

Cairo University

Eligibility Criteria

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-
  • Concomitant heart failure.
  • Hypoxic patients on hospital admission.
  • Arrhythmia.

Outcomes

Primary Outcomes

NT-pro-BNP and Vitamin D

Time Frame: 6 month

level of NT-pro-BNP, and Vitamin D

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(6 month)

Study Sites (1)

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