NCT04487951

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 24, 2020

Last Update Submit

July 24, 2020

Conditions

Keywords

NT-pro-BNPVitamin DCOVID-19 PneumoniaHPLC/UV Diode array

Outcome Measures

Primary Outcomes (1)

  • NT-pro-BNP and Vitamin D

    level of NT-pro-BNP, and Vitamin D

    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

    6 month

Study Arms (2)

Moderate

Moderate: moderate COVID -19 pneumonia

Other: Pro BNP , Vitamin D

Severe

\_severe COVID-19 pneumonia

Other: Pro BNP , Vitamin D

Interventions

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.

ModerateSevere

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Other causes of pneumonia other than infection with SARS-CoV-2.
  • Concomitant heart failure.
  • Hypoxic patients on hospital admission.
  • Arrhythmia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Cairo University

Cairo, Giza Governorate, 11562, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Akram Abdelbary, Prof.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha A. Radwan, Lecturer of Chemical pathology

CONTACT

Yasmine Elshiwy, Ass. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical and Chemical Pathology

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 27, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

January 1, 2021

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations