NCT04949412

Brief Summary

his a prospective observational study will be conducted on 100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 11, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

June 30, 2021

Last Update Submit

November 1, 2021

Conditions

Covid19

Keywords

vitamin DCOVID-19Severity

Outcome Measures

Primary Outcomes (1)

  • serum level of vitamin D in patients who infected with COVID19

    during the period from the start of June 2021 to the end of July 2021

Study Arms (2)

non-severe COVID19

Patients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types or A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.

Diagnostic Test: Vitamin D

Severe Covid19

Severe pneumonia was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR ≥30 times/minute; ii) hypoxia: oxygen saturation (resting state) ≤93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) ≤ 300 mmHg (millimeters of Mercury); or iv) the occurrence of respiratory or other organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock

Diagnostic Test: Vitamin D

Interventions

Vitamin DDIAGNOSTIC_TEST

serum vitamin D level

Severe Covid19non-severe COVID19

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients who were diagnosed as SARS-CoV2 positive. The data will be collected from isolation hospital in Sohag governorate during the period from the start of June 2021 to the end of July 2021. Patients will be followed up for at least one month to evaluate the prognosis.

You may qualify if:

  • Patients with SARS-CoV2 positive PCR

You may not qualify if:

  • Patients with chronic obstructive lung disease Chronic renal failure Patients with malabsorption Organ transplant recipient Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mohammed Abdelrahman

Sohag, Egypt

Location

Related Publications (3)

  • Masoud HH, Zaky S, Baki AA. Management Protocol for COVID-19 Patients Version 1.4/30th May 2020 Ministry of health and population (MOHP), Egypt. 2020;(September)

    BACKGROUND

  • Laird E, Rhodes J, Kenny RA. Vitamin D and Inflammation: Potential Implications for Severity of Covid-19. Ir Med J. 2020 May 7;113(5):81.

    PMID: 32603576BACKGROUND

  • Mohammed M, Shafik NS, Maher A, Hemdan SB, Elhamed MA. Liver Injuries in COVID-19 infected patients. Sohag Medical Journal. 2020;24(2):15-19.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D Response Element

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Response ElementsEnhancer Elements, GeneticRegulatory Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaPromoter Regions, GeneticGenetic StructuresGenetic PhenomenaRegulatory Elements, TranscriptionalGene ComponentsGenesGenome ComponentsGenome

Study Officials

  • Mustafa Haridy, Deminstrator

    Al-Azahar University

    STUDY CHAIR

  • Mohamed Mahmoud, lecturer

    Sohag University

    STUDY CHAIR

  • Ahmed Nour-Eldin, lecturer

    Sohag University

    STUDY CHAIR

  • Asmaa Khalaf, lecturer

    Sohag University

    STUDY CHAIR

  • Amira Maher, lecturer

    Sohag University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mona Mohammed Abdelrhman

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 2, 2021

Study Start

June 11, 2021

Primary Completion

July 30, 2021

Study Completion

September 25, 2021

Last Updated

November 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)