NCT05946499

Brief Summary

Coronavirus disease 2019 (COVID-19) is a novel infectious disease that has been spreading worldwide Coronaviridae study group of the International Committee on taxonomy of viruses (2020). The clinical manifestation of COVID-19 can range from asymptomatic infection to critical illness with severe pneumonia, respiratory failure, and death. Vitamin A is of special interest in the field of infectious diseases, especially for pulmonary infections. It is crucial for the development of normal lung tissue and tissue repair after injury due to infection. Therefore, it may play a role in recovery after severe COVID-19 pneumonia. Vitamin A has immune regulatory functions and positively affects both the innate and adaptive immune cell response. The anti-oxidant Vitamin E, and trace element selenium, are major components of anti-oxidant defense. Epidemiological studies demonstrate that deficiencies in, either of these nutrients, alters immune responses and viral pathogenicity. Data concerning vitamin A and E plasma levels in COVID-19 patients are lacking. Therefore, this study aims at characterizing vitamin A and E plasma levels in COVID-19 and analyzing the association of plasma levels with disease severity and outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

July 12, 2023

Last Update Submit

August 18, 2023

Conditions

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Correlating between vitamin A and E deficiency and severity of SARS-COV2

    Evaluation of vitamin A and E deficiency with COVID-19 disease severity

    From September 2021 to November 2022

Study Arms (3)

Group A

30 ICU-admitted SARS-CoV-2- infected individuals with ARDS or in need of oxygen supplementation

Group B

30 ward-admitted SARS-CoV-2-infected individuals not suffering from ARDS and not in need of oxygen supplementation

Group C

30 sex and age-matched normal individuals

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COVID=19 patients recruited from ICU (intensive care Unit) and chest ward

You may qualify if:

  • COVID-19 positive patients by PCR (polymerase chain reaction) test
  • Patients aging 18 to 75 years

You may not qualify if:

  • Patients with known immunodeficiency - Patients with known lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

balsam Sherif Fahmy

Cairo, None Selected, 11511, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 14, 2023

Study Start

September 1, 2021

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations