NCT04539834

Brief Summary

Initial case reports and cohort studies have described many clinical characteristics of patients with coronavirus disease 2019 (COVID-19), an emerging infectious disorder caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In early COVID-19 studies, some evidence has been provided that electrolyte disorders may also be present upon patients' presentation, including sodium, potassium, chloride and calcium abnormalities the aim of the study is Identification of elements that affect COVID-19 pathology to improve survival and decrease mortality rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
983

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

May 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

September 1, 2020

Last Update Submit

November 20, 2021

Conditions

Keywords

Electrolytes; COVID-19

Outcome Measures

Primary Outcomes (1)

  • electrolytes disturbances in patients with COVID-19

    Serum Electrolytes (Na, K, Ca, Cl, Ph, Mg) abnormality in COVID 19 patients laboratory results in the different stages of the disease

    4 months

Secondary Outcomes (1)

  • To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.

    4 months

Interventions

measuring level of electrolytes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients ≥ 18 years old with diagnosis of COVID-19 infection who admitted to Isolation hospital of Zagazig University Hospitals during the period from 1 May 2020 to 1 August 2020.

You may qualify if:

  • Patients ≥ 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2.

You may not qualify if:

  • Patients who had other causes of electrolyte disturbances (9):
  • Chronic organ dysfunction (e.g., hepatic or renal dysfunction),
  • Terminal cancer, immunodeficiency, and
  • Patients with a history of long-term use of hormones \& Diuretics were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, 055, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Electrolytes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Tarek Hamdy, MD

    lecturer of Chest diseases, Faculty of Medicine, Zagazig University

    STUDY DIRECTOR
  • Hadeer El Shahaat, master degree

    Assistant lecturer of Chest diseases, Faculty of Medicine, Zagazig University

    PRINCIPAL INVESTIGATOR
  • Ahmed Abdulsaboor, MD

    Clinical Pathology Department, Faculty of Medicine, Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 7, 2020

Study Start

May 1, 2020

Primary Completion

August 1, 2021

Study Completion

October 30, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations