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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04539834
Other study ID # (ZU-IRB#: 6328-23-8-2020)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date October 30, 2021

Study information

Verified date November 2021
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

SARS-CoV-2 invades human cells through binding angiotensin I converting enzyme 2 (ACE2) on the cell membrane. ACE2 is widely distributed in many types of human tissues, especially in the vital organs, such as heart, liver, kidney, and lungs. ACE2 is viewed as the principal counter-regulatory mechanism for the main axis of renin-angiotensin system (RAS) that is an essential player in the control of blood pressure and electrolyte balance. The final effect is to increase reabsorption of sodium and water, and thereafter increase blood pressure and excretion of potassium (K+). Besides, patients with COVID-19 often had gastrointestinal symptoms such as diarrhea and vomiting Early studies proved that high percentage of COVID-19 patient were presented with electrolyte disorders, including sodium, potassium, chloride and calcium abnormalities. Such electrolyte disturbances have important implications not only for patient management but also for identifying potential pathophysiologic mechanisms underlying COVID-19 that could drive novel therapeutic opportunities


Recruitment information / eligibility

Status Completed
Enrollment 983
Est. completion date October 30, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients = 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
electrolytes
measuring level of electrolytes

Locations

Country Name City State
Egypt Zagazig University Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection. To find any correlation between the level of the electrolyte disturbances and the morbidity and mortality of the disease . 4 months
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