Copeptin in COVID-19

NCT05249751 | Completed

• 1 other identifier: Al-Azhar Pharmacy
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the change in serum level of copeptin, a neuroendocrine biomarker, in differentiation between mild-moderate and severe COVID-19 cases on admission time and to find its diagnostic potential.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• The role of Copeptin in severity stratification of CoVID-19

  to determine the effect of COVID-19 severity on the serum copeptin level, which serves as a stress indicator for infection-related complications. Additionally, to link this effect with that of COVID-19's other inflammatory biomarkers, including C-reactive protein (CRP), ferritin, and D-dimer. Additionally, to investigate its utility as a differentiating factor amongst COVID-19 severity classes.

  By the end of the study (September 2021)

Study Arms (2)

mild-moderate

Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent),

Diagnostic Test: Assessement of serum copeptin by ELISA technique

Severe

severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent).

Diagnostic Test: Assessement of serum copeptin by ELISA technique

Interventions

Assessement of serum copeptin by ELISA technique DIAGNOSTIC_TEST

Assessement of serum copeptin by ELISA technique

Severe; mild-moderate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Egyptian patients recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt

You may qualify if:

• Adult patients \> 18 years with the positive result of real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) for SARS-CoV-2 RNA.
• Severity stratification is based on the guidance of the Egyptian MOH protocol.

You may not qualify if:

• Pregnant COVID-19 patients. COVID-19 patients with morbid obesity, malignancy, autoimmune diseases and those who received immunomodulators or began COVID-19 treatment protocol.
• Also, patients with a history of recurrent COVID-19 will be excluded.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Assistant of Medical Biochemistry and Molecular Biology

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: February 22, 2022
• Study Start: June 20, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 10, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)