Copeptin in COVID-19

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: Assessement of serum copeptin by ELISA technique

• Registration Number: NCT05249751
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

This prospective study enrolled 160 individuals with confirmed COVID-19 infection using PCR. They were recruited from Al-Zahraa Hospital, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt, which was specifically designated for the isolation of SARS-CoV-2 positive patients. According to the Egyptian ministry of health and population's (MOHP) recommendations, patients were divided into 80 mild-moderate COVID-19 patients and 80 severe COVID-19 patients. Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent), while severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent). All participants or their corresponding companions signed a free informed consent form. The study was approved by the research ethics committee of Al-Azhar University's Faculty of Medicine (Girls), Cairo, Egypt, with approval number (202106884), and adhered to the Helsinki Declaration's precepts. Pregnancy, COVID-19 patients with morbid obesity, cancer, or autoimmune disease, and those who took immunomodulators or initiated the COVID-19 treatment programme were excluded. Additionally, patients having a history of recurrent COVID-19 infection were excluded from the study.

Study Timeline

• Study Start: 2021-06-20
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-10
• Status Verified: 2022-02
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe	Assessement of serum copeptin by ELISA technique	severe cases met the following criteria: fever and respiratory symptoms, CORAD 4-5, and oxygen saturation (SpO2 92 percent).
mild-moderate	Assessement of serum copeptin by ELISA technique	Cases classified as mild-moderate fulfilled the following criteria: fever and respiratory symptoms, CORAD 1-5, and oxygen saturation (SpO2 92 percent),

Primary Outcome Measures

Name	Time	Method
The role of Copeptin in severity stratification of CoVID-19	By the end of the study (September 2021)	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.

Trial Locations

Locations (1)

Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt; 🇪🇬 Cairo, Egypt