Copeptin in COVID-19

COVID-19 Clinical Trial

Official title:

Copeptin; A Neuroendocrine Biomarker of COVID-19 Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249751
• Other study ID #: Al-Azhar Pharmacy
• Status: Completed
• Start date: June 20, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: February 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 10, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Assessement of serum copeptin by ELISA technique
Assessement of serum copeptin by ELISA technique

Locations

Country	Name	City	State
Egypt	Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)