Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019?

Corona Virus Infection Clinical Trial

Official title:

Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019 (COVID-19)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757272
• Other study ID #: 6733-24-2-2021
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Modulation of the renin angiotensin system by the chronic hepatitis C virus treatment either by (Daclatasvir and Sofosbuvir), (Daclatasvir and Sofosbuvir plus Ribavirin), or (Ribavirin and Interferon) protocols could give an explanation for the low incidence of COVID-19 among Egyptian population. Adding it may play a role in COVID 19 prophylaxis.

Description:

The interaction of severe acute respiratory syndrome corona virus-2 (SARS-CoV-2) and the renin angiotensin system (RAS) via angiotensin converting enzyme-2 (ACE-2), the receptor used by the SARS-CoV-2 to gain access to cells could provide an explanation for the several unusual clinical findings observed in COVID-19 Although chronic hepatitis is one of the risk factors listed by WHO for severe COVID-19, low incidence of COVID-19 was observed among HCV patients admitted to Egyptian hospitals. Modulation of the RAS by the chronic hepatitis C virus treatment either by (ACEI or ARBS), (Daclatasvir and Sofosbuvir), (Daclatasvir and Sofosbuvir plus Ribavirin), or (Ribavirin and Interferon) protocols could give an explanation for the low incidence of COVID-19 among Egyptian population. Adding it may play a role in COVID 19 prophylaxis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2106
• Est. completion date: July 30, 2022
• Est. primary completion date: March 30, 2022
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• All consecutive patients who were diagnosed to have COVID-19 and admitted to Zagazig University Hospitals during the period from May 2020 to January 2021 Exclusion Criteria: -

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Hepatitis
• Hepatitis A
• Hepatitis C
• Virus Diseases

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Husic-Selimovic A, Sofic A, Huskic J, Bulja D. Effect of Antiviral Therapy on Serum Activity of Angiotensin Converting Enzyme in Patients with Chronic Hepatitis C. Med Arch. 2016 Apr;70(2):92-6. doi: 10.5455/medarh.2016.70.92-96. Epub 2016 Apr 1. — View Citation

Imai Y, Kuba K, Rao S, Huan Y, Guo F, Guan B, Yang P, Sarao R, Wada T, Leong-Poi H, Crackower MA, Fukamizu A, Hui CC, Hein L, Uhlig S, Slutsky AS, Jiang C, Penninger JM. Angiotensin-converting enzyme 2 protects from severe acute lung failure. Nature. 2005 Jul 7;436(7047):112-6. — View Citation

Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, Somasundaran M, Sullivan JL, Luzuriaga K, Greenough TC, Choe H, Farzan M. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature. 2003 Nov 27;426(6965):450-4. — View Citation

Omran D, Alboraie M, Zayed RA, Wifi MN, Naguib M, Eltabbakh M, Abdellah M, Sherief AF, Maklad S, Eldemellawy HH, Saad OK, Khamiss DM, El Kassas M. Towards hepatitis C virus elimination: Egyptian experience, achievements and limitations. World J Gastroenterol. 2018 Oct 14;24(38):4330-4340. doi: 10.3748/wjg.v24.i38.4330. Review. — View Citation

Paz Ocaranza M, Riquelme JA, García L, Jalil JE, Chiong M, Santos RAS, Lavandero S. Counter-regulatory renin-angiotensin system in cardiovascular disease. Nat Rev Cardiol. 2020 Feb;17(2):116-129. doi: 10.1038/s41569-019-0244-8. Epub 2019 Aug 19. Review. — View Citation

Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium, Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum in: JAMA. 2020 May 26;323(20):2098. — View Citation

Wiese OJ, Allwood BW, Zemlin AE. COVID-19 and the renin-angiotensin system (RAS): A spark that sets the forest alight? Med Hypotheses. 2020 Nov;144:110231. doi: 10.1016/j.mehy.2020.110231. Epub 2020 Sep 3. — View Citation

Zakaria S, El-Sisi AE. Daclatasvir and Sofosbuvir Mitigate Hepatic Fibrosis Through Downregulation of TNF-a / NF-?B Signaling Pathway. Curr Mol Pharmacol. 2020;13(4):318-327. doi: 10.2174/1874467213666200116114919. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of chronic hepatitis C among COVID-19 hospitalized patients.	incidence of chronic hepatitis C among COVID-19 hospitalized patients.	7 months
Secondary	the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients	the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients	7 months