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

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ClinicalTrials.gov Identifier: NCT04757272
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, Zagazig University

Brief 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.

Condition or disease
Corona Virus Infection Hepatitis

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019 (COVID-19)?
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. incidence of chronic hepatitis C among COVID-19 hospitalized patients. [ Time Frame: 7 months ]
    incidence of chronic hepatitis C among COVID-19 hospitalized patients.


Secondary Outcome Measures :
  1. the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients [ Time Frame: 7 months ]
    the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All consecutive patients who were diagnosed to have COVID-19 during the period from May 2020 to January 2021 were included and their medical records were analyzed for the previous history of chronic hepatitis C and its management protocols. Any history to receive HCV treatment either (ACEI or ARBS), (Daclatasvir and Sofosbuvir), (Daclatasvir and Sofosbuvir plus Ribavirin), or (Ribavirin and Interferon) management protocols will be recorded
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757272


Contacts
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Contact: Sherif M Mowafy, MD 01003523374 ext 002 sherifmowafy2012@gmail.com
Contact: Essamedin M Negm, MD 01280985049 ext 002 alpherdawss@gmail.com

Locations
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Egypt
Zagazig University Hospitals Recruiting
Zagazig, Sharkia, Egypt, 44519
Contact: Sherif M Mowafy, MD    01003523374 ext 002    sherifmowafy2012@gmail.com   
Contact: Essamedin M Negm, MD    01280985049 ext 002    alpherdawss@gmail.com   
Sponsors and Collaborators
Zagazig University
Publications:

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Responsible Party: Sherif M. S. Mowafy, Associate professor of anesthesia and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier: NCT04757272    
Other Study ID Numbers: 6733-24-2-2021
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After publication
Access Criteria: by contacting the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Virus Diseases
Hepatitis C
Coronavirus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Coronaviridae Infections
Nidovirales Infections