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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 : Completed
First Posted : February 17, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, Zagazig University

Study Description
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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.

Study Design
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Study Type : Observational
Actual Enrollment : 2106 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
Actual Primary Completion Date : March 30, 2022
Actual Study Completion Date : July 30, 2022

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Groups and Cohorts
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Outcome Measures
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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


Eligibility Criteria
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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 march 2022 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:

-

Contacts and Locations
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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


Locations
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Egypt
Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44519
Sponsors and Collaborators
Zagazig University
More Information
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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: September 30, 2022
Last Verified: September 2022
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
COVID-19
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Coronaviridae Infections
Nidovirales Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases