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AzTrials

Corona Virus InfectionNCT04757272

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

An observational study of Corona Virus Infection and Hepatitis, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Corona Virus Infection, Hepatitis
How many people
2,106 participants
Where
1 siteEgypt
Study dates
1 May 2020to 30 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Zagazig University Hospitals

    Zagazig, Sharqia Province, 44519

Other trials in Egypt

About this study

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

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.

Read the 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.

Medical subject headings
Coronavirus Infections, Hepatitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of chronic hepatitis C among COVID-19 hospitalized patients.

    incidence of chronic hepatitis C among COVID-19 hospitalized patients.

    Measured: 7 months

Secondary outcomes (1)

  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

    the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start1 May 2020
  3. Primary completion30 Mar 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757272
Sponsor's protocol ID
6733-24-2-2021
Status last verified
Sep 2022
First submitted
12 Feb 2021
Last updated
30 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication

Publications

  • 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.

    PubMed 33254538

  • Paz Ocaranza M, Riquelme JA, Garcia 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.

    PubMed 31427727

  • 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. doi: 10.1038/nature03712.

    PubMed 16001071

  • 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. doi: 10.1038/nature02145.

    PubMed 14647384

  • 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.

    PubMed 27147779

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

    PubMed 31951178

  • 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.

    PubMed 30344418

  • 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.

    PubMed 32320003

Questions about this trial

What is this clinical trial studying?

An observational study of Corona Virus Infection and Hepatitis, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of chronic hepatitis C among COVID-19 hospitalized patients. (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757272, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.

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