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Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) (CCOVID-19)

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ClinicalTrials.gov Identifier: NCT04535869
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Mahmoud Elbendary, Mansoura University

Brief Summary:

COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed to have a high potential for transmission to close contacts on 20 January 2020 by the National Health Commission of China and it was announced as a pandemic by the WHO on 11 March 2020.

There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy.

Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based on the similarity between the replication mechanisms of the HCV and the coronaviruses.

Aim of our study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients according to MOHP protocol.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Sofosbuvir 400 MG plus Daclatasvir 200mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19)
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : September 3, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: A)standard therapy group
No intervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol
Active Comparator: B)Standard Therapy group plus Ant-HCV drugs
Intervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol plus sofosbuvir 400 mg and Daclatasvir 200mg
Drug: Sofosbuvir 400 MG plus Daclatasvir 200mg
This group which receive sofosbuvir and daclatasvir for 14 days plus standard therapy
Other Name: Direct antiviarl agents




Primary Outcome Measures :
  1. rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment [ Time Frame: for every case must be done after 2 weeks from the start of treatment. ]
    All PCR for COVID must be negative


Secondary Outcome Measures :
  1. resolution of pneumonia BY high resolution Computed tomography [ Time Frame: Computed tomography must be done after 2 weeks to detect resolution of pneumonia ]
    clinical status as assessed by earlier resolution of pneumonia in the intervention arm when compared to the control group



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All cases positive for COVID-19
  • Male and non-pregnant female patients,
  • 18 years of age or older,
  • All moderate and severe caseswith pneuomnia.

Exclusion Criteria:

  • Known allergy or hypersensitivity to the used medications
  • Known severe liver disease
  • Use of medications that are contraindicated with the trial medications and that could not be replaced or stopped during the trial period
  • Pregnancy or breast-feeding or known active HCV infection, because of concerns about the development of resistance
  • History of bone marrow transplant
  • Known G6PD deficiency
  • Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
  • Psoriasis
  • Porphyria
  • Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
  • Known history of long QT syndrome
  • Current known QTc>500 msec
  • Pregnant or nursing
  • Weight < 35kg
  • Seizure disorder
  • Patients receiving Amiodarone.

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): NCT04535869


Contacts
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Contact: Mahmoud El-Bendary, M.D 00201002592205 mmelbendary@gmail.com
Contact: Hatem Elalfy, M.D 00201224790518 elalfy_hatem66@yahoo.com

Locations
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Egypt
Mansoura Faculty of Medicine Recruiting
Mansoura, Dakahlyia, Egypt, 35516
Contact: Mahmoud El-Bendary, M.D    00201002592205    mmelbendary@gmail.com   
Sponsors and Collaborators
Mansoura University
Publications of Results:
Other Publications:
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Responsible Party: Mahmoud Elbendary, Professor of Tropical Medicine and Hepatogastroenterology, Mansoura University
ClinicalTrials.gov Identifier: NCT04535869    
Other Study ID Numbers: MS.20.08.1214
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Elbendary, Mansoura University:
COVID
Anti- HCV drugs,
Sofosbuvir
Daclatasvir
DAAs
Efficacy
Additional relevant MeSH terms:
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Sofosbuvir
Antiviral Agents
Anti-Infective Agents