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Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04773756
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Amr Aly Abd Elmoety, Alexandria University

Study Description
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Brief Summary:
Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on structural studies and multiple alignment analysis. By comparing the positive-stranded RNA genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal nucleotide analogue to repurpose for COVID-19 treatment

Condition or disease Intervention/treatment Phase
Covid19 Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : December 12, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sofosbuvir / Daclatsvir
A drug used in the treatment of HCV infection, given in the same dose 400mg and 60 mg respectively once daily for 14 days
 Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg
Giving these two drugs for treatment of COVID patients


Outcome Measures
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Primary Outcome Measures :
  1. evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19. [ Time Frame: it is estimated to be 2 weeks ]
    The study assesses the incidence of resolution of symptoms in COVID patients after taking Sofosbuvir and Daclatasvir for 14 days by doing PCR and the result to be negative


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild- moderate COVID-19 confirmed by PCR

Exclusion Criteria:

  1. Patients on renal dialysis
  2. Severe COVID-19 cases
  3. Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia).
  4. Children < 12 years
  5. Pregnant and breast feeding women
  6. Exacerbation of hepatitis B
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): NCT04773756


Locations
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Egypt
Amr Aly Abd elmoety
Alexandria, Egypt, 21521
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Amr Abd elmoety, PhD Alexandria University, Faculty of Medicine
More Information
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Responsible Party: Amr Aly Abd Elmoety, Professor, Internal Medicine Department, Alexandria University
ClinicalTrials.gov Identifier: NCT04773756    
Other Study ID Numbers: 0305032
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amr Aly Abd Elmoety, Alexandria University:
Sofosbuvir
Daclatasvir
Additional relevant MeSH terms:
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Sofosbuvir
Antiviral Agents
Anti-Infective Agents