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

NCT ID: NCT04773756

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2020-12-12

Brief Summary

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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

Detailed Description

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Conditions

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Covid19

Keywords

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Sofosbuvir Daclatasvir

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Sofosbuvir 400 MG/ Daclatasvir 60mg

Intervention Type DRUG

Giving these two drugs for treatment of COVID patients

Interventions

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Sofosbuvir 400 MG/ Daclatasvir 60mg

Giving these two drugs for treatment of COVID patients

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Amr Aly Abd Elmoety

Professor, Internal Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Abd elmoety, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University, Faculty of Medicine

Locations

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Amr Aly Abd elmoety

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0305032

Identifier Type: -

Identifier Source: org_study_id