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

Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Amr Aly Abd elmoety

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.	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	it is estimated to be 2 weeks

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Amr Abd elmoety, PhD, Alexandria University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 12, 2020

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Sofosbuvir; Daclatasvir
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: 0305032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No