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

NCT04773756 | Completed Phase 4 FDA Drug

• 1 other identifier: 0305032
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

Sofosbuvir; Daclatasvir

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sofosbuvir / Daclatsvir

OTHER

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

Interventions

Sofosbuvir 400 MG/ Daclatasvir 60mg DRUG

Giving these two drugs for treatment of COVID patients

Sofosbuvir / Daclatsvir

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• mild- moderate COVID-19 confirmed by PCR

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Amr Aly Abd elmoety

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Amr Abd elmoety, PhD

  Alexandria University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine Department

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: November 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 12, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)