Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Phase 2

• Conditions: Covid19
• Interventions: Drug: Sofosbuvir; Drug: Daclatasvir

• Registration Number: NCT04497649
• Lead Sponsor: Tanta University

Brief Summary

efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Detailed Description

The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-08-01
• Study First Posted: 2020-08-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-03
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• COVID 19 positive patients

Exclusion Criteria

• COVID-19 patients with critical manifestations.
• Sepsis.
• Acute respiratory distress syndrome (ARDS).
• Decompensated liver disease (Child-Pugh class B or C disease).
• Chronic renal impairment.
• Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ....).
• Ischemic heart disease within the last 6 months.
• Chronic pulmonary disease.
• Malignancy.
• Pregnancy or breastfeeding.
• Hypersensitivity to sofosbuvir or ribavirin.
• Patients with organ transplant.
• Unwilling to participate in our study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir and Daklatasuvir	Daclatasvir	Sofosbuvir and Daklatasuvir with standard of care treatment
Sofosbuvir and Daklatasuvir	Sofosbuvir	Sofosbuvir and Daklatasuvir with standard of care treatment

Primary Outcome Measures

Name	Time	Method
Number of patients with improvement or mortality	1 month	The number of patients with improvement or mortality

Trial Locations

Locations (1)

Cairo and Tanta Universitities; 🇪🇬 Tanta, Egypt