Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients

Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.

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

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Drug: Sofosbuvir; Drug: Daclatasvir

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Cairo and Tanta Universitities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sofosbuvir and Daklatasuvir; Sofosbuvir and Daklatasuvir with standard of care treatment	Drug: Sofosbuvir; Sofosbuvir once daily; Other Names: Mpiviropack, Sovaldy, soflanork; Drug: Daclatasvir; daclatasuvir once daily; Other Names: daklinza, daklanork
No Intervention: Standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with improvement or mortality	The number of patients with improvement or mortality	1 month

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sherief Abd-Elsalam, ass. prof., Tanta University Faculty of medicine; Principal Investigator: Marwa Salama, Lecturer, Tanta university - faculty of medicine; Principal Investigator: Ahmed Cordie, lecturer, Cairo University; Principal Investigator: Gamal Esmat, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 10, 2021

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: August 1, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: Tanta sofosbuvir covid

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