Sofosbuvir in Treatment of COVID 19

December 3, 2020 updated by: Sherief Abd-Elsalam, Tanta University

Sofosbuvir Based Regimens in Treatment of COVID 19 Patients

Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Covid positive patients.

Exclusion Criteria:

  • Contraindication to sofosbuvir or ribavirin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sofosbuvir and ledipsavir
Sofosbuvir and ledipsavir plus standard of care treatment.
Drug: Sofosbuvir ledipsavir
Sofosbuvir ledipsavir once daily
Other Names:
  • mpiviropack plus
Experimental: Sofosbuvir and Daklatasuvir
Sofosbuvir and Daklatasuvir plus standard of card treatment..
Drug: sofosbuvir
Sofosbuvir once daily
Other Names:
  • Mpiviropack, Sovaldy, soflanork
Drug: Daclatasvir
Daklatasuvir tablets
Other Names:
  • daklinza
No Intervention: Standard treatment
Standard treatment alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with response to treatment
Time Frame: 1 month
The total number of patients with response to treatment
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Marwa Salama, Consultant, Tanta university - faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

July 4, 2020

First Submitted That Met QC Criteria

July 4, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sofosbuvir

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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